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PROTEINS, VACCINES
R&D Alliance for Eye Disease Cell Therapies. BlueRock Therapeutics, Fujifilm Cellular Dynamics, and Opsis Therapeutics enter R&D pact to discover and develop cell therapies for eye diseases. Tim Wright, Editor, Contract Pharma 05.17.21.DRUG DELIVERY
Inhaled Drug Delivery Technology. The success of any new inhaled medicine relies in a large part on the correct combination of formulation and device technology being chosen for its delivery. Dr. Sandy Munro, Vice President – Pharmaceutical Development, Vectura01.27.21.
NUTRACEUTICAL MANUFACTURING: MEETING THE CHALLENGES OF The arrival of COVID-19 in the U.S. last spring led to significant disruption of raw material supplies, which coincided with spikes in demand for health products, particularly dietary supplements positioned for immune support. CONFERENCE CONTRACT PHARMA The Web Series will take place September 9 – 30, 2021. The 21st Annual Contracting & Outsourcing Conference & Tabletop Exhibition will be held September 22-23, 2022 at Hyatt Regency New Brunswick, NJ, located in the heart of New Jersey’s pharmaceutical industry. The two-day conference and one-day exhibition on September 22nd providesthe
ORAL SOLIDS: MARKET & TECHNOLOGY TRENDS The global OSD pharmaceutical formulation market is forecasted to grow from $493 billion in 2017 to $926 billion by the end of 2027, according to Future Market Insights. This represents a compound annual growth rate (CAGR) of 6.5% over the 10-year forecast period. MANUFACTURING CONTROLLED DRUGS Manufacturing Controlled Drugs . Guidelines for manufacture & formulation of Schedule II drugs . By Scott Silaika. Aesica Pharmaceuticals . The manufacture of controlled drugs is a vital and necessary part of today’s pharmaceutical industry that looks set togrow
ENVIRONMENTAL MONITORING The development of an environmental monitoring strategy and policy is a basic first stage to maintaining control of an environment. Key questions are what specifications are required and where these specifications will most likely be challenged. Depending on the product, the specifications to manufacture may be predefined 1. THE TOP 50 BIOPHARMA PRODUCTS A list of the best-selling biopharma products from 2010 OVERCOMING THE TECH TRANSFER CHALLENGE Natraj Ram, Jennifer L. Bixler and Don R. Durham 08.22.05. T he effectiveness of technology transfer is one of the key determinants in the success of a contract-manufacturing project. In most cases, it is the biggest unknown with respect to timelines, cost and expertise DISTINGUISHING DEVICES FROM DRUGS John G. Moore, J.D., Ph.D. and Adele M. Kaplan Gilpin, J.D., Ph.D. 11.14.11. In June 2011, the Food and Drug Administration (FDA) published two companion draft guidance documents to assist industry and FDA staff in distinguishing medical devices from drugs. There has been a pressing need for guidance as the number of “drug-like”devices has
PHARMACEUTICAL AND BIOPHARMACEUTICAL CONTRACT SERVICINGANALYTICAL SERVICESBIOANALYTICAL SERVICESBIOASSAY DEVELOPEMENTBIOLOGICS,PROTEINS, VACCINES
R&D Alliance for Eye Disease Cell Therapies. BlueRock Therapeutics, Fujifilm Cellular Dynamics, and Opsis Therapeutics enter R&D pact to discover and develop cell therapies for eye diseases. Tim Wright, Editor, Contract Pharma 05.17.21.DRUG DELIVERY
Inhaled Drug Delivery Technology. The success of any new inhaled medicine relies in a large part on the correct combination of formulation and device technology being chosen for its delivery. Dr. Sandy Munro, Vice President – Pharmaceutical Development, Vectura01.27.21.
NUTRACEUTICAL MANUFACTURING: MEETING THE CHALLENGES OF The arrival of COVID-19 in the U.S. last spring led to significant disruption of raw material supplies, which coincided with spikes in demand for health products, particularly dietary supplements positioned for immune support. CONFERENCE CONTRACT PHARMA The Web Series will take place September 9 – 30, 2021. The 21st Annual Contracting & Outsourcing Conference & Tabletop Exhibition will be held September 22-23, 2022 at Hyatt Regency New Brunswick, NJ, located in the heart of New Jersey’s pharmaceutical industry. The two-day conference and one-day exhibition on September 22nd providesthe
ORAL SOLIDS: MARKET & TECHNOLOGY TRENDS The global OSD pharmaceutical formulation market is forecasted to grow from $493 billion in 2017 to $926 billion by the end of 2027, according to Future Market Insights. This represents a compound annual growth rate (CAGR) of 6.5% over the 10-year forecast period. MANUFACTURING CONTROLLED DRUGS Manufacturing Controlled Drugs . Guidelines for manufacture & formulation of Schedule II drugs . By Scott Silaika. Aesica Pharmaceuticals . The manufacture of controlled drugs is a vital and necessary part of today’s pharmaceutical industry that looks set togrow
ENVIRONMENTAL MONITORING The development of an environmental monitoring strategy and policy is a basic first stage to maintaining control of an environment. Key questions are what specifications are required and where these specifications will most likely be challenged. Depending on the product, the specifications to manufacture may be predefined 1. THE TOP 50 BIOPHARMA PRODUCTS A list of the best-selling biopharma products from 2010 OVERCOMING THE TECH TRANSFER CHALLENGE Natraj Ram, Jennifer L. Bixler and Don R. Durham 08.22.05. T he effectiveness of technology transfer is one of the key determinants in the success of a contract-manufacturing project. In most cases, it is the biggest unknown with respect to timelines, cost and expertise DISTINGUISHING DEVICES FROM DRUGS John G. Moore, J.D., Ph.D. and Adele M. Kaplan Gilpin, J.D., Ph.D. 11.14.11. In June 2011, the Food and Drug Administration (FDA) published two companion draft guidance documents to assist industry and FDA staff in distinguishing medical devices from drugs. There has been a pressing need for guidance as the number of “drug-like”devices has
PHARMACEUTICAL AND BIOPHARMACEUTICAL CONTRACT SERVICING R&D Alliance for Eye Disease Cell Therapies. BlueRock Therapeutics, Fujifilm Cellular Dynamics, and Opsis Therapeutics enter R&D pact to discover and develop cell therapies for eye diseases. Tim Wright, Editor, Contract Pharma 05.17.21. PFIZER, BIONTECH TO PROVIDE 500M COVID VAX DOSES TO U.S 1 day ago · Pfizer Inc. and BioNTech SE plan to provide the U.S. government at a not-for-profit price 500 million doses of the companies’ COVID-19 vaccine, 200 million doses in 2021 and 300 million doses in 1H22. The government will, in turn, donate the Pfizer-BioNTech vaccine doses to low- and lower middle-income countries and organizations that support them. EXELEAD HELPS MANUFACTURE PFIZER-BIONTECH COVID-19 VACCINE Exelead, Inc., a contract development and manufacturing organization (CDMO) providing complex medicines to customers and their patients, delivered its first vaccine precursor batch manufactured at its facility, as part of an agreement with Pfizer for the Pfizer-BioNTech COVID-19 vaccine.In its recently expanded, state-of-the-art facilities, Exelead is supporting production of the AGC BIOLOGICS INKS SUPPLY DEAL FOR COVID-19 VACCINE AGC Biologics, a global biopharmaceutical contract development and manufacturing organization (CDMO), has partnered with BioNTech SE to supply Plasmid DNA (pDNA) starting material for the Pfizer-BioNTech COVID-19 vaccine, at AGC’s Heidelberg, Germany facility. “We are honored that BioNTech has entrusted us to become part of their global supply network in an effort to make the INOVIO, ADVACCINE EXPAND COVID VAX ALLIANCE INOVIO has expanded its partnership with Advaccine Biopharmaceuticals Suzhou Co., Ltd. to jointly conduct a global Phase 3 segment of the ongoing Phase 2/3 trial called INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy). The companies will evaluate the safety and efficacy of INO-4800 in a two-dose regimen (2.0 mg), administered one month apart, in a two-to-one randomization in subjects YOURWAY BREAKS GROUND ON MAJOR EXPANSION AT PENNSYLVANIA Yourway, a courier and packager in the clinical trials supply chain market, is expanding its headquarters in Allentown, PA, adding an additional 3,500 pallet locations of refrigerated 2-8°C space and increasing the footprint of the campus to over 300,000 square feet.When complete, the expansion will effectively double the primary and secondary packaging, storage, and distribution capabilities THE 2020 TOP 25 PHARMA AND BIOPHARMA COMPANIES Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies. You can obtain detailed information about the use of cookies on our website by clicking on "More information”. Got It PROCELL FOR PATIENT PROJECT TO DEVELOP AUTOMATED 1 day ago · The Robert-Bosch-Krankenhaus (RBK) in Stuttgart, the Universitätsklinikum Heidelberg and the Pharma Division of the Schwaebisch Hall-based special machine manufacturer Optima launched a project called "ProCell for Patient” that aims to develop a production system for CAR-T cell therapies. Every year, over 430,000 people worldwide are diagnosed with leukemia. FUSION TO BUILD RADIOPHARMA MANUFACTURING FACILITY Fusion Pharmaceuticals, a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, has entered a 15-year lease agreement with Hamilton, Ontario-based McMaster University to build a 27,000 square foot current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility. FDA APPROVES ADUCANUMAB TO TREAT ALZHEIMER’S DISEASE The U.S. Food and Drug Administration (FDA) has approved aducanumab, the first drug that slows Alzheimer's disease. Aducanumab is also the first novel therapy for Alzheimer’s disease approved since 2003. Biogen and its Japanese partner Eisai developed PHARMACEUTICAL AND BIOPHARMACEUTICAL CONTRACT SERVICINGANALYTICAL SERVICESBIOANALYTICAL SERVICESBIOASSAY DEVELOPEMENTBIOLOGICS,PROTEINS, VACCINES
R&D Alliance for Eye Disease Cell Therapies. BlueRock Therapeutics, Fujifilm Cellular Dynamics, and Opsis Therapeutics enter R&D pact to discover and develop cell therapies for eye diseases. Tim Wright, Editor, Contract Pharma 05.17.21.DRUG DELIVERY
Inhaled Drug Delivery Technology. The success of any new inhaled medicine relies in a large part on the correct combination of formulation and device technology being chosen for its delivery. Dr. Sandy Munro, Vice President – Pharmaceutical Development, Vectura01.27.21.
CONFERENCE CONTRACT PHARMA The Web Series will take place September 9 – 30, 2021. The 21st Annual Contracting & Outsourcing Conference & Tabletop Exhibition will be held September 22-23, 2022 at Hyatt Regency New Brunswick, NJ, located in the heart of New Jersey’s pharmaceutical industry. The two-day conference and one-day exhibition on September 22nd providesthe
NUTRACEUTICAL MANUFACTURING: MEETING THE CHALLENGES OF The arrival of COVID-19 in the U.S. last spring led to significant disruption of raw material supplies, which coincided with spikes in demand for health products, particularly dietary supplements positioned for immune support. MANUFACTURING CONTROLLED DRUGS Manufacturing Controlled Drugs . Guidelines for manufacture & formulation of Schedule II drugs . By Scott Silaika. Aesica Pharmaceuticals . The manufacture of controlled drugs is a vital and necessary part of today’s pharmaceutical industry that looks set togrow
WHAT TO LOOK FOR IN A CONTRACT MANUFACTURER The following are 11 items to look for in a contract manufacturer. Industry Certified. In this industry, there are a number of critical natural products certifications a company can attain. These certifications help customers and partners know they are compliant with stringent standards of quality. For example, Good ManufacturingPractices
PHARMACEUTICAL STERILITY TESTING Pharmaceutical Sterility Testing. Sterility testing of pharmaceutical articles is required during the sterilization validation process as well as for routine release testing. USP requirements employ sterility testing as an official test to determine suitability of a lot. An understanding of sterility testing is beneficial in terms of designing SIX STEPS TO QUALIFYING DISINFECTANTS The following six steps provide a framework to assist companies in qualifying the disinfectants used in their environmental cleaning processes. Whether performed internally or by an outside testing lab, they must be addressed. Step 1: Determine the Test Method. There are a number of methods for qualifying a disinfectant published by the SECONDARY USE OF HEALTHCARE DATA Facilitating the secondary use of healthcare data is a case in point. Secondary use involves the ability to access patient data from electronic health records (EHRs) and other sources for purposes such as clinical trials, or the monitoring of safety and efficacy following market release of a drug. Pharma companies obviously need such data in HEAVY METALS IN DRUG PRODUCTS Common metals used in this way include chromium, copper, nickel, palladium, platinum, rhodium and platinum, although there are others. Historically, the most likely culprits for trace metals in drug products were arsenic, cadmium, lead and mercury, all of which are much more likely to enter the manufacturing chain from naturalsources.
PHARMACEUTICAL AND BIOPHARMACEUTICAL CONTRACT SERVICINGANALYTICAL SERVICESBIOANALYTICAL SERVICESBIOASSAY DEVELOPEMENTBIOLOGICS,PROTEINS, VACCINES
R&D Alliance for Eye Disease Cell Therapies. BlueRock Therapeutics, Fujifilm Cellular Dynamics, and Opsis Therapeutics enter R&D pact to discover and develop cell therapies for eye diseases. Tim Wright, Editor, Contract Pharma 05.17.21.DRUG DELIVERY
Inhaled Drug Delivery Technology. The success of any new inhaled medicine relies in a large part on the correct combination of formulation and device technology being chosen for its delivery. Dr. Sandy Munro, Vice President – Pharmaceutical Development, Vectura01.27.21.
CONFERENCE CONTRACT PHARMA The Web Series will take place September 9 – 30, 2021. The 21st Annual Contracting & Outsourcing Conference & Tabletop Exhibition will be held September 22-23, 2022 at Hyatt Regency New Brunswick, NJ, located in the heart of New Jersey’s pharmaceutical industry. The two-day conference and one-day exhibition on September 22nd providesthe
NUTRACEUTICAL MANUFACTURING: MEETING THE CHALLENGES OF The arrival of COVID-19 in the U.S. last spring led to significant disruption of raw material supplies, which coincided with spikes in demand for health products, particularly dietary supplements positioned for immune support. MANUFACTURING CONTROLLED DRUGS Manufacturing Controlled Drugs . Guidelines for manufacture & formulation of Schedule II drugs . By Scott Silaika. Aesica Pharmaceuticals . The manufacture of controlled drugs is a vital and necessary part of today’s pharmaceutical industry that looks set togrow
WHAT TO LOOK FOR IN A CONTRACT MANUFACTURER The following are 11 items to look for in a contract manufacturer. Industry Certified. In this industry, there are a number of critical natural products certifications a company can attain. These certifications help customers and partners know they are compliant with stringent standards of quality. For example, Good ManufacturingPractices
PHARMACEUTICAL STERILITY TESTING Pharmaceutical Sterility Testing. Sterility testing of pharmaceutical articles is required during the sterilization validation process as well as for routine release testing. USP requirements employ sterility testing as an official test to determine suitability of a lot. An understanding of sterility testing is beneficial in terms of designing SIX STEPS TO QUALIFYING DISINFECTANTS The following six steps provide a framework to assist companies in qualifying the disinfectants used in their environmental cleaning processes. Whether performed internally or by an outside testing lab, they must be addressed. Step 1: Determine the Test Method. There are a number of methods for qualifying a disinfectant published by the SECONDARY USE OF HEALTHCARE DATA Facilitating the secondary use of healthcare data is a case in point. Secondary use involves the ability to access patient data from electronic health records (EHRs) and other sources for purposes such as clinical trials, or the monitoring of safety and efficacy following market release of a drug. Pharma companies obviously need such data in HEAVY METALS IN DRUG PRODUCTS Common metals used in this way include chromium, copper, nickel, palladium, platinum, rhodium and platinum, although there are others. Historically, the most likely culprits for trace metals in drug products were arsenic, cadmium, lead and mercury, all of which are much more likely to enter the manufacturing chain from naturalsources.
INOVIO, ADVACCINE EXPAND COVID VAX ALLIANCE INOVIO has expanded its partnership with Advaccine Biopharmaceuticals Suzhou Co., Ltd. to jointly conduct a global Phase 3 segment of the ongoing Phase 2/3 trial called INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy). The companies will evaluate the safety and efficacy of INO-4800 in a two-dose regimen (2.0 mg), administered one month apart, in a two-to-one randomization in subjects AGC BIOLOGICS INKS SUPPLY DEAL FOR COVID-19 VACCINE AGC Biologics, a global biopharmaceutical contract development and manufacturing organization (CDMO), has partnered with BioNTech SE to supply Plasmid DNA (pDNA) starting material for the Pfizer-BioNTech COVID-19 vaccine, at AGC’s Heidelberg, Germany facility. “We are honored that BioNTech has entrusted us to become part of their global supply network in an effort to make the EXELEAD HELPS MANUFACTURE PFIZER-BIONTECH COVID-19 VACCINE Exelead, Inc., a contract development and manufacturing organization (CDMO) providing complex medicines to customers and their patients, delivered its first vaccine precursor batch manufactured at its facility, as part of an agreement with Pfizer for the Pfizer-BioNTech COVID-19 vaccine.In its recently expanded, state-of-the-art facilities, Exelead is supporting production of the FUSION TO BUILD RADIOPHARMA MANUFACTURING FACILITY Fusion Pharmaceuticals, a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, has entered a 15-year lease agreement with Hamilton, Ontario-based McMaster University to build a 27,000 square foot current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility. YOURWAY BREAKS GROUND ON MAJOR EXPANSION AT PENNSYLVANIA 1 day ago · Yourway, a courier and packager in the clinical trials supply chain market, is expanding its headquarters in Allentown, PA, adding an additional 3,500 pallet locations of refrigerated 2-8°C space and increasing the footprint of the campus to over 300,000 square feet.When complete, the expansion will effectively double the primary and secondary packaging, storage, and distributioncapabilities
FDA APPROVES ADUCANUMAB TO TREAT ALZHEIMER’S DISEASE The U.S. Food and Drug Administration (FDA) has approved aducanumab, the first drug that slows Alzheimer's disease. Aducanumab is also the first novel therapy for Alzheimer’s disease approved since 2003. Biogen and its Japanese partner Eisai developed BIOCLINICA ADDS ECONSENT TO EDC PLATFORM Bioclinica, an ERT company, added eConsent as part of its Electronic Data Capture and Management suite of products. The new electronic module is built to support the entire consent process from document approval by IRBs to in-person or remote PORTONBIO ENTER CAR-T PARTNERSHIP WITH KAEDI Porton Biologics has entered a CAR-T partnership with Nanjing KAEDI Biotech. Portonbio will offer CMC services for KAEDI's CAR-T cell therapies with its end-to-end CDMO platform for gene and cell therapies to help accelerate their development process. JUBILANT HOLLISTERSTIER EXPANDS STERILE INJECTABLE MFG Jubilant HollisterStier is investing $92 million to expand sterile injectable manufacturing capacity at its site in Spokane, WA. The expansion includes the set up of a high-speed, 400 vials a minute, injectable fill line with isolator technology, which will add 50% capacity at the Spokane facility. AVANTOR ACQUIRES RIM BIO Avantor, Inc., a global provider of products and services to the life sciences and advanced technologies & applied materials industries, has acquired RIM Bio, a China-based manufacturer of single-use bioprocess bags and assemblies for biopharmaceutical manufacturing applications. RIM Bio’s Changzhou, China facility is Avantor’s first single-use production plant in the AMEA region, building PHARMACEUTICAL AND BIOPHARMACEUTICAL CONTRACT SERVICINGANALYTICAL SERVICESBIOANALYTICAL SERVICESBIOASSAY DEVELOPEMENTBIOLOGICS,PROTEINS, VACCINES
R&D Alliance for Eye Disease Cell Therapies. BlueRock Therapeutics, Fujifilm Cellular Dynamics, and Opsis Therapeutics enter R&D pact to discover and develop cell therapies for eye diseases. Tim Wright, Editor, Contract Pharma 05.17.21.DRUG DELIVERY
Inhaled Drug Delivery Technology. The success of any new inhaled medicine relies in a large part on the correct combination of formulation and device technology being chosen for its delivery. Dr. Sandy Munro, Vice President – Pharmaceutical Development, Vectura01.27.21.
NUTRACEUTICAL MANUFACTURING: MEETING THE CHALLENGES OF The arrival of COVID-19 in the U.S. last spring led to significant disruption of raw material supplies, which coincided with spikes in demand for health products, particularly dietary supplements positioned for immune support. CONFERENCE CONTRACT PHARMA The Web Series will take place September 9 – 30, 2021. The 21st Annual Contracting & Outsourcing Conference & Tabletop Exhibition will be held September 22-23, 2022 at Hyatt Regency New Brunswick, NJ, located in the heart of New Jersey’s pharmaceutical industry. The two-day conference and one-day exhibition on September 22nd providesthe
ORAL SOLIDS: MARKET & TECHNOLOGY TRENDS The global OSD pharmaceutical formulation market is forecasted to grow from $493 billion in 2017 to $926 billion by the end of 2027, according to Future Market Insights. This represents a compound annual growth rate (CAGR) of 6.5% over the 10-year forecast period. WHAT TO LOOK FOR IN A CONTRACT MANUFACTURER The following are 11 items to look for in a contract manufacturer. Industry Certified. In this industry, there are a number of critical natural products certifications a company can attain. These certifications help customers and partners know they are compliant with stringent standards of quality. For example, Good ManufacturingPractices
MANUFACTURING OF SOLID DOSAGE FORMS Manufacturing of Solid Dosage Forms. The trend towards outsourcing solid dose manufacturing has been driven by the ever more complex nature of new molecules. Innovators are choosing to share the burden of challenges relating to bioavailability, formulation, stability, manufacturability and, not to mention, scalability. MANUFACTURING CONTROLLED DRUGS Manufacturing Controlled Drugs . Guidelines for manufacture & formulation of Schedule II drugs . By Scott Silaika. Aesica Pharmaceuticals . The manufacture of controlled drugs is a vital and necessary part of today’s pharmaceutical industry that looks set togrow
ENVIRONMENTAL MONITORING The development of an environmental monitoring strategy and policy is a basic first stage to maintaining control of an environment. Key questions are what specifications are required and where these specifications will most likely be challenged. Depending on the product, the specifications to manufacture may be predefined 1. SECONDARY USE OF HEALTHCARE DATA Facilitating the secondary use of healthcare data is a case in point. Secondary use involves the ability to access patient data from electronic health records (EHRs) and other sources for purposes such as clinical trials, or the monitoring of safety and efficacy following market release of a drug. Pharma companies obviously need such data in PHARMACEUTICAL AND BIOPHARMACEUTICAL CONTRACT SERVICINGANALYTICAL SERVICESBIOANALYTICAL SERVICESBIOASSAY DEVELOPEMENTBIOLOGICS,PROTEINS, VACCINES
R&D Alliance for Eye Disease Cell Therapies. BlueRock Therapeutics, Fujifilm Cellular Dynamics, and Opsis Therapeutics enter R&D pact to discover and develop cell therapies for eye diseases. Tim Wright, Editor, Contract Pharma 05.17.21.DRUG DELIVERY
Inhaled Drug Delivery Technology. The success of any new inhaled medicine relies in a large part on the correct combination of formulation and device technology being chosen for its delivery. Dr. Sandy Munro, Vice President – Pharmaceutical Development, Vectura01.27.21.
NUTRACEUTICAL MANUFACTURING: MEETING THE CHALLENGES OF The arrival of COVID-19 in the U.S. last spring led to significant disruption of raw material supplies, which coincided with spikes in demand for health products, particularly dietary supplements positioned for immune support. CONFERENCE CONTRACT PHARMA The Web Series will take place September 9 – 30, 2021. The 21st Annual Contracting & Outsourcing Conference & Tabletop Exhibition will be held September 22-23, 2022 at Hyatt Regency New Brunswick, NJ, located in the heart of New Jersey’s pharmaceutical industry. The two-day conference and one-day exhibition on September 22nd providesthe
ORAL SOLIDS: MARKET & TECHNOLOGY TRENDS The global OSD pharmaceutical formulation market is forecasted to grow from $493 billion in 2017 to $926 billion by the end of 2027, according to Future Market Insights. This represents a compound annual growth rate (CAGR) of 6.5% over the 10-year forecast period. WHAT TO LOOK FOR IN A CONTRACT MANUFACTURER The following are 11 items to look for in a contract manufacturer. Industry Certified. In this industry, there are a number of critical natural products certifications a company can attain. These certifications help customers and partners know they are compliant with stringent standards of quality. For example, Good ManufacturingPractices
MANUFACTURING OF SOLID DOSAGE FORMS Manufacturing of Solid Dosage Forms. The trend towards outsourcing solid dose manufacturing has been driven by the ever more complex nature of new molecules. Innovators are choosing to share the burden of challenges relating to bioavailability, formulation, stability, manufacturability and, not to mention, scalability. MANUFACTURING CONTROLLED DRUGS Manufacturing Controlled Drugs . Guidelines for manufacture & formulation of Schedule II drugs . By Scott Silaika. Aesica Pharmaceuticals . The manufacture of controlled drugs is a vital and necessary part of today’s pharmaceutical industry that looks set togrow
ENVIRONMENTAL MONITORING The development of an environmental monitoring strategy and policy is a basic first stage to maintaining control of an environment. Key questions are what specifications are required and where these specifications will most likely be challenged. Depending on the product, the specifications to manufacture may be predefined 1. SECONDARY USE OF HEALTHCARE DATA Facilitating the secondary use of healthcare data is a case in point. Secondary use involves the ability to access patient data from electronic health records (EHRs) and other sources for purposes such as clinical trials, or the monitoring of safety and efficacy following market release of a drug. Pharma companies obviously need such data inCONTRACT PHARMA
Our Contract Services Directory contains listings for all of your outsourcing needs, covering manufacturing, packaging, formulation, clinical trials, equipment, ingredients and more! EXELEAD HELPS MANUFACTURE PFIZER-BIONTECH COVID-19 VACCINE Exelead, Inc., a contract development and manufacturing organization (CDMO) providing complex medicines to customers and their patients, delivered its first vaccine precursor batch manufactured at its facility, as part of an agreement with Pfizer for the Pfizer-BioNTech COVID-19 vaccine.In its recently expanded, state-of-the-art facilities, Exelead is supporting production of the FUSION TO BUILD RADIOPHARMA MANUFACTURING FACILITY Fusion Pharmaceuticals, a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, has entered a 15-year lease agreement with Hamilton, Ontario-based McMaster University to build a 27,000 square foot current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility. INOVIO, ADVACCINE EXPAND COVID VAX ALLIANCE 1 day ago · INOVIO has expanded its partnership with Advaccine Biopharmaceuticals Suzhou Co., Ltd. to jointly conduct a global Phase 3 segment of the ongoing Phase 2/3 trial called INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy). The companies will evaluate the safety and efficacy of INO-4800 in a two-dose regimen (2.0 mg), administered one month apart, in a two-to-one randomization insubjects
AGC BIOLOGICS INKS SUPPLY DEAL FOR COVID-19 VACCINE AGC Biologics, a global biopharmaceutical contract development and manufacturing organization (CDMO), has partnered with BioNTech SE to supply Plasmid DNA (pDNA) starting material for the Pfizer-BioNTech COVID-19 vaccine, at AGC’s Heidelberg, Germany facility. “We are honored that BioNTech has entrusted us to become part of their global supply network in an effort to make the FDA APPROVES ADUCANUMAB TO TREAT ALZHEIMER’S DISEASE 1 day ago · The U.S. Food and Drug Administration (FDA) has approved aducanumab, the first drug that slows Alzheimer's disease. Aducanumab is also the first novel therapy for Alzheimer’s disease approved since 2003. Biogen and its Japanese partner Eisai developed BIOCLINICA ADDS ECONSENT TO EDC PLATFORM 1 day ago · Bioclinica, an ERT company, added eConsent as part of its Electronic Data Capture and Management suite of products. The new electronic module is built to support the entire consent process from document approval by IRBs to in-person or remote PORTONBIO ENTER CAR-T PARTNERSHIP WITH KAEDI Porton Biologics has entered a CAR-T partnership with Nanjing KAEDI Biotech. Portonbio will offer CMC services for KAEDI's CAR-T cell therapies with its end-to-end CDMO platform for gene and cell therapies to help accelerate their development process. Portonbio, as an exclusive CDMO partner, will JUBILANT HOLLISTERSTIER EXPANDS STERILE INJECTABLE MFG Jubilant HollisterStier is investing $92 million to expand sterile injectable manufacturing capacity at its site in Spokane, WA. The expansion includes the set up of a high-speed, 400 vials a minute, injectable fill line with isolator technology, which will add 50% capacity at the Spokane facility. AVANTOR ACQUIRES RIM BIO Avantor, Inc., a global provider of products and services to the life sciences and advanced technologies & applied materials industries, has acquired RIM Bio, a China-based manufacturer of single-use bioprocess bags and assemblies for biopharmaceutical manufacturing applications. RIM Bio’s Changzhou, China facility is Avantor’s first single-use production plant in the AMEA region, building PHARMACEUTICAL AND BIOPHARMACEUTICAL CONTRACT SERVICINGANALYTICAL SERVICESBIOANALYTICAL SERVICESBIOASSAY DEVELOPEMENTBIOLOGICS,PROTEINS, VACCINES
R&D Alliance for Eye Disease Cell Therapies. BlueRock Therapeutics, Fujifilm Cellular Dynamics, and Opsis Therapeutics enter R&D pact to discover and develop cell therapies for eye diseases. Tim Wright, Editor, Contract Pharma 05.17.21. THE 2020 TOP 25 PHARMA AND BIOPHARMA COMPANIES Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies. You can obtain detailed information about the use of cookies on our website by clicking on "More information”. Got It NUTRACEUTICAL MANUFACTURING: MEETING THE CHALLENGES OF The arrival of COVID-19 in the U.S. last spring led to significant disruption of raw material supplies, which coincided with spikes in demand for health products, particularly dietary supplements positioned for immune support. CONFERENCE CONTRACT PHARMA The Web Series will take place September 9 – 30, 2021. The 21st Annual Contracting & Outsourcing Conference & Tabletop Exhibition will be held September 22-23, 2022 at Hyatt Regency New Brunswick, NJ, located in the heart of New Jersey’s pharmaceutical industry. The two-day conference and one-day exhibition on September 22nd providesthe
INJECTABLE DRUG DELIVERY TRENDS Parenteral products are a major growth engine in today’s surging global biopharma market. Figure 1 shows their share of the global market is expected to grow from 52% in 2019 ($604bn) to 55% in 2026 ($1,206bn), outpacing other routes of administration. 1 On average, more than 40% of the medications approved by the FDA are injectable,with
WHAT TO LOOK FOR IN A CONTRACT MANUFACTURER The following are 11 items to look for in a contract manufacturer. Industry Certified. In this industry, there are a number of critical natural products certifications a company can attain. These certifications help customers and partners know they are compliant with stringent standards of quality. For example, Good ManufacturingPractices
ENVIRONMENTAL MONITORING The development of an environmental monitoring strategy and policy is a basic first stage to maintaining control of an environment. Key questions are what specifications are required and where these specifications will most likely be challenged. Depending on the product, the specifications to manufacture may be predefined 1. OVERCOMING THE TECH TRANSFER CHALLENGE Natraj Ram, Jennifer L. Bixler and Don R. Durham 08.22.05. T he effectiveness of technology transfer is one of the key determinants in the success of a contract-manufacturing project. In most cases, it is the biggest unknown with respect to timelines, cost and expertise THE RISK MANAGEMENT OF TECH TRANSFER The technology transfer process is the framework of that risk assessment and risk management. The interval of technology transfer process can be defined as starting with the initial client/CMO meeting and ending with issuance of the cGMP record for execution. All of the activities that occur between those two points are meant to minimizerisk
MODELING & SIMULATION FOR DRUG DEVELOPMENT & FORMULATION Modeling and simulation (M&S) has already profoundly impacted drug development and formulation. It is used in 90% of all U.S. Food and Drug Administration (FDA) drug approvals. M&S can influence every phase of the drug development process, including informing commercial decisions about the benefits of bringing a specific drug to market. PHARMACEUTICAL AND BIOPHARMACEUTICAL CONTRACT SERVICINGANALYTICAL SERVICESBIOANALYTICAL SERVICESBIOASSAY DEVELOPEMENTBIOLOGICS,PROTEINS, VACCINES
R&D Alliance for Eye Disease Cell Therapies. BlueRock Therapeutics, Fujifilm Cellular Dynamics, and Opsis Therapeutics enter R&D pact to discover and develop cell therapies for eye diseases. Tim Wright, Editor, Contract Pharma 05.17.21. THE 2020 TOP 25 PHARMA AND BIOPHARMA COMPANIES Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies. You can obtain detailed information about the use of cookies on our website by clicking on "More information”. Got It NUTRACEUTICAL MANUFACTURING: MEETING THE CHALLENGES OF The arrival of COVID-19 in the U.S. last spring led to significant disruption of raw material supplies, which coincided with spikes in demand for health products, particularly dietary supplements positioned for immune support. CONFERENCE CONTRACT PHARMA The Web Series will take place September 9 – 30, 2021. The 21st Annual Contracting & Outsourcing Conference & Tabletop Exhibition will be held September 22-23, 2022 at Hyatt Regency New Brunswick, NJ, located in the heart of New Jersey’s pharmaceutical industry. The two-day conference and one-day exhibition on September 22nd providesthe
INJECTABLE DRUG DELIVERY TRENDS Parenteral products are a major growth engine in today’s surging global biopharma market. Figure 1 shows their share of the global market is expected to grow from 52% in 2019 ($604bn) to 55% in 2026 ($1,206bn), outpacing other routes of administration. 1 On average, more than 40% of the medications approved by the FDA are injectable,with
WHAT TO LOOK FOR IN A CONTRACT MANUFACTURER The following are 11 items to look for in a contract manufacturer. Industry Certified. In this industry, there are a number of critical natural products certifications a company can attain. These certifications help customers and partners know they are compliant with stringent standards of quality. For example, Good ManufacturingPractices
ENVIRONMENTAL MONITORING The development of an environmental monitoring strategy and policy is a basic first stage to maintaining control of an environment. Key questions are what specifications are required and where these specifications will most likely be challenged. Depending on the product, the specifications to manufacture may be predefined 1. OVERCOMING THE TECH TRANSFER CHALLENGE Natraj Ram, Jennifer L. Bixler and Don R. Durham 08.22.05. T he effectiveness of technology transfer is one of the key determinants in the success of a contract-manufacturing project. In most cases, it is the biggest unknown with respect to timelines, cost and expertise THE RISK MANAGEMENT OF TECH TRANSFER The technology transfer process is the framework of that risk assessment and risk management. The interval of technology transfer process can be defined as starting with the initial client/CMO meeting and ending with issuance of the cGMP record for execution. All of the activities that occur between those two points are meant to minimizerisk
MODELING & SIMULATION FOR DRUG DEVELOPMENT & FORMULATION Modeling and simulation (M&S) has already profoundly impacted drug development and formulation. It is used in 90% of all U.S. Food and Drug Administration (FDA) drug approvals. M&S can influence every phase of the drug development process, including informing commercial decisions about the benefits of bringing a specific drug to market. EXELEAD HELPS MANUFACTURE PFIZER-BIONTECH COVID-19 VACCINE Exelead, Inc., a contract development and manufacturing organization (CDMO) providing complex medicines to customers and their patients, delivered its first vaccine precursor batch manufactured at its facility, as part of an agreement with Pfizer for the Pfizer-BioNTech COVID-19 vaccine.In its recently expanded, state-of-the-art facilities, Exelead is supporting production of the AGC BIOLOGICS INKS SUPPLY DEAL FOR COVID-19 VACCINE AGC Biologics, a global biopharmaceutical contract development and manufacturing organization (CDMO), has partnered with BioNTech SE to supply Plasmid DNA (pDNA) starting material for the Pfizer-BioNTech COVID-19 vaccine, at AGC’s Heidelberg, Germany facility. “We are honored that BioNTech has entrusted us to become part of their global supply network in an effort to make the INOVIO, ADVACCINE EXPAND COVID VAX ALLIANCE 1 day ago · INOVIO has expanded its partnership with Advaccine Biopharmaceuticals Suzhou Co., Ltd. to jointly conduct a global Phase 3 segment of the ongoing Phase 2/3 trial called INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy). The companies will evaluate the safety and efficacy of INO-4800 in a two-dose regimen (2.0 mg), administered one month apart, in a two-to-one randomization insubjects
PACKAGING - CONTRACT PHARMA Packaging - From primary to secondary packaging, Contract Pharma covers the latest market and technology trends as the demand for contact packaging services continues to grow. PORTONBIO ENTER CAR-T PARTNERSHIP WITH KAEDI Porton Biologics has entered a CAR-T partnership with Nanjing KAEDI Biotech. Portonbio will offer CMC services for KAEDI's CAR-T cell therapies with its end-to-end CDMO platform for gene and cell therapies to help accelerate their development process. Portonbio, as an exclusive CDMO partner, will FDA APPROVES ADUCANUMAB TO TREAT ALZHEIMER’S DISEASE 1 day ago · The U.S. Food and Drug Administration (FDA) has approved aducanumab, the first drug that slows Alzheimer's disease. Aducanumab is also the first novel therapy for Alzheimer’s disease approved since 2003. Biogen and its Japanese partner Eisai developed BIOCLINICA ADDS ECONSENT TO EDC PLATFORM 1 day ago · Bioclinica, an ERT company, added eConsent as part of its Electronic Data Capture and Management suite of products. The new electronic module is built to support the entire consent process from document approval by IRBs to in-person or remote JUBILANT HOLLISTERSTIER EXPANDS STERILE INJECTABLE MFG Jubilant HollisterStier is investing $92 million to expand sterile injectable manufacturing capacity at its site in Spokane, WA. The expansion includes the set up of a high-speed, 400 vials a minute, injectable fill line with isolator technology, which will add 50% capacity at the Spokane facility.REGULATORY AFFAIRS
Regulatory Affairs - Our Contract Services Directory contains listings for all of your outsourcing needs, covering manufacturing, packaging, formulation, clinical trials, AVANTOR ACQUIRES RIM BIO Avantor, Inc., a global provider of products and services to the life sciences and advanced technologies & applied materials industries, has acquired RIM Bio, a China-based manufacturer of single-use bioprocess bags and assemblies for biopharmaceutical manufacturing applications. RIM Bio’s Changzhou, China facility is Avantor’s first single-use production plant in the AMEA region, building PHARMACEUTICAL AND BIOPHARMACEUTICAL CONTRACT SERVICINGANALYTICAL SERVICESBIOANALYTICAL SERVICESBIOASSAY DEVELOPEMENTBIOLOGICS,PROTEINS, VACCINES
R&D Alliance for Eye Disease Cell Therapies. BlueRock Therapeutics, Fujifilm Cellular Dynamics, and Opsis Therapeutics enter R&D pact to discover and develop cell therapies for eye diseases. Tim Wright, Editor, Contract Pharma 05.17.21. THE 2020 TOP 25 PHARMA AND BIOPHARMA COMPANIES Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies. You can obtain detailed information about the use of cookies on our website by clicking on "More information”. Got It NUTRACEUTICAL MANUFACTURING: MEETING THE CHALLENGES OF The arrival of COVID-19 in the U.S. last spring led to significant disruption of raw material supplies, which coincided with spikes in demand for health products, particularly dietary supplements positioned for immune support. CONFERENCE CONTRACT PHARMA The Web Series will take place September 9 – 30, 2021. The 21st Annual Contracting & Outsourcing Conference & Tabletop Exhibition will be held September 22-23, 2022 at Hyatt Regency New Brunswick, NJ, located in the heart of New Jersey’s pharmaceutical industry. The two-day conference and one-day exhibition on September 22nd providesthe
INJECTABLE DRUG DELIVERY TRENDS Parenteral products are a major growth engine in today’s surging global biopharma market. Figure 1 shows their share of the global market is expected to grow from 52% in 2019 ($604bn) to 55% in 2026 ($1,206bn), outpacing other routes of administration. 1 On average, more than 40% of the medications approved by the FDA are injectable,with
WHAT TO LOOK FOR IN A CONTRACT MANUFACTURER The following are 11 items to look for in a contract manufacturer. Industry Certified. In this industry, there are a number of critical natural products certifications a company can attain. These certifications help customers and partners know they are compliant with stringent standards of quality. For example, Good ManufacturingPractices
ENVIRONMENTAL MONITORING The development of an environmental monitoring strategy and policy is a basic first stage to maintaining control of an environment. Key questions are what specifications are required and where these specifications will most likely be challenged. Depending on the product, the specifications to manufacture may be predefined 1. OVERCOMING THE TECH TRANSFER CHALLENGE Natraj Ram, Jennifer L. Bixler and Don R. Durham 08.22.05. T he effectiveness of technology transfer is one of the key determinants in the success of a contract-manufacturing project. In most cases, it is the biggest unknown with respect to timelines, cost and expertise THE RISK MANAGEMENT OF TECH TRANSFER The technology transfer process is the framework of that risk assessment and risk management. The interval of technology transfer process can be defined as starting with the initial client/CMO meeting and ending with issuance of the cGMP record for execution. All of the activities that occur between those two points are meant to minimizerisk
MODELING & SIMULATION FOR DRUG DEVELOPMENT & FORMULATION Modeling and simulation (M&S) has already profoundly impacted drug development and formulation. It is used in 90% of all U.S. Food and Drug Administration (FDA) drug approvals. M&S can influence every phase of the drug development process, including informing commercial decisions about the benefits of bringing a specific drug to market. PHARMACEUTICAL AND BIOPHARMACEUTICAL CONTRACT SERVICINGANALYTICAL SERVICESBIOANALYTICAL SERVICESBIOASSAY DEVELOPEMENTBIOLOGICS,PROTEINS, VACCINES
R&D Alliance for Eye Disease Cell Therapies. BlueRock Therapeutics, Fujifilm Cellular Dynamics, and Opsis Therapeutics enter R&D pact to discover and develop cell therapies for eye diseases. Tim Wright, Editor, Contract Pharma 05.17.21. THE 2020 TOP 25 PHARMA AND BIOPHARMA COMPANIES Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies. You can obtain detailed information about the use of cookies on our website by clicking on "More information”. Got It NUTRACEUTICAL MANUFACTURING: MEETING THE CHALLENGES OF The arrival of COVID-19 in the U.S. last spring led to significant disruption of raw material supplies, which coincided with spikes in demand for health products, particularly dietary supplements positioned for immune support. CONFERENCE CONTRACT PHARMA The Web Series will take place September 9 – 30, 2021. The 21st Annual Contracting & Outsourcing Conference & Tabletop Exhibition will be held September 22-23, 2022 at Hyatt Regency New Brunswick, NJ, located in the heart of New Jersey’s pharmaceutical industry. The two-day conference and one-day exhibition on September 22nd providesthe
INJECTABLE DRUG DELIVERY TRENDS Parenteral products are a major growth engine in today’s surging global biopharma market. Figure 1 shows their share of the global market is expected to grow from 52% in 2019 ($604bn) to 55% in 2026 ($1,206bn), outpacing other routes of administration. 1 On average, more than 40% of the medications approved by the FDA are injectable,with
WHAT TO LOOK FOR IN A CONTRACT MANUFACTURER The following are 11 items to look for in a contract manufacturer. Industry Certified. In this industry, there are a number of critical natural products certifications a company can attain. These certifications help customers and partners know they are compliant with stringent standards of quality. For example, Good ManufacturingPractices
ENVIRONMENTAL MONITORING The development of an environmental monitoring strategy and policy is a basic first stage to maintaining control of an environment. Key questions are what specifications are required and where these specifications will most likely be challenged. Depending on the product, the specifications to manufacture may be predefined 1. OVERCOMING THE TECH TRANSFER CHALLENGE Natraj Ram, Jennifer L. Bixler and Don R. Durham 08.22.05. T he effectiveness of technology transfer is one of the key determinants in the success of a contract-manufacturing project. In most cases, it is the biggest unknown with respect to timelines, cost and expertise THE RISK MANAGEMENT OF TECH TRANSFER The technology transfer process is the framework of that risk assessment and risk management. The interval of technology transfer process can be defined as starting with the initial client/CMO meeting and ending with issuance of the cGMP record for execution. All of the activities that occur between those two points are meant to minimizerisk
MODELING & SIMULATION FOR DRUG DEVELOPMENT & FORMULATION Modeling and simulation (M&S) has already profoundly impacted drug development and formulation. It is used in 90% of all U.S. Food and Drug Administration (FDA) drug approvals. M&S can influence every phase of the drug development process, including informing commercial decisions about the benefits of bringing a specific drug to market. INOVIO, ADVACCINE EXPAND COVID VAX ALLIANCE 1 day ago · INOVIO has expanded its partnership with Advaccine Biopharmaceuticals Suzhou Co., Ltd. to jointly conduct a global Phase 3 segment of the ongoing Phase 2/3 trial called INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy). The companies will evaluate the safety and efficacy of INO-4800 in a two-dose regimen (2.0 mg), administered one month apart, in a two-to-one randomization insubjects
EXELEAD HELPS MANUFACTURE PFIZER-BIONTECH COVID-19 VACCINE Exelead, Inc., a contract development and manufacturing organization (CDMO) providing complex medicines to customers and their patients, delivered its first vaccine precursor batch manufactured at its facility, as part of an agreement with Pfizer for the Pfizer-BioNTech COVID-19 vaccine.In its recently expanded, state-of-the-art facilities, Exelead is supporting production of the AGC BIOLOGICS INKS SUPPLY DEAL FOR COVID-19 VACCINE AGC Biologics, a global biopharmaceutical contract development and manufacturing organization (CDMO), has partnered with BioNTech SE to supply Plasmid DNA (pDNA) starting material for the Pfizer-BioNTech COVID-19 vaccine, at AGC’s Heidelberg, Germany facility. “We are honored that BioNTech has entrusted us to become part of their global supply network in an effort to make the LONZA, MODERNA EXPAND COVID VAX MFG. ALLIANCE Lonza expanded its collaboration with Moderna for the manufacture of the drug substance for Moderna’s COVID-19 Vaccine and provides for the installation of a new manufacturing line for drug substance production at Lonza’s Geleen (NL) site. The new production line in Geleen will complement Lonza’s existing drug substance production network for the COVID-19 Vaccine and deliver a crucial PACKAGING - CONTRACT PHARMA Packaging - From primary to secondary packaging, Contract Pharma covers the latest market and technology trends as the demand for contact packaging services continues to grow. FDA APPROVES ADUCANUMAB TO TREAT ALZHEIMER’S DISEASE 1 day ago · The U.S. Food and Drug Administration (FDA) has approved aducanumab, the first drug that slows Alzheimer's disease. Aducanumab is also the first novel therapy for Alzheimer’s disease approved since 2003. Biogen and its Japanese partner Eisai developed BIOCLINICA ADDS ECONSENT TO EDC PLATFORM 1 day ago · Bioclinica, an ERT company, added eConsent as part of its Electronic Data Capture and Management suite of products. The new electronic module is built to support the entire consent process from document approval by IRBs to in-person or remote PORTONBIO ENTER CAR-T PARTNERSHIP WITH KAEDI Porton Biologics has entered a CAR-T partnership with Nanjing KAEDI Biotech. Portonbio will offer CMC services for KAEDI's CAR-T cell therapies with its end-to-end CDMO platform for gene and cell therapies to help accelerate their development process. Portonbio, as an exclusive CDMO partner, will JUBILANT HOLLISTERSTIER EXPANDS STERILE INJECTABLE MFG Jubilant HollisterStier is investing $92 million to expand sterile injectable manufacturing capacity at its site in Spokane, WA. The expansion includes the set up of a high-speed, 400 vials a minute, injectable fill line with isolator technology, which will add 50% capacity at the Spokane facility.REGULATORY AFFAIRS
Regulatory Affairs - Our Contract Services Directory contains listings for all of your outsourcing needs, covering manufacturing, packaging, formulation, clinical trials, PHARMACEUTICAL AND BIOPHARMACEUTICAL CONTRACT SERVICINGANALYTICAL SERVICESBIOANALYTICAL SERVICESBIOASSAY DEVELOPEMENTBIOLOGICS,PROTEINS, VACCINES
R&D Alliance for Eye Disease Cell Therapies. BlueRock Therapeutics, Fujifilm Cellular Dynamics, and Opsis Therapeutics enter R&D pact to discover and develop cell therapies for eye diseases. Tim Wright, Editor, Contract Pharma 05.17.21. CONFERENCE CONTRACT PHARMAEXHIBITORS2019 SPEAKERSSPONSORSHOTELPHOTOSAGENDA The Web Series will take place September 9 – 30, 2021. The 21st Annual Contracting & Outsourcing Conference & Tabletop Exhibition will be held September 22-23, 2022 at Hyatt Regency New Brunswick, NJ, located in the heart of New Jersey’s pharmaceutical industry. The two-day conference and one-day exhibition on September 22nd providesthe
ENVIRONMENTAL MONITORING The development of an environmental monitoring strategy and policy is a basic first stage to maintaining control of an environment. Key questions are what specifications are required and where these specifications will most likely be challenged. Depending on the product, the specifications to manufacture may be predefined 1. AUTOMATION IN PHARMACEUTICAL MANUFACTURING Automation and other manufacturing systems, such as MES, have the potential to transform processes within pharmaceutical manufacturing facilities, opening the door to fundamental performance improvements. For manufacturers that fail to leverage these technologies, the introduction of new pharmaceutical products may take months or yearsrather
NITROSAMINES
Nitrosamines are a family of carcinogens which are formed by the reaction of secondary amines, amides, carbamates, derivatives of urea with nitrite or other nitrogenous agents with the nitrogen in the +3 state. 1 The common nature of the precursors and the facile nature of the nitrosation reactions under acidic pH have made nitrosamines one of the common and unwelcome guests in the world ofCDMOS ON THE RISE
Adding the sales estimates of the contract development manufacturing organizations (CDMOs) and contract research organizations (CROs) results in a market size greater than $120 billion, but it is likely far from reflecting its full potential. For 2017, the contract manufacturing market alone is estimated at about $70-75 billionincluding
HEAVY METALS IN DRUG PRODUCTS Common metals used in this way include chromium, copper, nickel, palladium, platinum, rhodium and platinum, although there are others. Historically, the most likely culprits for trace metals in drug products were arsenic, cadmium, lead and mercury, all of which are much more likely to enter the manufacturing chain from naturalsources.
CLINICAL TRIAL SUPPLIES PLANNING AND MANAGEMENT Efficient planning and management of clinical supplies can be challenging for trial sponsors, especially those with smaller internal teams or fewer resources. Challenges can include understanding and managing the increased pressure from government regulators, like the U.S. FDA and the European Medicines Agency (EMA), on qualityrequirements
MODELING & SIMULATION FOR DRUG DEVELOPMENT & FORMULATION3D SIMULATION SOFTWAREAPPLICATION SIMULATION SOFTWARECHEMICAL SIMULATION SOFTWAREFREE SIMULATION SOFTWARESIMULATION SOFTWARE COMPARISONSOFTWARE SIMULATION TOOLS FOR TRAINING Modeling and simulation (M&S) has already profoundly impacted drug development and formulation. It is used in 90% of all U.S. Food and Drug Administration (FDA) drug approvals. M&S can influence every phase of the drug development process, including informing commercial decisions about the benefits of bringing a specific drug to market. THE RISK MANAGEMENT OF TECH TRANSFER The technology transfer process is the framework of that risk assessment and risk management. The interval of technology transfer process can be defined as starting with the initial client/CMO meeting and ending with issuance of the cGMP record for execution. All of the activities that occur between those two points are meant to minimizerisk
PHARMACEUTICAL AND BIOPHARMACEUTICAL CONTRACT SERVICINGANALYTICAL SERVICESBIOANALYTICAL SERVICESBIOASSAY DEVELOPEMENTBIOLOGICS,PROTEINS, VACCINES
R&D Alliance for Eye Disease Cell Therapies. BlueRock Therapeutics, Fujifilm Cellular Dynamics, and Opsis Therapeutics enter R&D pact to discover and develop cell therapies for eye diseases. Tim Wright, Editor, Contract Pharma 05.17.21. CONFERENCE CONTRACT PHARMAEXHIBITORS2019 SPEAKERSSPONSORSHOTELPHOTOSAGENDA The Web Series will take place September 9 – 30, 2021. The 21st Annual Contracting & Outsourcing Conference & Tabletop Exhibition will be held September 22-23, 2022 at Hyatt Regency New Brunswick, NJ, located in the heart of New Jersey’s pharmaceutical industry. The two-day conference and one-day exhibition on September 22nd providesthe
ENVIRONMENTAL MONITORING The development of an environmental monitoring strategy and policy is a basic first stage to maintaining control of an environment. Key questions are what specifications are required and where these specifications will most likely be challenged. Depending on the product, the specifications to manufacture may be predefined 1. AUTOMATION IN PHARMACEUTICAL MANUFACTURING Automation and other manufacturing systems, such as MES, have the potential to transform processes within pharmaceutical manufacturing facilities, opening the door to fundamental performance improvements. For manufacturers that fail to leverage these technologies, the introduction of new pharmaceutical products may take months or yearsrather
NITROSAMINES
Nitrosamines are a family of carcinogens which are formed by the reaction of secondary amines, amides, carbamates, derivatives of urea with nitrite or other nitrogenous agents with the nitrogen in the +3 state. 1 The common nature of the precursors and the facile nature of the nitrosation reactions under acidic pH have made nitrosamines one of the common and unwelcome guests in the world ofCDMOS ON THE RISE
Adding the sales estimates of the contract development manufacturing organizations (CDMOs) and contract research organizations (CROs) results in a market size greater than $120 billion, but it is likely far from reflecting its full potential. For 2017, the contract manufacturing market alone is estimated at about $70-75 billionincluding
HEAVY METALS IN DRUG PRODUCTS Common metals used in this way include chromium, copper, nickel, palladium, platinum, rhodium and platinum, although there are others. Historically, the most likely culprits for trace metals in drug products were arsenic, cadmium, lead and mercury, all of which are much more likely to enter the manufacturing chain from naturalsources.
CLINICAL TRIAL SUPPLIES PLANNING AND MANAGEMENT Efficient planning and management of clinical supplies can be challenging for trial sponsors, especially those with smaller internal teams or fewer resources. Challenges can include understanding and managing the increased pressure from government regulators, like the U.S. FDA and the European Medicines Agency (EMA), on qualityrequirements
MODELING & SIMULATION FOR DRUG DEVELOPMENT & FORMULATION3D SIMULATION SOFTWAREAPPLICATION SIMULATION SOFTWARECHEMICAL SIMULATION SOFTWAREFREE SIMULATION SOFTWARESIMULATION SOFTWARE COMPARISONSOFTWARE SIMULATION TOOLS FOR TRAINING Modeling and simulation (M&S) has already profoundly impacted drug development and formulation. It is used in 90% of all U.S. Food and Drug Administration (FDA) drug approvals. M&S can influence every phase of the drug development process, including informing commercial decisions about the benefits of bringing a specific drug to market. THE RISK MANAGEMENT OF TECH TRANSFER The technology transfer process is the framework of that risk assessment and risk management. The interval of technology transfer process can be defined as starting with the initial client/CMO meeting and ending with issuance of the cGMP record for execution. All of the activities that occur between those two points are meant to minimizerisk
EXELEAD HELPS MANUFACTURE PFIZER-BIONTECH COVID-19 VACCINE 19 hours ago · Exelead, Inc., a contract development and manufacturing organization (CDMO) providing complex medicines to customers and their patients, delivered its first vaccine precursor batch manufactured at its facility, as part of an agreement with Pfizer for the Pfizer-BioNTech COVID-19 vaccine.In its recently expanded, state-of-the-art facilities, Exelead is supportingproduction of the
LONZA, MODERNA EXPAND COVID VAX MFG. ALLIANCE Lonza expanded its collaboration with Moderna for the manufacture of the drug substance for Moderna’s COVID-19 Vaccine and provides for the installation of a new manufacturing line for drug substance production at Lonza’s Geleen (NL) site. The new production line in Geleen will complement Lonza’s existing drug substance production network for the COVID-19 Vaccine and deliver a crucial JUBILANT HOLLISTERSTIER EXPANDS STERILE INJECTABLE MFG Jubilant HollisterStier is investing $92 million to expand sterile injectable manufacturing capacity at its site in Spokane, WA. The expansion includes the set up of a high-speed, 400 vials a minute, injectable fill line with isolator technology, which will add 50% capacity at the Spokane facility. PHARMABLOCK SCIENCES PARTNERS WITH SHOUYAO HOLDINGS PharmaBlock Sciences (Nanjing) Inc., an innovative chemistry products and services provider throughout the pharmaceutical R&D process and commercialization, and Shouyao Holdings Co., Ltd., a biopharmaceutical company focusing on innovative tumor and diabetes drug development, have entered a strategic partnership for the CMC development and manufacturing of Shouyao’s leading BIOVECTRA INC. UNVEILS NEW LOGO AND BRAND Biovectra Inc., a global contract development and manufacturing organization, has launched a new logo and brand to align with the growing company’s full suite of expertise and core values. “Over the last few years, we have grown significantly in size and added new capabilities, like our fully-operational large-scale biomanufacturing facility in Windsor, Nova Scotia,” said Biovectra chief DRIVING EFFICIENCIES IN TODAY’S COMPLEX TRIALS Murray Aitken is the executive director of the IQVIA Institute for Human Data Science. Mr. Aitken is a renowned expert on the challenges facing the global healthcare industry, and the prospects for improving patient outcomes through managing costs and THE FUTURE OF CONTINUOUS BIOPROCESSING Dr. Karoline Hahn is a Senior Consultant for Advanced Therapies on KCR’s Trial Execution Consulting team with 20 years of experience in the biopharmaceutical industry, devising regulatory strategies and leading interactions with global health authorities. A geneticist by training, Dr. Hahn has extensive expertise in Advanced Therapies and provides top-tier strategic regulatory services in ADARE PHARMA EXPANDS EXECUTIVE LEADERSHIP TEAM Adare Pharma Solutions has strengthened its executive leadership team with two key hires. Robert Muschert has joined Adare as Chief Commercial Officer, and Dr. Vipan Dhall has joined as Chief Scientific Officer. These key additions aim to further advance Adare’s position as a technology driven ONYX SCIENTIFIC RECEIVES COMMERCIAL API LICENSE FOR UK Onyx Scientific, a small molecule API contract development and manufacturing organization has received a commercial API license for its UK facility. The license, granted by the Medicines and Healthcare Products Regulatory Agency (MHRA), allows Onyx to support API projects from pre-clinical studies to low volume commercial manufacture. NEWSMAKERS: LYNN ALLEN, VICE PRESIDENT OF BUSINESS For the past 20 years, MedPharm has been helping clients navigate the complexities of topical and transdermal drug delivery. In fact, MedPharm was the first company to achieve European approval of topical generic products with in vitro bioequivalence testing only. MedPharm has established a strong worldwide reputation as product development experts in topical and transdermal delivery PHARMACEUTICAL AND BIOPHARMACEUTICAL CONTRACT SERVICINGANALYTICAL SERVICESBIOANALYTICAL SERVICESBIOASSAY DEVELOPEMENTBIOLOGICS,PROTEINS, VACCINES
R&D Alliance for Eye Disease Cell Therapies. BlueRock Therapeutics, Fujifilm Cellular Dynamics, and Opsis Therapeutics enter R&D pact to discover and develop cell therapies for eye diseases. Tim Wright, Editor, Contract Pharma 05.17.21. CONFERENCE CONTRACT PHARMAEXHIBITORS2019 SPEAKERSSPONSORSHOTELPHOTOSAGENDA The Web Series will take place September 9 – 30, 2021. The 21st Annual Contracting & Outsourcing Conference & Tabletop Exhibition will be held September 22-23, 2022 at Hyatt Regency New Brunswick, NJ, located in the heart of New Jersey’s pharmaceutical industry. The two-day conference and one-day exhibition on September 22nd providesthe
ENVIRONMENTAL MONITORING The development of an environmental monitoring strategy and policy is a basic first stage to maintaining control of an environment. Key questions are what specifications are required and where these specifications will most likely be challenged. Depending on the product, the specifications to manufacture may be predefined 1. AUTOMATION IN PHARMACEUTICAL MANUFACTURING Automation and other manufacturing systems, such as MES, have the potential to transform processes within pharmaceutical manufacturing facilities, opening the door to fundamental performance improvements. For manufacturers that fail to leverage these technologies, the introduction of new pharmaceutical products may take months or yearsrather
NITROSAMINES
Nitrosamines are a family of carcinogens which are formed by the reaction of secondary amines, amides, carbamates, derivatives of urea with nitrite or other nitrogenous agents with the nitrogen in the +3 state. 1 The common nature of the precursors and the facile nature of the nitrosation reactions under acidic pH have made nitrosamines one of the common and unwelcome guests in the world ofCDMOS ON THE RISE
Adding the sales estimates of the contract development manufacturing organizations (CDMOs) and contract research organizations (CROs) results in a market size greater than $120 billion, but it is likely far from reflecting its full potential. For 2017, the contract manufacturing market alone is estimated at about $70-75 billionincluding
HEAVY METALS IN DRUG PRODUCTS Common metals used in this way include chromium, copper, nickel, palladium, platinum, rhodium and platinum, although there are others. Historically, the most likely culprits for trace metals in drug products were arsenic, cadmium, lead and mercury, all of which are much more likely to enter the manufacturing chain from naturalsources.
CLINICAL TRIAL SUPPLIES PLANNING AND MANAGEMENT Efficient planning and management of clinical supplies can be challenging for trial sponsors, especially those with smaller internal teams or fewer resources. Challenges can include understanding and managing the increased pressure from government regulators, like the U.S. FDA and the European Medicines Agency (EMA), on qualityrequirements
MODELING & SIMULATION FOR DRUG DEVELOPMENT & FORMULATION3D SIMULATION SOFTWAREAPPLICATION SIMULATION SOFTWARECHEMICAL SIMULATION SOFTWAREFREE SIMULATION SOFTWARESIMULATION SOFTWARE COMPARISONSOFTWARE SIMULATION TOOLS FOR TRAINING Modeling and simulation (M&S) has already profoundly impacted drug development and formulation. It is used in 90% of all U.S. Food and Drug Administration (FDA) drug approvals. M&S can influence every phase of the drug development process, including informing commercial decisions about the benefits of bringing a specific drug to market. THE RISK MANAGEMENT OF TECH TRANSFER The technology transfer process is the framework of that risk assessment and risk management. The interval of technology transfer process can be defined as starting with the initial client/CMO meeting and ending with issuance of the cGMP record for execution. All of the activities that occur between those two points are meant to minimizerisk
PHARMACEUTICAL AND BIOPHARMACEUTICAL CONTRACT SERVICINGANALYTICAL SERVICESBIOANALYTICAL SERVICESBIOASSAY DEVELOPEMENTBIOLOGICS,PROTEINS, VACCINES
R&D Alliance for Eye Disease Cell Therapies. BlueRock Therapeutics, Fujifilm Cellular Dynamics, and Opsis Therapeutics enter R&D pact to discover and develop cell therapies for eye diseases. Tim Wright, Editor, Contract Pharma 05.17.21. CONFERENCE CONTRACT PHARMAEXHIBITORS2019 SPEAKERSSPONSORSHOTELPHOTOSAGENDA The Web Series will take place September 9 – 30, 2021. The 21st Annual Contracting & Outsourcing Conference & Tabletop Exhibition will be held September 22-23, 2022 at Hyatt Regency New Brunswick, NJ, located in the heart of New Jersey’s pharmaceutical industry. The two-day conference and one-day exhibition on September 22nd providesthe
ENVIRONMENTAL MONITORING The development of an environmental monitoring strategy and policy is a basic first stage to maintaining control of an environment. Key questions are what specifications are required and where these specifications will most likely be challenged. Depending on the product, the specifications to manufacture may be predefined 1. AUTOMATION IN PHARMACEUTICAL MANUFACTURING Automation and other manufacturing systems, such as MES, have the potential to transform processes within pharmaceutical manufacturing facilities, opening the door to fundamental performance improvements. For manufacturers that fail to leverage these technologies, the introduction of new pharmaceutical products may take months or yearsrather
NITROSAMINES
Nitrosamines are a family of carcinogens which are formed by the reaction of secondary amines, amides, carbamates, derivatives of urea with nitrite or other nitrogenous agents with the nitrogen in the +3 state. 1 The common nature of the precursors and the facile nature of the nitrosation reactions under acidic pH have made nitrosamines one of the common and unwelcome guests in the world ofCDMOS ON THE RISE
Adding the sales estimates of the contract development manufacturing organizations (CDMOs) and contract research organizations (CROs) results in a market size greater than $120 billion, but it is likely far from reflecting its full potential. For 2017, the contract manufacturing market alone is estimated at about $70-75 billionincluding
HEAVY METALS IN DRUG PRODUCTS Common metals used in this way include chromium, copper, nickel, palladium, platinum, rhodium and platinum, although there are others. Historically, the most likely culprits for trace metals in drug products were arsenic, cadmium, lead and mercury, all of which are much more likely to enter the manufacturing chain from naturalsources.
CLINICAL TRIAL SUPPLIES PLANNING AND MANAGEMENT Efficient planning and management of clinical supplies can be challenging for trial sponsors, especially those with smaller internal teams or fewer resources. Challenges can include understanding and managing the increased pressure from government regulators, like the U.S. FDA and the European Medicines Agency (EMA), on qualityrequirements
MODELING & SIMULATION FOR DRUG DEVELOPMENT & FORMULATION3D SIMULATION SOFTWAREAPPLICATION SIMULATION SOFTWARECHEMICAL SIMULATION SOFTWAREFREE SIMULATION SOFTWARESIMULATION SOFTWARE COMPARISONSOFTWARE SIMULATION TOOLS FOR TRAINING Modeling and simulation (M&S) has already profoundly impacted drug development and formulation. It is used in 90% of all U.S. Food and Drug Administration (FDA) drug approvals. M&S can influence every phase of the drug development process, including informing commercial decisions about the benefits of bringing a specific drug to market. THE RISK MANAGEMENT OF TECH TRANSFER The technology transfer process is the framework of that risk assessment and risk management. The interval of technology transfer process can be defined as starting with the initial client/CMO meeting and ending with issuance of the cGMP record for execution. All of the activities that occur between those two points are meant to minimizerisk
EXELEAD HELPS MANUFACTURE PFIZER-BIONTECH COVID-19 VACCINE 19 hours ago · Exelead, Inc., a contract development and manufacturing organization (CDMO) providing complex medicines to customers and their patients, delivered its first vaccine precursor batch manufactured at its facility, as part of an agreement with Pfizer for the Pfizer-BioNTech COVID-19 vaccine.In its recently expanded, state-of-the-art facilities, Exelead is supportingproduction of the
LONZA, MODERNA EXPAND COVID VAX MFG. ALLIANCE Lonza expanded its collaboration with Moderna for the manufacture of the drug substance for Moderna’s COVID-19 Vaccine and provides for the installation of a new manufacturing line for drug substance production at Lonza’s Geleen (NL) site. The new production line in Geleen will complement Lonza’s existing drug substance production network for the COVID-19 Vaccine and deliver a crucial JUBILANT HOLLISTERSTIER EXPANDS STERILE INJECTABLE MFG Jubilant HollisterStier is investing $92 million to expand sterile injectable manufacturing capacity at its site in Spokane, WA. The expansion includes the set up of a high-speed, 400 vials a minute, injectable fill line with isolator technology, which will add 50% capacity at the Spokane facility. PHARMABLOCK SCIENCES PARTNERS WITH SHOUYAO HOLDINGS PharmaBlock Sciences (Nanjing) Inc., an innovative chemistry products and services provider throughout the pharmaceutical R&D process and commercialization, and Shouyao Holdings Co., Ltd., a biopharmaceutical company focusing on innovative tumor and diabetes drug development, have entered a strategic partnership for the CMC development and manufacturing of Shouyao’s leading BIOVECTRA INC. UNVEILS NEW LOGO AND BRAND Biovectra Inc., a global contract development and manufacturing organization, has launched a new logo and brand to align with the growing company’s full suite of expertise and core values. “Over the last few years, we have grown significantly in size and added new capabilities, like our fully-operational large-scale biomanufacturing facility in Windsor, Nova Scotia,” said Biovectra chief DRIVING EFFICIENCIES IN TODAY’S COMPLEX TRIALS Murray Aitken is the executive director of the IQVIA Institute for Human Data Science. Mr. Aitken is a renowned expert on the challenges facing the global healthcare industry, and the prospects for improving patient outcomes through managing costs and THE FUTURE OF CONTINUOUS BIOPROCESSING Dr. Karoline Hahn is a Senior Consultant for Advanced Therapies on KCR’s Trial Execution Consulting team with 20 years of experience in the biopharmaceutical industry, devising regulatory strategies and leading interactions with global health authorities. A geneticist by training, Dr. Hahn has extensive expertise in Advanced Therapies and provides top-tier strategic regulatory services in ADARE PHARMA EXPANDS EXECUTIVE LEADERSHIP TEAM Adare Pharma Solutions has strengthened its executive leadership team with two key hires. Robert Muschert has joined Adare as Chief Commercial Officer, and Dr. Vipan Dhall has joined as Chief Scientific Officer. These key additions aim to further advance Adare’s position as a technology driven ONYX SCIENTIFIC RECEIVES COMMERCIAL API LICENSE FOR UK Onyx Scientific, a small molecule API contract development and manufacturing organization has received a commercial API license for its UK facility. The license, granted by the Medicines and Healthcare Products Regulatory Agency (MHRA), allows Onyx to support API projects from pre-clinical studies to low volume commercial manufacture. NEWSMAKERS: LYNN ALLEN, VICE PRESIDENT OF BUSINESS For the past 20 years, MedPharm has been helping clients navigate the complexities of topical and transdermal drug delivery. In fact, MedPharm was the first company to achieve European approval of topical generic products with in vitro bioequivalence testing only. MedPharm has established a strong worldwide reputation as product development experts in topical and transdermal delivery Continue to Contract Pharma__
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WORLD CLASS CAPSULES NOW MADE IN BRAZIL ABBOTT TO DEPLOY RAPID COVID-19 TEST IN NJ GRAM CONTINUES AGGRESSIVE EXPANSION IN PARENTERALS CORONAVIRUS SARS-COV-2: ARCHITECTURE OF A PANDEMIC THE EVOLUTION OF THE ADC MANUFACTURER*
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NEWS | INDUSTRY NEWS MODERNA GETS $483M BARDA DEAL FOR COVID-19 VACCINE Award will fund manufacturing process scale-up to enable large-scale production in 2020 for pandemic response Contract Pharma Staff 04.17.20 ------------------------- * BREAKING NEWS | COLLABORATIONS & ALLIANCES | INDUSTRY NEWS KANEKA TO SUPPLY API FOR FUJIFILM’S AVIGAN TABLET Production of Avigan being ramped up for COVID-19 patients Contract Pharma Staff 04.17.20 ------------------------- * BIO NEWS | BIOLOGICS, PROTEINS, VACCINES| BREAKING
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HALIX ENTERS COVID-19 TIE-UP WITH UNIVERSITY OF OXFORD Alliance for the scale-up of a GMP manufacturing process and production of a coronavirus vaccine Contract Pharma Staff 04.17.20 ------------------------- ------------------------- * BREAKING NEWS | CGMP MANUFACTURE| CLINICAL TRIAL
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& ALLIANCES | INDUSTRY NEWS AZURRX, DELPHARM ENTER MANUFACTURING AGREEMENT For the clinical drug product supply of MS1819 therapy for exocrine pancreatic insufficiency Contract Pharma Staff 04.17.20 ------------------------- * BREAKING NEWS | COLLABORATIONS & ALLIANCES | INDUSTRY NEWS EVOTEC, LEON-NANODRUGS ENTER NANOMEDICINE PACT Evotec makes strategic investment in leon by leading the company's Series B funding round Contract Pharma Staff 04.17.20 ------------------------- * BREAKING NEWS | INDUSTRY NEWS EAGLE PHARMA’S DRUG SHOWS ANTIVIRAL ACTIVITY AGAINST COVID-19 IND submitted to FDA for clinical study at Hackensack University Medical Center to evaluate Ryanodex for treatment of COVID-19 patients Contract Pharma Staff 04.17.20 ------------------------- ------------------------- * BREAKING NEWS | FILL/FINISH| INDUSTRY NEWS
ABL SUPPORTS FILL/FINISH OF COVID-19 VACCINE CANDIDATE Utilizes its aseptic fill/finish facility to support confidential clients' COVID-19 vaccine development Contract Pharma Staff 04.17.20 ------------------------- * BREAKING NEWS | CLINICAL TRIALS| INDUSTRY NEWS
OCTAPHARMA SUPPORTS NEW COVID-19 TRIAL Aims to assess if Intravenous Immunoglobulin (IVIG) can halt coronavirus progression to respiratory failure Contract Pharma Staff 04.16.20 ------------------------- * BIOASSAY DEVELOPMENT| BREAKING
NEWS | INDUSTRY NEWS EUROFINS GENOMICS LAUNCHES SARS-COV-2 PLASMID DNA CONTROLS Can be used to detect the presence of SARS-CoV-2 virus and are intended for both R&D and diagnostic applications. Contract Pharma Staff 04.16.20 ------------------------- ------------------------- * BIOLOGICS, PROTEINS, VACCINES| BREAKING
NEWS | INDUSTRY NEWS SOLIGENIX LICENSES BTG’S COVACCINE HT FOR SARS-COV-2 Novel adjuvant has been shown to enhance both cell-mediated and antibody-mediated immunity Contract Pharma Staff 04.16.20 -------------------------* CLINICAL TRIALS
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HOW TO DESIGN TRIALS TO BE MORE PATIENT-CENTERED Three lessons learned and how pharma can use validated measures and strategies to engage patients at every stage in the drug developmentlifecycle.
Jean Paty, Vice President, Patient Centered Sciences, IQVIA, Matthew Reaney, Senior Principal, Patient Centered Sciences, IQVIA 04.16.20 ------------------------- * BREAKING NEWS | DRUG DEVELOPMENT| TRIALS &
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REGENERON'S BLA FOR EBOLA COCKTAIL GETS PRIORITY REVIEW VelociSuite technologies facilitate rapid generation of optimized antibodies allowing for cell line production and large-scale bioreactor manufacturing Contract Pharma Staff 04.16.20 ------------------------- * BREAKING NEWS | INDUSTRY NEWS| INJECTABLES
KEYSTONE EXPANDS CAPACITY FOR VIAL & SYRINGE PACKAGING Spurred by increased demand from biologics and vaccines sectors Contract Pharma Staff 04.15.20 ------------------------- * BREAKING NEWS | INDUSTRY NEWS SEIKAGAKU ACQUIRES DALTON PHARMA SERVICES Global Healthcare Advisors initiates transaction, serves as advisor Contract Pharma Staff 04.15.20 ------------------------- * BIO NEWS | BREAKING NEWS| INDUSTRY NEWS
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WUXI BIOLOGICS PASSES EMA GMP INSPECTION Suzhou site clears regulatory hurdle with not critical findings Contract Pharma Staff 04.15.20 -------------------------Covid-19
* Moderna Gets $483M BARDA Deal for COVID-19 Vaccine * Kaneka to Supply API for Fujifilm’s Avigan Tablet * HALIX Enters COVID-19 Tie-up with University of Oxford * Eagle Pharma’s Drug Shows Antiviral Activity Against COVID-19 * ABL Supports Fill/Finish of COVID-19 Vaccine Candidate * TraceLink Launches Digital Supply Chain Solutions * Octapharma Supports New COVID-19 Trial * PPD’s AES Biz Launches Patient-Transfer Program * Eurofins Genomics Launches SARS-CoV-2 Plasmid DNA Controls * Soligenix Licenses BTG’s CoVaccine HT for SARS-CoV-2View Covid-19 >
Breaking News
* Moderna Gets $483M BARDA Deal for COVID-19 Vaccine * Kaneka to Supply API for Fujifilm’s Avigan Tablet * HALIX Enters COVID-19 Tie-up with University of Oxford * AzurRx, Delpharm Enter Manufacturing Agreement * Evotec, leon-nanodrugs Enter Nanomedicine Pact * Eagle Pharma’s Drug Shows Antiviral Activity Against COVID-19 * ABL Supports Fill/Finish of COVID-19 Vaccine Candidate * TraceLink Launches Digital Supply Chain Solutions * Octapharma Supports New COVID-19 Trial * PPD’s AES Biz Launches Patient-Transfer Program View Breaking News >CURRENT ISSUE
APRIL 2020
* Coronavirus Crisis: Industry Impact Survey * Coronavirus SARS-CoV-2: Architecture of a Pandemic * CEO Spotlight: Will Downie * The Evolution of the ADC Manufacturer * GRAM Continues Aggressive Expansion in Parenterals * De-risking the Solid Form Landscape of an APIView More >
Contract Service Directory Search the Directories for A Company: 3C Packaging3M Drug Delivery SystemsA Davies Laboratories LtdA&A CoatingsA+ Secure PackagingA.C. CompactingAaron Kendell Packaging (AEK)AB BioTechnologies, Inc.AB ControlsAbbVie Contract ManufacturingABICH SrlABL IncAbon Pharmaceuticals, LLCABOX Automation CorporationABS Pharma ProjectsAbsorption SystemsAbzenaAcanthus Research Inc.AccelerationAccelovanceAcclaim Pharma ResearchAccucapsAccugen Laboratories, Inc.Accupac, Inc.ACG GroupACG North AmericaACORN CROAcquire AutomationACR Image MetrixAct AssociatesActivation Laboratories Ltd. (Actlabs)AcuNova Life SciencesAdaptive Clinical SystemsAdare PharmaceuticalsAdentsAdept Technology, Inc.Adjutor Healthcare Pty LtdAdmix Pharma LaboratoriesADPEN Laboratories Inc.AdvaCare Pharma USAAdvanced Analytical Testing Laboratories, Inc.Advanced Biomedical Research, Inc.Advanced Biotechnologies IncAdvanced Chemistry Development, Inc. 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* Eurofins Offers Coronavirus Testing Services * Eagle Pharma’s Drug Shows Antiviral Activity Against COVID-19 * Moderna Gets $483M BARDA Deal For COVID-19 Vaccine * BioSig Acquires Anti-viral Agent To Treat COVID-19 * Soligenix Licenses BTG’s CoVaccine HT For SARS-CoV-2 TOP 25 PHARMA & BIOPHARMA TOP 25 PHARMA AND BIOPHARMA COMPANIES -------------------------* 01 Pfizer, Inc.
-------------------------* 02 Novartis
-------------------------* 03 Roche
------------------------- * 04 Johnson & Johnson -------------------------* 05 Sanofi
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