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PHARMTECH
Pharmaceutical Technology is the independent source for information, insight, and analysis on bio/pharmaceutical formulation, development,and manufacturing.
INDUSTRY NEWS
Harmonized Lifecycle Management Policy Aims to Drive Drug Quality and Innovation. May 26, 2021. FDA recently published a final guidance for making post-approval manufacturing changes to drugs and biologics, the culmination of a long-running effort to facilitate improvements in medical product quality through the product life cycle. EQUIPMENT - PHARMTECH Bag Dump Module for Bulk Solid Equipment. May 02, 2021. Munson Machinery introduced a new Bag Dump Module for installation on the lids of bulk solid mixers, blenders, size-reduction equipment, and storage vessels to maintain the dust produced when bulk materials are PHARMACEUTICAL TECHNOLOGY-03-15-2021 A Real-World Approach to Evaluating Cleanroom Garments. March 15, 2021. Operations. 2021 eBook. 1. Traditional methods of testing cleanroom garments fail to test for dynamic conditions in the cleanroom. A holistic approach considers particulate shedding and heat load during processing, as well as the impact of laundering on garmentlife cycle.
PHARMACEUTICAL TECHNOLOGY 2021 MJH Life Sciences ™ and . Pharmaceutical Technology. Allrights reserved.
FORMULATION
Using Quality by Design to Develop Fixed-Dose Combination Tablets. June 02, 2021. In the present investigation, the fixed-dose combination (FDC) tablet of Atorvastatin calcium and Ezetimibe was prepared by a quality-by-design approach using 23 factorial design.PHARMA INSIGHTS
Pharma Insights - Thought Leadership from Marketers | Sponsored Content. Lipoid GmbH. STERIS. Vetter Pharma.OUTSOURCING
Developing a Method for Success through Partnerships. Outsourcing method development offers multiple benefits to companies, including access to experience and expertise, streamlined costs, and developmenttime efficiencies.
BIOLOGICS APIS
Biologics Facilities Expand and Establish New Locations in 2021. May 14, 2021. The latest news about biologics facilities includes various expansions, new locations, and acquisitions in the bio/pharmaceuticalspace.
SMITHERS AVANZA
Smithers Avanza is a contract research organization (CRO) supporting the pharmaceutical, agrochemical, and chemical industries. Our scientists have expertise in large molecule bioanalysis, assay development, validation and sample analysis at our GLP- and GCP-compliant and CLIA registered laboratory.PHARMTECH
Pharmaceutical Technology is the independent source for information, insight, and analysis on bio/pharmaceutical formulation, development,and manufacturing.
INDUSTRY NEWS
Harmonized Lifecycle Management Policy Aims to Drive Drug Quality and Innovation. May 26, 2021. FDA recently published a final guidance for making post-approval manufacturing changes to drugs and biologics, the culmination of a long-running effort to facilitate improvements in medical product quality through the product life cycle. EQUIPMENT - PHARMTECH Bag Dump Module for Bulk Solid Equipment. May 02, 2021. Munson Machinery introduced a new Bag Dump Module for installation on the lids of bulk solid mixers, blenders, size-reduction equipment, and storage vessels to maintain the dust produced when bulk materials are PHARMACEUTICAL TECHNOLOGY-03-15-2021 A Real-World Approach to Evaluating Cleanroom Garments. March 15, 2021. Operations. 2021 eBook. 1. Traditional methods of testing cleanroom garments fail to test for dynamic conditions in the cleanroom. A holistic approach considers particulate shedding and heat load during processing, as well as the impact of laundering on garmentlife cycle.
PHARMACEUTICAL TECHNOLOGY 2021 MJH Life Sciences ™ and . Pharmaceutical Technology. Allrights reserved.
FORMULATION
Using Quality by Design to Develop Fixed-Dose Combination Tablets. June 02, 2021. In the present investigation, the fixed-dose combination (FDC) tablet of Atorvastatin calcium and Ezetimibe was prepared by a quality-by-design approach using 23 factorial design.PHARMA INSIGHTS
Pharma Insights - Thought Leadership from Marketers | Sponsored Content. Lipoid GmbH. STERIS. Vetter Pharma.OUTSOURCING
Developing a Method for Success through Partnerships. Outsourcing method development offers multiple benefits to companies, including access to experience and expertise, streamlined costs, and developmenttime efficiencies.
BIOLOGICS APIS
Biologics Facilities Expand and Establish New Locations in 2021. May 14, 2021. The latest news about biologics facilities includes various expansions, new locations, and acquisitions in the bio/pharmaceuticalspace.
SMITHERS AVANZA
Smithers Avanza is a contract research organization (CRO) supporting the pharmaceutical, agrochemical, and chemical industries. Our scientists have expertise in large molecule bioanalysis, assay development, validation and sample analysis at our GLP- and GCP-compliant and CLIA registered laboratory. EMA APPROVES NEW MANUFACTURING SITE FOR MODERNA COVID-19 6 hours ago · The European Medicines Agency (EMA) announced on June 11, 2021 that its committee for human medicines (CHMP) has approved Recipharm’s Monts, France facility for the production of Moderna COVID-19 vaccine finished product. Several other sites were given a positive opinion by CHMP for batch control/testing. The new site follows two other sites approved by CHMP in June for the EQUIPMENT - PHARMTECH Bag Dump Module for Bulk Solid Equipment. May 02, 2021. Munson Machinery introduced a new Bag Dump Module for installation on the lids of bulk solid mixers, blenders, size-reduction equipment, and storage vessels to maintain the dust produced when bulk materials arePHARMTECH | PAGE 2
Lonza and Moderna to Expand Their COVID-19 Vaccine Drug Substance Manufacturing Collaboration. June 02, 2021. By Pharmaceutical Technology Editors. The companies are expanding their collaboration to extend the drug substance manufacturing of Moderna’s COVID-19 vaccine with the addition of a new manufacturing line at Lonza’sGeleen
EU REGULATORS RECOMMEND NOT RELEASING BATCHES OF JANSSEN 6 hours ago · As a safety measure, supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 vaccine with API manufactured at Emergent BioSolutions’ Maryland facility. The European Medicines Agency (EMA)MANUFACTURING
Annex 1 and Isolator Operation. Decontamination, automation, and containment are important considerations. Monitoring Downstream Processing in Real Time. Near-infrared spectroscopy demonstrates process analytical technology capabilities. Detecting Pharma Processing Fingerprints. Raman spectroscopy delivers real time, non-destructive processTOPIC - PHARMTECH
2021 MJH Life Sciences and Pharmaceutical Technology. All rightsreserved.
FILL-FINISH
Fill-Finish. CONTINUE TO SITE. OR WAIT null SECS. Search. Spotlight. COVID-19 Update Analytics Dosage Forms Drug Development Manufacturing Outsourcing Quality Systems. Topic. View More Analytical Method Development APIs Aseptic Processing Biologic Drugs Drug Delivery Equipment Excipients Formulation Packaging Process Control/PAT ProcessOUTSOURCING
Developing a Method for Success through Partnerships. Outsourcing method development offers multiple benefits to companies, including access to experience and expertise, streamlined costs, and developmenttime efficiencies.
BRINTER SUCCESSFULLY CLOSES SEED FUNDING ROUND LED BY 15 hours ago · Brinter has successfully closed a €1.2 million (US $1.5 million) seed funding round, which was led by the early-stage venture capitalist Innovestor. Bioprinting start-up company, Brinter, has successfully closed a €1.2 million (US $1.5 million) seed funding round, which was led by the early COMPANIES | PHARMA MARKETPLACE | PHARMACEUTICAL TECHNOLOGY BioPharma Solutions, a business unit of Baxter, collaborates with pharmaceutical companies to provide contract manufacturing Jost Chemical Co. For 30 years Jost Chemical Co. has manufactured high purity chemical salts for the pharmaceutical, biopharmaceutical, nutrition and AbbVie. AbbVie Contract Manufacturing has nearly 30years of
PHARMTECHWEBCASTSMARKETPLACESPOTLIGHTTOPICNEWSPUBLICATIONS Biogen and Capsigen to Develop Novel AAV Capsids for up to $1.37 Billion. May 12, 2021. Biogen and Capsigen have entered into a strategic research collaboration to engineer novel AAV capsids to deliver gene therapies that address the underlying genetic causes of various central nervous system and neuromuscular disorders. EQUIPMENT - PHARMTECH Bag Dump Module for Bulk Solid Equipment. May 02, 2021. Munson Machinery introduced a new Bag Dump Module for installation on the lids of bulk solid mixers, blenders, size-reduction equipment, and storage vessels to maintain the dust produced when bulk materials are PHARMACEUTICAL TECHNOLOGY-03-15-2021 A Real-World Approach to Evaluating Cleanroom Garments. March 15, 2021. Operations. 2021 eBook. 1. Traditional methods of testing cleanroom garments fail to test for dynamic conditions in the cleanroom. A holistic approach considers particulate shedding and heat load during processing, as well as the impact of laundering on garmentlife cycle.
FORMULATION
Using Quality by Design to Develop Fixed-Dose Combination Tablets. June 02, 2021. In the present investigation, the fixed-dose combination (FDC) tablet of Atorvastatin calcium and Ezetimibe was prepared by a quality-by-design approach using 23 factorial design.PHARMA INSIGHTS
Pharma Insights - Thought Leadership from Marketers | Sponsored Content. Lipoid GmbH. STERIS. Vetter Pharma.PHARMA MARKETPLACE
Patheon. Patheon, a part of Thermo Fisher Scientific, provides end - to - end pharmaceutical services to support the entire biotechnology and pharmaceutical lifecycle. Thermo Fisher’s pharma services solutions helps customers accelerate innovation and drive productivity in the drug BioPharma Solutions, a business unit of Baxter PHARMTECH SPONSORED EBOOKS-05-04-2021 Medical Devices: Minimizing the Risk of Non-Compliance Through Enhanced Chemical Testing. May 04, 2021. PharmTech Sponsored eBooks. Click the title below to open this issue.PHARMTECH TALK
The White House sent Congress a summary of “topline” funding requests that continue efforts to combat the coronavirus pandemic and to restore the nation’s economic health.PROCESS VALIDATION
The CuDAL-Excel program, based on Microsoft (MS) Excel, has been developed to calculate the United States Pharmacopeia (USP) passing probability of content uniformity and dissolution tests for both sampling plan 1 and sampling plan 2 scenarios and for both immediate release and extended release requirements.SMITHERS AVANZA
Smithers Avanza is a contract research organization (CRO) supporting the pharmaceutical, agrochemical, and chemical industries. Our scientists have expertise in large molecule bioanalysis, assay development, validation and sample analysis at our GLP- and GCP-compliant and CLIA registered laboratory. PHARMTECHWEBCASTSMARKETPLACESPOTLIGHTTOPICNEWSPUBLICATIONS Biogen and Capsigen to Develop Novel AAV Capsids for up to $1.37 Billion. May 12, 2021. Biogen and Capsigen have entered into a strategic research collaboration to engineer novel AAV capsids to deliver gene therapies that address the underlying genetic causes of various central nervous system and neuromuscular disorders. EQUIPMENT - PHARMTECH Bag Dump Module for Bulk Solid Equipment. May 02, 2021. Munson Machinery introduced a new Bag Dump Module for installation on the lids of bulk solid mixers, blenders, size-reduction equipment, and storage vessels to maintain the dust produced when bulk materials are PHARMACEUTICAL TECHNOLOGY-03-15-2021 A Real-World Approach to Evaluating Cleanroom Garments. March 15, 2021. Operations. 2021 eBook. 1. Traditional methods of testing cleanroom garments fail to test for dynamic conditions in the cleanroom. A holistic approach considers particulate shedding and heat load during processing, as well as the impact of laundering on garmentlife cycle.
FORMULATION
Using Quality by Design to Develop Fixed-Dose Combination Tablets. June 02, 2021. In the present investigation, the fixed-dose combination (FDC) tablet of Atorvastatin calcium and Ezetimibe was prepared by a quality-by-design approach using 23 factorial design.PHARMA INSIGHTS
Pharma Insights - Thought Leadership from Marketers | Sponsored Content. Lipoid GmbH. STERIS. Vetter Pharma.PHARMA MARKETPLACE
Patheon. Patheon, a part of Thermo Fisher Scientific, provides end - to - end pharmaceutical services to support the entire biotechnology and pharmaceutical lifecycle. Thermo Fisher’s pharma services solutions helps customers accelerate innovation and drive productivity in the drug BioPharma Solutions, a business unit of Baxter PHARMTECH SPONSORED EBOOKS-05-04-2021 Medical Devices: Minimizing the Risk of Non-Compliance Through Enhanced Chemical Testing. May 04, 2021. PharmTech Sponsored eBooks. Click the title below to open this issue.PHARMTECH TALK
The White House sent Congress a summary of “topline” funding requests that continue efforts to combat the coronavirus pandemic and to restore the nation’s economic health.PROCESS VALIDATION
The CuDAL-Excel program, based on Microsoft (MS) Excel, has been developed to calculate the United States Pharmacopeia (USP) passing probability of content uniformity and dissolution tests for both sampling plan 1 and sampling plan 2 scenarios and for both immediate release and extended release requirements.SMITHERS AVANZA
Smithers Avanza is a contract research organization (CRO) supporting the pharmaceutical, agrochemical, and chemical industries. Our scientists have expertise in large molecule bioanalysis, assay development, validation and sample analysis at our GLP- and GCP-compliant and CLIA registered laboratory. EQUIPMENT - PHARMTECH Bag Dump Module for Bulk Solid Equipment. May 02, 2021. Munson Machinery introduced a new Bag Dump Module for installation on the lids of bulk solid mixers, blenders, size-reduction equipment, and storage vessels to maintain the dust produced when bulk materials areINDUSTRY NEWS
Harmonized Lifecycle Management Policy Aims to Drive Drug Quality and Innovation. May 26, 2021. FDA recently published a final guidance for making post-approval manufacturing changes to drugs and biologics, the culmination of a long-running effort to facilitate improvements in medical product quality through the product life cycle. NEW BIOTHERAPIES PUSH TECHNOLOGICAL INNOVATION FORWARD The emergence of new biotherapeutics is both the driver and result of innovative drug development technologies. The emergence of new biotherapeutics has prompted the advancement of innovative technologies that enable or support unique approaches to biotherapeutic drug development, including vaccines FDA PUBLISHES GUIDANCE DOCUMENTS TO ENHANCE SUPPLY CHAIN FDA published guidance documents on June 3, 2021, that provide recommendations for complying with the Drug Supply Chain Security Act (DSCSA) in order to identify and trace drug products as they move through the supply chain. Two final guidance documents and two draft guidance documents were issued. Product Identifiers Under the Drug Supply Chain Security Act, Questions and AGC BIOLOGICS TO SUPPLY MORE PLASMID DNA FOR PFIZER On June 7, 2021, AGC Biologics, a contract development and manufacturing organization (CDMO), announced that it has partnered with BioNTech to further supply plasmid DNA (pDNA) starting material for the Pfizer-BioNTech COVID-19 vaccine at AGC’s Heidelberg, Germany, facility. pDNA starting material is an essential component of BioNTech’s mRNA-based vaccine manufacturing process. EMERSON INTEGRATES MTP PROCESS AUTOMATION STANDARD INTO The Module Type Package standard is now supported in Emerson’s DCS and PLCs. Emerson announced in a June 3, 2021 press release that it has integrated the emerging Module Type Package (MTP) process automation standard into its control systems for both distributed control systems (DCS) and CATALENT'S BIOAVAILABILITY AND DEVELOPMENT TOOLKIT OptiForm® Solution Suite is a fast, flexible, and fact-based screening platform, which works in combination with Catalent’s comprehensive bioavailability enhancing technology toolkit. From its network of development and manufacturing facilities, Catalent provides customers with end-to-end API SYNTHESIS AND MANUFACTURING, SMALL MOLECULE Lonza to Add New Small-Molecule Manufacturing Complex to Switzerland Site. April 26, 2021. By Pharmaceutical Technology Editors. Lonza’s new complex will occupy 2000 m2 of the facility with six levels of manufacturing space and will provide FDA APPROVES TREATMENT FOR PLASMINOGEN DEFICIENCY TYPE 1 FDA announced on June 4, 2021, that it has approved Ryplazim (plasminogen, human-tmvh) to treat plasminogen deficiency type 1. Also known as hypoplasminogenemia, the rare disorder can impair tissue and organ function and may lead to blindness, according to the agency. Ryplazim was granted Orphan ASSESSING RISK AND PRODUCTION OF POTENT SUBSTANCES Highly potent drug substances—and drug products—are generally considered to have occupational exposure limits (OELs) ofDetails
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