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GO WITH THE FLOW: SOLVING POWDER FLOW CHALLENGES BEFORE A poorly flowing powder can affect tablet quality at every step in the process. Key factors to consider when encountering a powder that doesn’t flow well are formulation design, storage conditions, tablet design, and mechanical design of processing equipment. MANNOGEM® MANNITOL 2080 FROM SPI PHARMA Mannogem Mannitol 2080 is often used in API protection and dissolution enhancement for swallow tablets. HOME | AMERICAN PHARMACEUTICAL REVIEWARTICLESNEWSBLOGEVENTSVIDEOSFEATURED PRODUCTS Entegris Inc., a world-class supplier of advanced materials and process solutions for the semiconductor and other high-technology industries, announced the expansion of its Life Sciences manufacturing facilities located in Billerica, MA; Bloomington, NOVARTIS ANNOUNCES Q1 FINANCIALS AND OUTLOOK Q1 net sales declined -2% (cc¹, +1% USD), due to prior year COVID-19 related forward purchasing (approximately USD 0.4 billion) Pharmaceuticals BU in line with prior year (0% cc, +4% USD) with continued strong growth from Entresto (+34% cc), Zolgensma (+81% cc), and Cosentyx (+11% cc).Kesimpta sales reached USD 50 million; Oncology BU grew +1% (cc, +4% USD) driven by Kymriah REDUCING THE RISKS OF PARTICLES ON THE OUTSIDE OF VIALSSEE MORE ON AMERICANPHARMACEUTICALREVIEW.COM ENVIRONMENTAL MONITORING AND TESTING EQUIPMENT Each detergent will contain a specific formula to meet the needs of the unique cleaning requirement, which can vary from a hard surface, to manufacturing equipment, to laboratory glassware. Types of detergents include anionic detergents, cationic detergents, amphoteric detergents, alkaline detergents, and more. Showing 11 of 11 products. ENVIRONMENTAL MONITORING PERFORMANCE QUALIFICATION (EMPQSEE MORE ON AMERICANPHARMACEUTICALREVIEW.COM WATCH VIDEO: GLASS BREAKAGE BENCH TIP In a recent poll US drug makers told American Pharmaceutical Review they would like to learn more about glass breakage in relation to primary packaging. In this video, we discuss what causes glass to break and what pharma companies can do about it. NITROSAMINES IN PHARMACEUTICALS: TOXICITY, RISK ANALYSISSEE MORE ON AMERICANPHARMACEUTICALREVIEW.COM NICOLET 6700 FT-IR SPECTROMETER FROM THERMO FISHER Description. Thermo Scientific Nicolet 6700 FT-IR spectrometer is a fully upgradeable, routine and advanced research FT-IR spectrometer focused on power and flexibility. The Nicolet 6700 FT-IR spectrometer has the power to handle both research and routine analysis experiments. Every facet of the Nicolet 6700 FT-IR spectrometer hasbeen
GO WITH THE FLOW: SOLVING POWDER FLOW CHALLENGES BEFORE A poorly flowing powder can affect tablet quality at every step in the process. Key factors to consider when encountering a powder that doesn’t flow well are formulation design, storage conditions, tablet design, and mechanical design of processing equipment. MANNOGEM® MANNITOL 2080 FROM SPI PHARMA Mannogem Mannitol 2080 is often used in API protection and dissolution enhancement for swallow tablets.COVID-19 UPDATES
Coronavirus disease (COVID-19) is an infectious disease caused by the coronavirus SARS-CoV-2. Here we have collected APR news related to the COVID-19 pandemic, vaccination efforts and emerging treatments. PFIZER AND BIONTECH TO PROVIDE 500 MILLION DOSES OF COVID Pfizer Inc. and BioNTech SE announced plans 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 the first half of 2022, to further support the multilateral efforts to address the surge of infection in many parts of the world and to help end the pandemic. The government will, inturn
DATA INTEGRITY: 2020 FDA DATA INTEGRITY OBSERVATIONS IN In 2020 thus far, numerous warning letters have been issued from the FDA citing data integrity violations. Common findings violate principles of ALCOA+, 21 CFR Part 11, and the FDA’s data integrityguidance document.
FDA AUTHORIZES LOWER INTRAVENOUS AND SUBCUTANEOUS DOSE OF Regeneron Pharmaceuticals Inc. announced the U.S. FDA updated the Emergency Use Authorization (EUA) for REGEN-COV™, lowering the dose to 1,200 mg (600 mg casirivimab and 600 mg imdevimab), which is half the dose originally authorized. As part of the updated EUA, REGEN-COV should be administered by intravenous (IV) infusion; subcutaneous (SC) injections are an alternative when IV ENTEGRIS EXPANDS LIFE SCIENCES PRODUCTION CAPACITY AND Entegris Inc., a world-class supplier of advanced materials and process solutions for the semiconductor and other high-technology industries, announced the expansion of its Life Sciences manufacturing facilities located in Billerica, MA; Bloomington, MN; and Logan, UT.. The expansions are part of Entegris’ capital expenditures plan to invest approximately $30 million in life sciences ORAL SOLID DOSAGE TRENDS American Pharmaceutical asked our readers several questions regarding the technologies and processes they use, and the issues they face, when developing oral solid dosage (OSD) products. The results of our survey are below and provide an insight into the challenges manufacturers face when bringing new OSD products to market. NOVARTIS ANNOUNCES IPTACOPAN MET PRIMARY ENDPOINT IN RARE Novartis announced Phase II primary endpoint data showing investigational iptacopan (LNP023) – a first-in-class, oral, targeted factor B inhibitor – reduced protein in the urine (proteinuria), an increasingly recognized surrogate marker correlating with progression to kidney failure, and showed promise in stabilizing kidney function in patients with IgA nephropathy (IgAN). ALCONOX INC. ANNOUNCES 75TH ANNIVERSARY AS AN For over 75 years, Alconox has been a leader in detergents, used extensively in the laboratory, pharmaceutical, biotech, medical device, healthcare, electronics, solar, food, nuclear, optics, cannabis and cosmetics industries.. Regarding the anniversary, Elliot M. Lebowitz, Chief Operating Officer remarked, “As a member of this third-generation, family-owned business, I am so proud to be CONSIDERATIONS FOR FORMULATION STRATEGIES The comprehensive nature of drug development, combined with the demands of multiple stakeholders, requires drug developers to manage both resources and risk if they are to efficiently bring new products to market. The sequential, interdependent nature of the drug development process means that each decision can have a major impact on future development. SPINOGENIX GRANTED FDA ORPHAN DRUG DESIGNATION FOR SPG302 Spinogenix, Inc. a pharmaceutical company focused on the development of novel synaptogenic small molecule therapies for CNS disorders and rare diseases, announced it has been granted Orphan Drug Designation (ODD) for SPG302 in amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) by the U.S. FDA. By obtaining orphan drug designation, SPG302 is now eligible for such HOME | AMERICAN PHARMACEUTICAL REVIEWARTICLESNEWSBLOGEVENTSVIDEOSFEATURED PRODUCTS Eurofins Technologies announces the launch of its GSD NovaType III SARS-CoV-2 RT-PCR assay, developed for the rapid detection of SARS-CoV-2 Variants of Concern including B.1.617 (“India”), B.1.427/B.1.429 (“California/USA”), B.1.351 (“South Africa”) ENVIRONMENTAL MONITORING PERFORMANCE QUALIFICATION (EMPQSEE MORE ON AMERICANPHARMACEUTICALREVIEW.COM UNDERSTANDING FDA’S CSA GUIDANCE IN THE CONTEXT OF CURRENT Senthil Gurumoorthi has over 17 years of diverse experience in biopharmaceutical business technologies with leadership expertise in Technology delivery, Risk, Inspection, Audit and Quality Management. Senthil leads the IT Quality function at Gilead Sciences, is a member of the FDA-Industry CSA Team and is a contributing author of the GAMP GPG Data Integrity by Design. BURKHOLDERIA CEPACIA COMPLEX CASE STUDIES Recently, regulatory scrutiny has increased due to BCC. BCC includes Burkholderia cepacia and several other species of organisms. The exact number of species changes depending upon the reference, but at least 20 organisms are included. NITROSAMINES IN PHARMACEUTICALS: TOXICITY, RISK ANALYSISSEE MORE ON AMERICANPHARMACEUTICALREVIEW.COM REGULATORY CONSIDERATIONS FOR THE DEVELOPMENT OF NOVELSEE MORE ON AMERICANPHARMACEUTICALREVIEW.COM JUSTIFICATION OF INCUBATION CONDITIONS USED FORSEE MORE ON AMERICANPHARMACEUTICALREVIEW.COM NICOLET 6700 FT-IR SPECTROMETER FROM THERMO FISHER Description. Thermo Scientific Nicolet 6700 FT-IR spectrometer is a fully upgradeable, routine and advanced research FT-IR spectrometer focused on power and flexibility. The Nicolet 6700 FT-IR spectrometer has the power to handle both research and routine analysis experiments. Every facet of the Nicolet 6700 FT-IR spectrometer hasbeen
UNDERSTANDING THE HARVEST OPERATION USING DYNAMIC PARTICLE The harvest process most often used during the primary recovery of cell-based biopharmaceuticals is continuous centrifugation followed by depth filtration. While it is widely used in the industry, little attention is typically paid to this unit operation because of the lack of analytical tools to develop and monitor the performance of thisstep.
DISINFECTION QUALIFICATION TESTING--CONSIDERATIONS FOR THE disinfection qualification testing— considerations for the aseptic and cleanroom manufacturing environment by dave rottjakob, m.t. (ascp)december, 2013
HOME | AMERICAN PHARMACEUTICAL REVIEWARTICLESNEWSBLOGEVENTSVIDEOSFEATURED PRODUCTS Eurofins Technologies announces the launch of its GSD NovaType III SARS-CoV-2 RT-PCR assay, developed for the rapid detection of SARS-CoV-2 Variants of Concern including B.1.617 (“India”), B.1.427/B.1.429 (“California/USA”), B.1.351 (“South Africa”) ENVIRONMENTAL MONITORING PERFORMANCE QUALIFICATION (EMPQSEE MORE ON AMERICANPHARMACEUTICALREVIEW.COM UNDERSTANDING FDA’S CSA GUIDANCE IN THE CONTEXT OF CURRENT Senthil Gurumoorthi has over 17 years of diverse experience in biopharmaceutical business technologies with leadership expertise in Technology delivery, Risk, Inspection, Audit and Quality Management. Senthil leads the IT Quality function at Gilead Sciences, is a member of the FDA-Industry CSA Team and is a contributing author of the GAMP GPG Data Integrity by Design. BURKHOLDERIA CEPACIA COMPLEX CASE STUDIES Recently, regulatory scrutiny has increased due to BCC. BCC includes Burkholderia cepacia and several other species of organisms. The exact number of species changes depending upon the reference, but at least 20 organisms are included. NITROSAMINES IN PHARMACEUTICALS: TOXICITY, RISK ANALYSISSEE MORE ON AMERICANPHARMACEUTICALREVIEW.COM REGULATORY CONSIDERATIONS FOR THE DEVELOPMENT OF NOVELSEE MORE ON AMERICANPHARMACEUTICALREVIEW.COM JUSTIFICATION OF INCUBATION CONDITIONS USED FORSEE MORE ON AMERICANPHARMACEUTICALREVIEW.COM NICOLET 6700 FT-IR SPECTROMETER FROM THERMO FISHER Description. Thermo Scientific Nicolet 6700 FT-IR spectrometer is a fully upgradeable, routine and advanced research FT-IR spectrometer focused on power and flexibility. The Nicolet 6700 FT-IR spectrometer has the power to handle both research and routine analysis experiments. Every facet of the Nicolet 6700 FT-IR spectrometer hasbeen
UNDERSTANDING THE HARVEST OPERATION USING DYNAMIC PARTICLE The harvest process most often used during the primary recovery of cell-based biopharmaceuticals is continuous centrifugation followed by depth filtration. While it is widely used in the industry, little attention is typically paid to this unit operation because of the lack of analytical tools to develop and monitor the performance of thisstep.
DISINFECTION QUALIFICATION TESTING--CONSIDERATIONS FOR THE disinfection qualification testing— considerations for the aseptic and cleanroom manufacturing environment by dave rottjakob, m.t. (ascp)december, 2013
HOME | AMERICAN PHARMACEUTICAL REVIEW Eurofins Technologies announces the launch of its GSD NovaType III SARS-CoV-2 RT-PCR assay, developed for the rapid detection of SARS-CoV-2 Variants of Concern including B.1.617 (“India”), B.1.427/B.1.429 (“California/USA”), B.1.351 (“South Africa”)COVID-19 UPDATES
Coronavirus disease (COVID-19) is an infectious disease caused by the coronavirus SARS-CoV-2. Here we have collected APR news related to the COVID-19 pandemic, vaccination efforts and emerging treatments. PFIZER AND BIONTECH TO PROVIDE 500 MILLION DOSES OF COVID Pfizer Inc. and BioNTech SE announced plans 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 the first half of 2022, to further support the multilateral efforts to address the surge of infection in many parts of the world and to help end the pandemic. The government will, inturn
PHARMACEUTICAL FACILITY SANITIZATION: BEST PRACTICES Cleanrooms and clean areas must be regularly cleaned and disinfected. This is normally undertaken using a detergent step, followed by the application of a disinfectant. It may be necessary to remove the residue of the disinfectant using water. Cleaning and disinfection should also extend to equipment. Furthermore, with personnel, sanitization is important in relation to glove hands. FDA AUTHORIZES LOWER INTRAVENOUS AND SUBCUTANEOUS DOSE OF Regeneron Pharmaceuticals Inc. announced the U.S. FDA updated the Emergency Use Authorization (EUA) for REGEN-COV™, lowering the dose to 1,200 mg (600 mg casirivimab and 600 mg imdevimab), which is half the dose originally authorized. As part of the updated EUA, REGEN-COV should be administered by intravenous (IV) infusion; subcutaneous (SC) injections are an alternative when IV NOVARTIS ANNOUNCES IPTACOPAN MET PRIMARY ENDPOINT IN RARE Novartis announced Phase II primary endpoint data showing investigational iptacopan (LNP023) – a first-in-class, oral, targeted factor B inhibitor – reduced protein in the urine (proteinuria), an increasingly recognized surrogate marker correlating with progression to kidney failure, and showed promise in stabilizing kidney function in patients with IgA nephropathy (IgAN). ALCONOX INC. ANNOUNCES 75TH ANNIVERSARY AS AN For over 75 years, Alconox has been a leader in detergents, used extensively in the laboratory, pharmaceutical, biotech, medical device, healthcare, electronics, solar, food, nuclear, optics, cannabis and cosmetics industries.. Regarding the anniversary, Elliot M. Lebowitz, Chief Operating Officer remarked, “As a member of this third-generation, family-owned business, I am so proud to be ENTEGRIS EXPANDS LIFE SCIENCES PRODUCTION CAPACITY AND Entegris Inc., a world-class supplier of advanced materials and process solutions for the semiconductor and other high-technology industries, announced the expansion of its Life Sciences manufacturing facilities located in Billerica, MA; Bloomington, MN; and Logan, UT.. The expansions are part of Entegris’ capital expenditures plan to invest approximately $30 million in life sciences PHARMACEUTICAL MATERIAL TESTING EQUIPMENT (MATERIAL Pharmaceutical material testing instruments analyze the properties of the final, physical state of manufactured pharmaceutical products. Material qualities that may be tested for include adhesive and cohesive properties, fracturability, stability, and projected shelflife.
SPINOGENIX GRANTED FDA ORPHAN DRUG DESIGNATION FOR SPG302 Spinogenix, Inc. a pharmaceutical company focused on the development of novel synaptogenic small molecule therapies for CNS disorders and rare diseases, announced it has been granted Orphan Drug Designation (ODD) for SPG302 in amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) by the U.S. FDA. By obtaining orphan drug designation, SPG302 is now eligible for such Please enable cookies.ONE MORE STEP
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