Search results for " FDA"
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Design and Qualification of Single-Use Systems
International Council for Harmonization (ICH) Q7, European Medicines Agency (EMA) Q7, and FDA
Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients incorporate essentially…
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Ligand-Binding Assays and the Determination of Biosimilarity
…veloping a biosimilar and something that is expected by both the European Medicines Agency (EMA) and FDA, according to Gino Grampp, R&D policy director for Amgen. Physicochemical assays for testing o…
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Biopharma Manufacturers Respond to Ebola Crisis
GlaxoSmithKline’s (GSK) Okairos unit (Basel, Switzerland) recently obtained FDA approval for Phase I testing of a vaccine developed in collaboration with NIAID’s Vaccine Research Center and has launch…
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Continued Process Verification for Biopharma Manufacturing
Guidance issued by FDA in 2011 (1) emphasized the importance of manufacturers undertaking CPV as an integral part of the process validation lifecycle. CPV will provide the manufacturer with assurance …
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Gowning Practices Provide Clues to cGMP Compliance
This concept is broadly embraced across the globe and promulgated by drug regulatory agencies, such as FDA in the United States, the European Medicines Agency in the European Union, and the World Heal…
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State of Quality and Compliance in the Biopharmaceutical Industry
The late 1990s and early 2000s witnessed a slew of enforcement actions by FDA that included multiple Form 483 observations, warning letters, and consent decrees resulting from facility inspections. Th…
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Operational Excellence: More Than Just Process Improvement
To tackle human-error-caused deviations, the deviation management process was redesigned to bring it into line with current FDA expectations and industry best practices, and to assure that the people …
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Report from the 12th Plasma Product Biotechnology Forum
Despite the unusual raw material, there is a well-established and understood regulatory pathway through FDA-CBER. SAb Therapeutics has several projects in the pipeline, spanning from Phase 1 to Phase …
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Genetic Vaccine Platforms Demonstrate Their Potential
This situation has started to change with FDA granting Emergency Use Authorizations to the mRNA vaccines from Pfizer-BioNTech and Moderna for COVID-19 in late 2020 and approval for the viral-vector va…
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New Therapies Present Scaling Challenges
Spark received FDA approval for its gene therapy product, Luxturna (voretigene neparvovec-rzyl), for treating an inherited retinal disease, in December 2017 (5).
“For example, mAbs rely heavil…