Search results for " FDA" in Articles / App Notes
Article
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…
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Guidance documents from regulatory health authorities, such as FDA and the European Medicines Agency (EMA), emphasize the importance of extensive analytical characterization in showing the similarity …
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Ensuring Viral Safety of Viral Vaccines and Vectors
In 2014, using next-generation sequencing (NGS), FDA’s Center for Biologics Evaluation and Research (CBER) retrovirus laboratory identified a novel rhabdovirus in Spodoptera frugiperda type 9 (Sf9) ce…
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Understanding Validation and Technical Transfer, Part 3
A consultation document [2]published by the European Commission (3) and an FDA guidance document on human somatic cell therapy and gene therapy (4) provide useful information for developing validation…