Search results for "FDA" in Articles / App Notes
Article
Digitalization: The Route to Biopharma 4.0
One of the critical FDA guidance documents that applies to digitalization efforts is that of Part 11 of Title 21 of the Code of Federal Regulations (Electronic Records; Electronic Signatures). This do…
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How to Use Multiwell Plates With Manual Operation
FDA initiatives such as quality by design (QbD) put demands on better process understanding. High-throughput tools like PreDictor™ plates prefilled with chromatography resins make it possible to explo…
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Top Process Development Trends for 2022 and a Look into 2023
FDA approved 37 drugs in 2022, within the normal range for the past decade or so. The European Medicines Agency (EMA) was even more successful—approving a record 55 therapies. More than half of thes…
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Chromatography for the Diversified Antibody Pipeline
Furthermore, we have experienced that FDA has published their guidance for development of this new class of antibodies. I believe everyone is expecting that they will increase in the future.
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Join the Plasma Product Biotechnology Meeting
The conference will host participants from all major plasma fractionator companies and additionally this year we have the privilege to welcome Dr Dorothy Scott from FDA and Branch Chief of the Plasma …
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Developing a Robust Bioprocess Using Mechanistic Models
Regulatory agencies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA) demand strict requirements on process characterization and validation studies and ask for a deep …
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Analysis of mRNA Therapeutics and Vaccines
Analytical approaches must keep pace to ensure the identity, safety, and efficacy of evolving mRNA candidates.
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Top Process Development Trends for 2021 and a Look into 2022
Another aspect of this is the manufacturing process and its robustness as it pertains to compliance with process validation requirements set forth by the FDA and ICH (International Council for Harmoni…
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Track-and-Trace Progress Benefits Supply-Chain Security Efforts
COVID-19 vaccines, approved under emergency use authorization, were not required to meet serialization requirements, but they have been properly labelled to meet FDA requirements, he says, complete wi…
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High-Quality Chromatography System Meets Predesigned DeltaV for Integrated Manufacturing
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Nearly 50% of the warning letters issued by the FDA cite 21 CFR data integrity violations. Implementing a distributed control system for facility-wide control of …