Search results for "FDA"
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Advancing QbD in the EU
However, EMA has not been a strong driving force behind the adoption of QbD in the EU compared with FDA in the United States.
Recently, both EMA and the EC have experienced pressure from the…
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Address the complexity of protein characterization
Since the FDA approved the first monoclonal based therapy in 1985, mAbs have had significant clinical success and have been used to provide effective treatment for a range of diseases. Durin…
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Getting your investigational drug regulatory ready
Navigating regulatory requirements can be an overwhelming and time-consuming part of the translational journey. From the submission of an investigational new drug (IND) application, regulators…
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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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