Search results for "FDA" in Articles / App Notes
Article
Elucidating Biosimilars Characterization
Quintiles: The amino-acid sequence of a biosimilar molecule is one of the starting points in determining similarity to the originator medicine, with the draft guidance from FDA implying that a biosimi…
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Milestones and Moderate Progress in 2012 Drug Approvals
First gene therapy and plant-based expression vector products approved in 2012.
In terms of product approvals, the past year can be considered reasonably successful. Twelve biopharm…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
BIOSIMILARS
The FDA and European Medicines Agency (EMA) have indicated that the clinical testing requirements for a biosimilar drug can be reduced if it can be demonstrated that the biosimilar can…
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Quality by design for biotechnology products—part 1
US FDA. Guidance for Industry: Q10 Quality systems approach to pharmaceutical CGMP regulations. Bethesda, MD; 2006.
4. US FDA. Guidance for industry: PAT—A framework for innovative pharmaceutical …
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Maximum Output Starts with Optimized Upstream Processing
For instance, Regeneron has been working with FDA and the US government to rapidly scale up production of its REGEN-COV antibody cocktail. The company is leveraging production and manufacturing platfo…
Article
Reimagining Affordable Biosimilars
EMA regulations do not require animal immunogenicity studies, while FDA and several other regulatory agencies require preclinical results prior to initiating clinical trials (28).
Table II.…
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Tools and Processes for Mature and Emerging Therapies
Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) told the audience at an FDA Town Hall session that the agency is gearing up f…
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
…at it currently has more than 220 individual members and more than 70 company members, ranging from FDA and the National Institute of Science and Technology, to biopharma companies, software vendors,…
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An Analytical Approach to Biosimilar Drug Development
FDA has indicated that interchangeability likely will be handled in the post-approval setting. However, this is a topic under significant and lengthy discussion within the agency. The EMA does not add…
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Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
Interest in Cutting-Edge Therapies Continues to Grow
With FDA’s first approvals of cell and gene therapies now more than a year old, activity in these areas shows no signs of slowing down. Proce…