Search results for "biologic"
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Evaluating Design Margin, Edge of Failure and Process
ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, 2.3.1 Process-Related Considerations states (4):
“Adequate design of a process and knowled…
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FDA Urged to Preserve Biosimilar Naming Conventions
“These groups understand that the INN approach to biosimilar naming has proven safe and effective in Europe; it has worked in the United States for chemical drugs and currently approved biologics, the…
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Concentrating Feed—an Applicable Approach to Improve Antibody Production
In this study, the authors evaluated different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture. By raising the pH or by adding surfactants, the fe…
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Q&As with Industry Leaders
…Blackwell, President, Windshire Group, LLC
Regulatory Requirements for Safe and Efficient Biologic Drug Development
Steven Lynn, Executive Vice-President, Pharmaceuticals, Regulatory …
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Manufacturers Struggle with Breakthrough Drug Development
31, 2014, manufacturers submitted 140 requests for breakthrough status for drugs and biologics; the agency has approved 39 of these, approximately 30%, and denied 76. New approvals in 2013 included th…
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Predicting Progress in Protein Aggregation
As the development of biologic drugs based on antibodies and other protein/peptide molecules continues apace, the control and prevention of aggregation during manufacturing, downstream processing, for…
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Biotechnology Innovation and Growth in Israel
Key regulatory considerations
New drugs registered in Israel, including biologics, must meet European Union (EU) standard GMPs in terms of quality and efficacy to ensure public safety. In ad…
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Comparing Protein A Resins for Monoclonal Antibody Purification
Today, mAbs constitute the single largest class of biological drugs and accounts for about 36% of the total biologics market with an annual sales growth rate of approximately 10% (4).
Com…
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
… Schmid, and Michael Larson are development associates, all in the Process Development Group at CMC Biologics, http://www.cmcbio.com/.
REFERENCES
1. FDA, Draft Guidance for Industry: Target…
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Milestones and Moderate Progress in 2012 Drug Approvals
However, it was assessed and approved in the US as an original biologics license application (BLA), because a biosimilar pathway was not available to the sponsor at the time of submission to the regul…