Search results for "FDA"
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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…
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Scaling Up Novel Therapies
The key to making gene therapy accessible to patients will be better manufacturing processes, Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, told attendees at the Galien …
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Best Practices for Data Integrity
In serious cases, bad data integrity could lead to an FDA-mandated shutdown of production. I’d say just about every biopharmaceutical manufacturer understands this concern. So, out of fear, they inves…
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Unifying Continuous Biomanufacturing Operations
Currently, approximately 20 FDA-approved biologic products are made using perfusion, according to a comment during INTERPHEX 2017 from Parrish Galliher, chief technology officer, upstream, at Cytiva. …
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Ensuring Sterility in Small-Scale Production
For these small-scale batches, manufacturers need to adhere to the recommended requirements for control of the environment as defined in FDA’s aseptic processing guidance (1), the Parenteral Drug Asso…
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Innovation vs. Capacity: How CMOs Compete
…ality assurance (QA) capabilities that support dependable registration and approval of new drugs at FDA and the European Medicines Agency (EMA)
• Capabilities to support clients on a global scale…
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Managing Biomanufacturing Capacity Expectations
The researchers found that demand for oncology drugs was most commonly underestimated, most likely because of the additional indications for which these drugs earned approval by FDA after initial laun…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
FDA, Memorandum: Points to Consider in Characterization of Cell Lines Used to Produce Biologics (Rockville, MD, Jul. 12, 1993).
11. FDA, Memorandum: Points to Consider in the Manufactu…