Search results for " FDA" in Articles / App Notes
Article
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
…uality 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 scal…
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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
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Also, if producing at commercial scale, which regulatory standard is needed? Is the product approved by FDA, the European Medicines Agency (EMA), the China FDA, Brazil’s National Health Surveillance A…
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Tools for Continuous Bioprocessing Development
In 2008, FDA rejected Genzyme’s application to produce Myozyme in a 2000-liter-scale facility under the same approval authorization given for its 160-liter-scale plant. The FDA ruling stated that the …
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Implications of Cell Culture Conditions on Protein Glycosylation
The authors present a review of the techniques commonly used for glycosylation analysis.
By Michiel E. Ultee, PhD, Dr. Richard Easton
This article reviews the implications of cell-culture co…