Search results for " FDA"
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
…hat 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
Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in the development of biosimilars.
By Feliza Mirasol
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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
…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…