Search results for " regulations"
Article
Automation Trend in Fill/Finish Reduces Contamination Risk
Handling sterile liquids in the pharmaceutical industry has traditionally relied on consistent techniques over the past 100 years, and changes in technology and regulations have been relatively slow, …
Article
Reliability Rooms and the Move to Proactive Supply Chain Management
Reliability Rooms and the Move to Proactive Supply Chain Management
Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict tren…
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Automated In-Line Buffer Preparation from Ready-Made Stock Solutions in a mAb Process Step
Buffer preparation is both time-and space-consuming and can easily become a challenge in biomanufacturing. This application note describes a lean approach to buffer preparation by implementing in-li…
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The New World of Biopharmaceutical Manufacturing
Industry experts discuss the single-use revolution and changes to upstream and downstream processing equipment.
By Jennifer Markarian
…
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From Darwin to Recombinant Fc Multimers
Uwe Schlenkrich, publisher of Hemophilia News, presented the patient perspectives on the industry and the regulations, especially how the German healthcare system affects patients’ lives. Another pres…
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Witnessing Major Growth in Next-Generation Antibodies
Including next-gen antibodies in pharma pipelines is considered essential for future success.
By Cynthia A. Challener
Next-generation antibodies are designed to be more specific and are ofte…
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Ensuring Sterility in Small-Scale Production
The best advice is to consult the regulations and determine what requirements you must meet to help ensure the clinical material you are manufacturing is safe.
Clinical-trial material batches can …
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Evaluating E&L Studies for Single-Use Systems
FDA, Code of Federal Regulations 21 Part 211.65 and §211.94.
3. BPOG, Standard Extractables Protocol for Biopharmaceutical Single Use Systems and Components, www.biophorum.com/.
4. D. …
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Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
Despite the advent of regulations and technical capabilities, market leaders at Interphex 2016 expressed their confidence to Process Development Forum that continuous processing, ripe with innovation,…
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Drug Quality Key to Innovation and Access
FDA plans to advance initiatives for ensuring reliable production of drugs and biologics in 2017.
By Jill Wechsler
Amidst multiple challenges to the structure and governance of the US health…