Search results for " regulators"

Article Automation Trend in Fill/Finish Reduces Contamination Risk
Aseptic fill/finish is crucial in biopharma manufacturing and is optimized through automated technology. By Feliza Mirasol  Aseptic filling is a crucial process in biopharmaceutical …

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…

Article 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…

Article The New World of Biopharmaceutical Manufacturing
Industry experts discuss the single-use revolution and changes to upstream and downstream processing equipment. By Jennifer Markarian …

Article From Darwin to Recombinant Fc Multimers
Topics from a Darwinistic viewpoint on how business models are evolving in the Life Science industry to breakthrough research data from Momenta Pharmaceuticals on a recombinant trivalent Fc protein …

Article Witnessing Major Growth in Next-Generation Antibodies
Problems observed with early CAR T-cell therapies with respect to overly aggressive immune responses have led regulators to require treatments that involve immune responses be started at very low dose…

Article Ensuring Sterility in Small-Scale Production
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses how to ensure sterility when manufacturing small-scale parenteral batches. By Susan J. Schniepp Q. I am a …

Article Evaluating E&L Studies for Single-Use Systems
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials. By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni Biop…

Article Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
The year ahead is expected to be marked by increased biosimilar development, lower drug prices, and better quality drugs. The global biopharmaceuticals market was valued at $162 billion in 2014 a…

Article 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…

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