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Top Stories
In a productive year, 2017 was filled with acquisitions, facility expansions, and new biopharma technology.
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Attracting and retaining qualified bio/pharma experts demands a mix of recognition, rewards, and opportunities.
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Industry News
A survey by LNS Research and sponsored by Honeywell showed that industrial companies are not moving quickly to adopt cyber security; calls on CEOs to take action.
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The agency has posted a warning letter to companies promoting Coco Loko, a snortable chocolate powder, and Legal Lean, a drink, as substitutes for street drugs.
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Supplier News
The new 30,000-L, $150-million biologics manufacturing facility in Wuxi, China, quintuples the company’s existing manufacturing capability.
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The company is expanding its 380,000-square-feet Molex Little Rock facility to include a FDA-registered manufacturing center of excellence for connected health and drug-delivery devices.
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Bio/Pharma News
Gilead Sciences will acquire Cell Design Labs to further cell-therapy research and development efforts.
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FDA has accepted for review Eli Lilly and Company’s biologic drug candidate that is in development for treating migraine.
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Regulatory News
The agency has approved Nucala (mepolizumab) to treat Eosinophilic Granulomatosis with Polyangiitis (EGPA) to GlaxoSmithKline. This indication is the first FDA-approved therapy specifically to treat EGPA.
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An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing.
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Process Validation
Rinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.
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Dosage Forms
Orbis Biosciences’ Optimµm Platform delivers microparticulate dosage forms with controlled-release and taste-masked properties in a single manufacturing step.
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Analytics
In Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets.
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Supply Chain
Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict trends and areas for improvement.
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Events
February 7–8, 2018
February 11–14, 2018
February 20–22, 2018
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eBOOKS
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New technologies, including single-use systems, are leading the push for faster production and higher titers. At the same time, ensuring quality in raw materials and water systems, and controlling contamination are paramount. In this Biologics and Sterile Manufacturing eBook, the editors explore key technology, process, and operational topics. |
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