11.09.24 -- Bioprocess Online Best Of October

The FDA has issued a revised version of its guidance, Control of Nitrosamine Impurities in Human Drugs. This article explores the agency's recommendations, root causes of nitrosamines, and strategies for mitigating their presence in pharmaceuticals.

Industry still struggles to manage complex data requirements, which forced the FDA to once again delay enforcement of the Drug Supply Chain Security Act.

BioPlan's 21st annual survey finds that downstream processing capacity constraints are at their lowest reported in years.

Explore how one organization built upon 15+ years of experience and an extensive knowledge base of biologics manufacturing to establish commercial-scale ADC manufacturing capabilities.

Standardization and flexibility in aseptic filling were thought to be mutually exclusive. But what if there was a standardized system with flexibility built into the aseptic process, so you didn’t have to choose?

Although polymer bags are an excellent choice for cold chain use, not all polymer films perform the same way, even if their specifications rate them for use at low temperatures.

No matter how robust and consistent your assays are today, the time will come when a tech transfer, a scale-up, a supplier change, a partnership deal, or some other force of change requires an analytical methods transfer. You should be preparing for that day. Join Bioprocess Online Live on December 3rd for best practices to ensure the methods you're developing today are seamlessly transferrable tomorrow. Registration is free thanks to the support of BD Bioscience.