Build your biopharma development and manufacturing knowledge base with the latest whitepapers, application notes, posters, and other educational resources from biopharma industry suppliers.

Are You Ready for USP <800>?

April Cloutier

Download this application note to learn about hazardous drugs basics - listing through storage, engineering controls and training programs, and why you shouldn’t wait, regardless of initial enforcement for your facility.

Challenging Microbial Sanitization of a Liquid Chromatography System

Chelsea Pratt, PhD

To ensure that no contaminating or hazardous residual components remain after protein purification during biologic development, additional sanitization steps may be required for the instrumentation utilized during these processes.

Purification of Antibodies with Hydrophobic Anion Exchange Resin

Jared Isaac, Eric Bishop and Ken Hoffman

A new hydrophobic anion exchange mixed-mode resin has been developed to overcome existing challenges in antibody purification. Described here are two case studies on the purification of an acidic and a basic antibody in bind-elute and flow-through modes. The results demonstrate the ability of this resin to improve process productivity and economy.

Protein A Resin to Reduce Production Costs

This report details how using high capacity TOYOPEARL AF-rProtein A HC-650F resin will reduce production costs, on a per-gram produced basis.

Understanding 21 CFR Part 11/Annex 11 Compliance

Tony Perovsek

Learn how regulators define temporary memory and how to maintain data integrity. Find out what to look for in a LIMS for 21 CFR Part 11 and Annex 11 compliance.