This Month’s Issue
The BioProcess International September 2015 issue focuses on Upstream Production. The cover features a production technician working with cell banks stored in a controlled-rate freezer from Planer plc (www.planer.com).
The BioProcess International Conference & Exposition: Pre-Event Planner.
Featuring exclusive print and audio presentation previews
Generating a stable environment for a biopharmaceutical drug substance is a critical step for ensuring a long drug-product shelf life (1–6). This process begins early in development with preformulation screening. Some of the most critical parameters to maintaining potency and activity are protein conformation (tertiary or three-dimensional (3-D) structure), folding (secondary structure), and proper subunit association (quaternary structure). Collectively, those are known as higher-order structure (HOS) and can be highly influenced by the formulation environment of a protein drug product.…