Avoid Surprises With Comprehensive Cell Line Characterization

By Kathryn Martin Remington, Ph.D.

A robust strategy for viral safety assurance is an essential component of every biopharmaceutical manufacturing process and typically consists of three pillars: prevent, detect, and remove. Prevention includes measures to keep contaminants from entering the process, and includes careful selection and testing of raw materials. Detection involves testing in-process materials for contaminating adventitious agents, and removal encompasses different steps in downstream purification that inactivate or remove viral contaminants. This white paper focuses on the characterization of cell lines, a cornerstone of the “prevent” pillar, and is critical to stopping the entry of contaminants, including viruses, into the manufacturing process.