LONG READHarmonizing the industry and improving confidence through risk-based microbial testingThe integrity of...
Closed systems: How much harm can a single droplet do? Considerations for a viral inactivation step
This paper discusses a systematic approach to assessing virus segregation measures, which can help biopharmaceutical developers achieve sufficient segregation for the low-pH inactivation steps in their downstream processes. It covers a process description, mathematical modeling, failure modes and the effects on viral clearance, and the importance of proper design.
Without appropriate segregation of their operations, biomanufacturers run the risk of carryover contamination from previous process steps or product batches, and the risk of crossover contamination between product(s) made in the same facilities. Using BioPhorum’s risk-based virus segregation strategy, not only will companies understand how to mitigate these risks, but they will also potentially reduce costs by having a less complicated process and gain a much clearer understanding of their system and design.