Viral clearance is fundamental to viral safety for biopharmaceutical products and regulators require biomanufacturers to have appropriate segregation of their operations.
Unfortunately, in the absence of a clear definition of “appropriate”, biomanufacturers must interpret regulatory expectations and define their own virus reduction and segregation strategies. The result is a wide range of approaches adopted by different companies, e.g. for the low-pH viral inactivation step, some companies use a two-vessel design, while others use only one.
This is why BioPhorum’s Closed Systems in CNC Workstream has written a paper called How Much Harm Can a Single Droplet Do? Considerations for a Viral Inactivation Step.
It 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.
Published by BioProcess International, it is the second article in a series on virus segregation strategies to be considered when designing a biopharmaceutical facility. The first article in the series discussed the potential for cross-contamination from clean-in-place systems used across a number of multi-use systems. The final article will cover the need to consider the impact of procedural controls on top of physical segregation within a facility.