The risk of viral contamination is acknowledged when developing biopharmaceutical products derived from mammalian-cell culture. And viral clearance and appropriate viral segregation are important factors in the manufacturing process and facility design.
Good manufacturing practice guidelines from the US FDA and the EMA emphasize that appropriate segregation of process operations is a regulatory expectation. However, the word ‘appropriate’ is undefined and open to interpretation.
This paper discusses design challenges such as how biomanufacturers often use extreme measures to segregate a post-nanofiltration operation from a cell-culture operation – but use a common glass washer or clean-in-place (CIP) skid for cleaning and sanitizing components from the two operations. The article looks at this apparent contradiction by using a mathematical model to evaluate the potential carryover/crossover risk.It aims to simplify production facilities so that a manufacturer doesn’t have multiple systems performing the same task. This means lower costs and complexity and facilities that are quicker to build and operate.