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 is why BioPhorum’s Closed Systems in CNC workstream has started publishing a series of articles to help manufacturers use science- and risk-based approaches to address viral segregation challenges. This is so manufacturers can make data-driven decisions and answer questions such as, “What are the risks involved in a process?” and “Do we need to spend a lot of money on three systems or can we use a single one?”
The first in the series, Shared Clean-in-Place Systems: To Share or Not to Share? has now been published by BioProcess International.
It 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.
The particular paper 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.
Future pieces will look at different aspects of viral segregation. The next article covers viral inactivation and whether one or two tanks are needed for this process step. The final piece covers the need to consider the impact of procedural controls on top of physical segregation within a facility.
Understanding the risks in their systems allows manufacturers to make sounds design decisions that can withstand scrutiny. How ‘appropriate’ are your systems?