In Shared clean-in-place systems: To share or not to share? and How much harm can a single droplet do? Considerations for a viral inactivation step, BioPhorum’s Drug Substance Closed Systems in CNC workstream addressed viral segregation of manufacturing steps relating to the purification process. In this follow-up paper, published by BioProcess International, the workstream looks more closely at viral contamination risks related to perhaps the most susceptible unit operation, namely the cell cultivation step where viral amplification can occur.
Manufacture of biopharmaceuticals using mammalian cells inherently has a risk of viral contamination during the cell cultivation step. If introduced, viruses have the potential to infect and replicate inside the cells used to produce a therapeutic protein or a vaccine. The consequences of such contaminations are dramatic, including the loss of the contaminated batch, extensive root cause investigations, facility clean-up and introduction of preventive measures. These issues can result in significant economic and capacity consequences.
The paper presents a case study based on an actual incident, where a source of viral contamination was not identified during the initial risk assessment of the manufacturing process. It illustrates that even in carefully controlled environments, sometimes things can go wrong. Once the risk was realized, mitigations were immediately and effectively put in place preventing recurrence. While the paper discusses these mitigations, the primary aim is to direct the focus of the reader to the necessity of a 360° risk identification of the manufacturing process: prevention is better than cure. Learning from mistakes is always painful, learning from the mistakes of others is much less painful and underlines the value of sharing this type of information. By sharing such events, our industry may benefit from the hard-earned experiences of individual companies.