By Guy Matthews, Market Development Manager, Parker Hannifin Manufacturing Ltd
Any contamination of a biopharmaceutical production process is to be avoided for obvious quality, safety, and economic reasons. However, once one occurs, the rapid detection and elimination of a contamination event is important in order to prevent further spread and higher decontamination costs. Bacterial contamination is easy to detect because there are very clear signs when it occurs, e.g., a spike in oxygen demand as the system tries to maintain the dissolved oxygen levels. Mycoplasma is potentially the most problematic form of contamination, as it is the most difficult to detect. Mycoplasma are free-living and offer no visible symptoms of contamination (although certain responses from your cell line may give an indication), making it very difficult to detect. And because detection requires special equipment and assaying techniques, a low-level Mycoplasma infection can go unnoticed for quite some time.
If a facility or process equipment is contaminated with Mycoplasma, it is notoriously difficult to resolve and can be very costly in terms of unplanned downtime, resulting in lost batches and enhanced scrutiny of processes, equipment, and products. This will ultimately affect a drug’s supply chain, which has the potential to negatively impact not just a company’s reputation but also — and most importantly — the health of patients. This makes it critical for you to understand the potential threat and sources of Mycoplasma, mitigation strategies to prevent contamination, and how application of today’s advanced technologies can optimize performance and mitigate the risks to your product and the patients it serves.