Viral risk mitigation for Mammalian cell culture media
1Amgen, Inc., 4000 Nelson Road, Longmont, CO 80503.
Abstract:
Adventitious viral contamination in mammalian cell culture manufacturing facilities can lead to loss of product due to regulatory concerns regarding potential health risks. These events can also result in manufacturing shutdowns for extended periods of time. Numerous measures are currently taken to minimize these risks. Nonetheless, raw materials remain a high-risk entry point for viral contamination of mammalian cell cultures. Two virucidal technologies, ultraviolet radiation in the C band and high-temperature short-time pasteurization, were tested for the treatment of mammalian cell culture media. The results demonstrated no impact to the cell culture process or the quality of the products produced at the chosen dosage while providing robust viral protection.
Insights
Raw materials can introduce viruses into mammalian cell cultures, risking product loss. Ultraviolet (UV-C) radiation and high-temperature short-time pasteurization effectively inactivate viruses in cell culture media without harming product quality.
Area of Science:
- Biotechnology
- Cell Culture Technology
- Viral Safety
Background:
- Adventitious viral contamination poses significant risks in mammalian cell culture manufacturing, potentially leading to product loss and manufacturing shutdowns.
- Raw materials are identified as a critical entry point for viral contamination in these sensitive manufacturing processes.
- Current risk mitigation strategies are in place, but the vulnerability associated with raw materials necessitates further investigation.
Purpose of the Study:
- To evaluate the efficacy of two virucidal technologies, ultraviolet C (UV-C) radiation and high-temperature short-time (HTST) pasteurization, for treating mammalian cell culture media.
- To determine if these treatments impact the cell culture process or the quality of the final product at effective viral inactivation dosages.
- To assess the potential of these technologies in mitigating viral contamination risks originating from raw materials.
Main Methods:
- Mammalian cell culture media was subjected to treatment with UV-C radiation.
- Mammalian cell culture media was subjected to treatment with HTST pasteurization.
- The treated media was subsequently used in mammalian cell cultures, and the impact on the cell culture process and product quality was analyzed.
Main Results:
- Both UV-C radiation and HTST pasteurization demonstrated robust viral inactivation capabilities in mammalian cell culture media.
- The chosen dosages for both virucidal technologies showed no adverse impact on the mammalian cell culture process.
- Product quality was maintained, with no negative effects observed on the final products manufactured using the treated media.
Conclusions:
- UV-C radiation and HTST pasteurization are effective methods for virucidal treatment of mammalian cell culture media.
- These technologies offer a viable solution for mitigating viral contamination risks associated with raw materials without compromising manufacturing processes or product integrity.
- Implementing these virucidal treatments can enhance the safety and reliability of mammalian cell culture manufacturing.
