Collaboration to Modernize CHO Virus Safety Testing and Establish a Virus Risk Assessment Framework
The current CHO Bioprocess virus testing approach does not reflect the wealth of knowledge gained over the last 30+ years of process and product histories and the current state of analytical testing capability. The time is right to modernize the industry’s understanding of virus risks to CHO Bioprocesses, as well as approaches to mitigate those risks, based on a comprehensive risk assessment and application of modern testing capabilities. Conversely, new, and emerging biotechnology products are using cell lines for which the biopharmaceutical manufacturing industry has much less experience with regards to viral safety. For these new products, a risk assessment methodology to guide companies in determining which viruses are the biggest risks to products manufactured with those cell lines would be valuable.
The project team will be performing a comprehensive assessment of viral risk to CHO cells, leveraging the industry’s decades of experience, and using that exercise to establish a framework to guide companies in assessing the viral risks to new and emerging cell lines.