Viruses are the real tough guys of biology.
We all saw how difficult it was to run a fight with a contagious virus on the loose. In the absence of vaccines, the best we could do was to stay away from them.
When making biopharmaceuticals we walk many extra miles to avoid viral contamination in the first place- because all it takes is one such infective particle to destroy an entire batch and shut off the manufacturing line for a long period of time.
So we start as early as the initial cell banks (attention early phase startups!), as they would carry over any latent viruses into all our future manufacturing runs, and we continue well into the routine- by carefully selecting raw materials and implementing specific measures into the process such as heat, pH, solvents, nanofiltration, and chromatography, to reduce the risk....
And it doesn’t end there- like anything else, we need to validate this aspect, but we cannot simply spike viruses into our manufacturing equipment and see what happens. We develop validated scale-down models of the commercial process and spike them in specialized labs.
ICH Q5A has been revised recently to acknowledge the vast industry experience and prior knowledge in this space, and to include new analytical technologies that have been developed since its first inception 24 years ago- but the overall paradigm remains largely the same, and viral safety remains one of the most challenging aspects in CMC development.
In session 3 of the CMC Essentials Training Course, we will discuss Viral safety and Sterility Assurance of biological products... join us!