Risk-based strategies for viral safety assurance
Regulatory agencies expect cell therapy product manufacturing processes to have viral safety and contamination risk control strategies in place to ensure patient safety.
Viral safety measures involve an orthogonal approach that focuses on preventing, detecting, and clearing potential viral contaminants. Regulatory authorities expect these measures to be implemented without negatively affecting product quality and safety. However, for cell therapy products, the available options are limited due to their unique nature. Therefore, sponsors of cell therapy products must primarily rely on prevention and detection strategies rather than on clearance methods.
Currently, there is limited guidance specific to viral safety for cell therapies, resulting in uncertainty regarding the required viral safety strategies for these treatments.
To address this issue, a collaboration of chemistry, manufacturing, and controls (CMC) experts in cell therapy manufacturing—13 participants from eight organizations, including Horst Ruppach and Kerstin Brack from Charles River—has undertaken a review of current viral safety regulations and guidance. They have discussed critical viral safety aspects in the manufacturing process of cell therapy products and developed a risk assessment template and structure to evaluate and mitigate risks, using chimeric antigen receptor T-cell (CAR-T) products as an example.