PDA Southeast Chapter Webinar - A Strategy for Contamination Control of Cellular Therapy Manufacture

TA Strategy for Contamination Control of Cellular Therapy Manufacture Sponsored by EcoLab Life Sciences Presenter - Donald C. Singer, Senior Microbiology Technical Consultant, N.A. for Ecolab Life Sciences

Cell therapy production involves continuous, stepwise, aseptic processing over multiple days, thus the emphasis on controls should be placed on microbial contamination prevention and detection. A risk-based approach to microbial contamination monitoring and control is a recommended best practice. This integrates identifying and mitigating risk associated with potential contamination due to bacteria, fungi, and mycoplasma. Risk assessments should be used to justify alternative approaches for cell therapy manufacture instead of only using those specified in classical pharmaceutical GMPs.

Most cell therapy manufacturing processes employ steps that are time-sensitive, therefore a risk-based approach must also ensure a successful and timely treatment of the patient.