The manufacturing of ATMPs provides unique challenges to contamination control. Many products are produced in small batches over several days, utilizing both open and closed processes with multiple manual steps, often because they are living cellular products that require no sterilization. Other products are manufactured on a larger scale; however, because their production involves culturing biological materials, they have a higher risk of contamination. The consequences of a contamination event can be extremely significant to the patient and the manufacturer.

The need for specially designed facilities and processes for manufacturing products is critical to allow for flexibility in operating multiple overlapping products, and this complexity increases during product development from early clinical phases to commercialization. In all cases, a comprehensive and well-considered Contamination Control Strategy (CCS) is necessary to integrate the various controls required to ensure that products are microbiologically controlled and free from contamination.

This meeting will focus on microbiological challenges associated with the manufacture of these fascinating and life changing group of products with focus on dealing with scale up through product development, how a robust and effective CCS can help minimise risk product manufacturing both in Europe and US, how and limitations of using rapid microbiological testing methods for these products as well as the particular challenges around aseptic process simulations and operator qualification.

The meeting is open to anyone working with ATMPs/Biologics or interested in learning more about them.  It will be of interest to microbiologists, quality control, and quality assurance professionals responsible for risk-based decision making, as well as manufacturing personnel who want to upskill their microbiological knowledge around current hot topics in the manufacture of ATMPs.

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