Thursday 4th September 2025 ½ day virtual meeting – 13.30 – 16.30 (BST) – Via Zoom
NHS Member Fee £200 (Join Now) / NHS Non-Member Fee £300
The manufacturing of ATMP’s provides unique challenges to contamination control. Many products are produced in small batches over several days, using both open and closed processes with multiple manual steps, often because they are living cellular products without sterilisation. 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 product is critical to allow for flexibility in being able to operate multiple overlapping different products and this complexity increases during product development from early clinical phases to commercialisation. In all cases a comprehensive and well considered Contamination Control Strategy (CCS) is needed to bring together the many controls needed to ensure 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 for anyone working with ATMPs/Biologics or interested in learning 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 ATMP’s
