The manufacturing of ATMPs provides unique challenges to contamination control. Many products are manufactured at a very small scale over multiple days using a combination of open and closed processes, with many manual steps and often, due to their nature as living cellular products, without a sterilisation step. Viral vectors are used to provide the genetic material that creates, for many products, the ability to find the clinical target cells and allow the ATMP product to perform its intended function.
 
The need for specially designed facilities and processes for viral vectors and the final product is critical to allow for flexibility in operating multiple overlapping products. 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 virtual meeting will focus on microbiological challenges associated with the manufacture of these fascinating and life-changing groups of products. It will focus on CCS for facilities, viral vector, and final product manufacturing both in Europe and the US, as well as the particular challenges around operator qualification. The meeting will start by setting the scene related to the growth of the ATMP industry and the potential skills gap.  

This virtual meeting targets those working with ATMPs/Biologics or those wanting to learn more about these products. It will interest microbiologists, quality control and quality assurance professionals responsible for risk-based decision-making, and manufacturing personnel who want to upskill their microbiological knowledge around current hot topics in the manufacture of ATMPs.

Click here for more information and to register.