ATMP’s and Microbiological Related Issues
Thursday 16th May ½ day virtual meeting
13.00 – 17.15 (BST)
Via Zoom
The manufacturing of ATMP’s 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 natures 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 it’s intended function.
The need for specially designed facilities and processes for viral vectors and final product is critical to allow for flexibility in being able to operate multiple overlapping different 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 meeting will focus on microbiological challenges associated with the manufacture of these fascinating and life changing group of products with a focus on CCS for facilities, viral vector and final product manufacturing both in Europe and US as well as the particular challenges around operator qualification.
The meeting will start by setting the scene related to growth of the ATMP industry and potential skills gap.
The meeting is targeted to those working with ATMP’s/Biologics or those who wish to learn more about these products. 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.
Please click here to view the full current agenda and booking form
