Process development and transfer
There are many challenges in the transfer of manufacturing processes for Advanced Therapy Medicinal Products (ATMP’s) in comparison to the traditional and well proven biopharmaceutical route. Manufacturing processes for ATMP’s are typically designed in academic research environments which are neither well-documented nor developed with GMP production in mind.
Recognising these challenges, the CBC offers over 15 years’ experience to our customers in de-risking this process with a proven outcome in the successful delivery of GMP-grade products for clinical trials.
If you would like to discuss a process you would like to develop or to transfer your process to meet GMP compliance, contact one of our expert team.
We operate an industry standard cell banking system, where a master cell bank (MCB) is used to produce a working cell bank (WCB). Cell banking systems are created to ensure that a uniform population of cells are preserved, integrity is maintained and sufficient material is accessible for the lifetime of the product. Clones that have been established are cryopreserved to minimise contamination, degradation and genetic variation; passaging is kept to a minimum.
All of our cell banking is performed in a dedicated GMP cell banking area. We can work with a bacterial line of your choice, or can provide recommendations on a suitable strain for your project.
For more information, please contact an expert member of our team