Process development is a highly complex task, requiring custom-developed solutions for every cell product. Successful process development can, therefore, only be achieved through the application of extensive experience and expertise in all aspects of GMP manufacturing and ATMP quality control.
A deep understanding of all aspects of ATMP pharmaceutical development is the foundation of effective process development. First-hand experience of working with regulators, and robust quality management must underpin the whole GMP process development, ensuring its compatibility with the various applicable regulatory requirements. If not performed properly, this dimension can be a major stumbling block in the successful transfer to the clinic of otherwise promising medical products.
apceth Biopharma offers clients its proven expertise in GMP process development for different types of ATMPs to help bridge the gap between the research bench and the patient as safely – and quickly – as possible. A robust GMP production process and a consistent batch-to-batch quality are thereby guaranteed.
apceth Biopharma ensures that all relevant regulatory requirements are met and that approval is granted by the various authorities. This area includes attainment of GMP manufacturing licenses according to the European ATMP Regulation (EC) No. 1394/2007 and German Medicines Act for the ATMP in question.