GMP-like practices for seamless production transfers
Transferring a robust production process from a non-GMP to a full-fledged GMP environment is a pivotal step in the development of your therapeutic proteins and antibodies. Getting it right is key to the handover, whether the process development is handled internally or transferred by a CRO to a CMO.
GTP ensures smooth process development to put you in the best position for a successful clinical phase.
Ever since we started developing production processes for recombinant proteins and antibodies, we have worked in close partnerships with a range of CMOs and consultants to validate methods, procedures, equipment and records and make sure records match cGMP manufacturing expectations.
Custom production processes to lower risk
Right from the start of your recombinant protein and antibody production project, the GTP team focuses on the upcoming transfer. During production process development, we generally select a recognized and productive (IP-free whenever possible) expression system that most CMOs are familiar with. We also offer guidance the CMO's choice, based on their expertise and know-how. We align as closely and as early as possible with the chosen CMO’s practices.
Our advanced transfer procedures and close relationships with cGMP manufacturers reduce the risk of transferring your project to CMO companies. The transfer becomes no more risky than an internal transfer inside a CMO company between the R&D team and the cGMP manufacturing suite.
Our track record for successful handovers to a diversity of CMO companies in recent years gives the assurance that we can transfer the processes we develop to the cGMP manufacturing site of your choice.