Our practices are inspired by GMP guidance to offer a seamless transfer of your process
The transfer of a robust production process from a non-GMP to a GMP environment is a pivotal step in process development for therapeutic proteins and antibodies. It is key to anticipate the handover, whether internal or from a CRO to a CMO.
GTP strives to ensure a smooth process development that will put you in the best position for a successful clinical phase.
Since starting our process development activities, we have worked in close partnership with several CMOs and consultants to ensure methods, procedures, equipment and records match cGMP manufacturing expectations.
Our track record of successful process transfers testifies that GTP offers the expected level of process expertise
From the very initial steps, we will focus our attention on the future transfer, selecting a recognised and productive (IP-free wherever possible) expression system, familiar to CMOs. During the process development, we will offer guidance on the choice of CMO based on their expertise and capacity, then align as much and as early as possible with the CMO’s practices.
Our advanced procedures for transfer and close relationships with some cGMP manufacturers make the transfer from GTP to CMO companies no more risky than an internal transfer within any CMO from R&D laboratories to 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.