GTP simultaneously ensures high quality production of protein material for your in vivo studies and the development of a process that is readily scalable and transferable to a cGMP environment.
In most protein development programmes, once the PoC studies are successful, the next critical step is the rapid supply of protein material to perform in vivo safety and activity studies.
Drawing on our experience over more than 50 projects for therapeutic and agrichemical applications, we have developed significant expertise in the development of decagram scale production processes for preclinical and toxicology studies.
Timing is often critical in these projects, as is having the expected material at the exact right time to fit into your schedule for in vivo trials.
Through training, adequate equipment and practice, we have developed an agile organisation which offers the flexibility needed to match your timelines. We can therefore integrate new projects typically with a week’s notice and have developed project management frameworks suitable for fast track development.
Our pilot production facilities include a range of fermenters, bioreactors and downstream equipment sized for decagram quantities.
We also offer a comprehensive range of characterisation methods and analytical development services and have the early stage formulation competencies to design a customised package for your protein.
The methods and platforms used when developing the process for your recombinant protein are identical to those used by most CMOs, for a cost-effective and seamless transfer to the cGMP manufacturing suite of your choice.