Pre-GMP Manufacture of Recombinant ProteinsPublished on June 12, 2018
While OET is currently unable to offer GMP manufacture of recombinant proteins or viruses, we can offer a premium service for pre-GMP manufacture. This can serve as a very useful bridge to full GMP projects conducted by other service providers. So what is the advantage of a pre-GMP step?
It really boils down to cost. Some of our own R&D is moving in the direction of needing GMP but we have been shocked at the prices quoted to us. However, what can help to reduce these costs is if a large amount of the work performed to generate a virus or a protein has been done to the same level of record keeping as is required for GMP. Experts in running GMP facilities take great delight in telling you that GMP actually stands for Great Mountains of Paperwork! There is truth in their humour as work at this level does require extensive but necessary record keeping. Even in an electronic age this is usually done with pen and paper. Basically, everything you do is recorded – even which reagent and wipes you use to clean your class II cell culture hood.
So if you have a target that you think may progress to GMP at a later date, it can be worth having it made at the pre-GMP standard. OET can accomplish this for you. We have done it for previous customers and are currently doing it for one of our own R&D projects to generate a vaccine for Crimean Congo haemorrhagic fever virus (CCHFv). This latter project is funded by a recent award to OET from Innovate UK. The costs may be a little higher owing to the record keeping required, but it will give you a head start if and when you move your project to GMP manufacture. It is certainly cheaper than having your whole project done at GMP level!
Contact OET Ltd for more details of this service.