The arrangement covers process transfer, process development and GMP manufacture of affibody’s candidate.
3P Biopharmaceuticals, a leading CDMO specialized in the process development and GMP manufacturing of biologics, has signed a collaboration agreement with the Swedish company Affibody for the process transfer, scale-up and GMP commercial manufacturing of a recombinant protein sole property of Affibody.
According to the agreement, 3P is responsible for transferring and scaling up the process developed by Affibody prior to the execution of the first GMP manufacturing batches. 3P will also perform the process characterization and validation before entering the commercial batch manufacturing stage.
We are very pleased to be working with Affibody on this project and to create a strong long-term partnership with them. We are sure that this is a mutually beneficial agreement,
says Dámaso Molero,
General Manager at 3P Biopharmaceuticals.
Besides, “ensuring large scale high quality production of our ABY-035 drug is a natural next step in our evolution as a company with the ambition to have development, manufacturing, and commercialization expertise”, explained David Bejker, CEO of Affibody who added that “the work we have initiated together with 3P is important for us and we look forward to working with 3P.”
This collaboration validates the experience and know-how of 3P’s microbial services in the production of recombinant proteins. Thus, 3P, as a global manufacturing partner, has proven experience in both clinical and commercial production in E.coli included process validation and process characterization.