Affibody has selected Biovian Oy as a CDMO partner for ABY-062 recombinant protein for clinical trial use.
The agreement covers the technical transfer of production processes and analytics followed by non-GMP and GMP manufacturing of the ABY-062 molecule at Biovian’s facility in Turku, Finland. Analytical method validations, aseptic fill and finish of Drug Product as well as stability studies are also covered under the service agreement.
A long-term collaboration
The ABY-062, which is part of Affibody’s broad pipeline, is a protein antibody mimetic with superior characteristics surpassing monoclonal antibodies (mAbs) and antibody fragments. This project is a continuum of Affibody’s and Biovian’s long-term collaboration.
“We are looking forward to continuing our collaboration with Biovian with the manufacturing of our new drug candidate. During our more than 10 years of partnership, their team has demonstrated strong commitment and ability to meet our expectations both in terms of time and quality. I am confident that selection of Biovian for manufacturing of ABY-062 will enable Affibody to reach the project and business goals,” says David Bejker, CEO of Affibody.