Affibody AB, a Swedish biotech company focused on developing next-generation biopharmaceuticals has selected Biovian Oy, the leading Nordic One-Stop-Shop CDMO for biopharmaceuticals 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. 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.
David Bejker, CEO of Affibody commented:
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.
Knut Ringbom, CEO of Biovian added:
We are proud that Affibody once again, has selected us as the partner for their valuable program. Ever since our company was founded in 2003, we have been dedicated to providing CDMO excellence in biopharmaceutical manufacturing. Biovian’s expertise in scale-up and GMP manufacturing will be essential to the successful manufacturing of Affibody’s novel therapeutic protein candidate ABY-062 for clinical trials.
Affibody is a clinical-stage biopharmaceutical company with a broad product pipeline focused on developing innovative bi- and multi-specific next-generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody® molecules and Albumod™. The company operates a focused experimental medicine model and currently has two clinical-stage programs. The first is a therapeutic program that targets psoriasis. The second program is a diagnostic imaging program that is directed primarily towards metastatic breast cancer. Affibody AB is a holding of Patricia Industries. Additional information is available at: https://www.affibody.se/
Biovian is a Contract Development and Manufacturing Organization, CDMO that provides premium services to biotech companies developing innovative gene therapies or biopharmaceuticals. The goal of the company is to turn ideas into products by taking client projects from the laboratory bench to the clinic. Biovian offers its clients One-Stop-Shop GMP CDMO services, with modularity available from gene to finished vial. Biovian is especially focusing on Viral Vector production and microbial production of recombinant proteins and GMP plasmid DNA. Guided by its Nordic ethos Biovian has established a reputation for delivering high-quality work on time and within budget to a global client base. Additional information is available at: https://biovian.com/