Primary source AGC Biologics: Flen Health Chooses AGC Biologics to Manufacture Recombinant Enzymes for Next-Generation Wound Treatment
Belgian biopharmaceutical company Flen Health has picked AGC Biologics as CDMO for process development, scale-up and GMP manufacturing of a recombinant wound-care product, according to a release AGC Biologics published on 24 September 2026. With cell line development by myBIOS complete, the Heidelberg, Germany site will handle the next stage of development and clinical-scale manufacturing of the two enzyme drug substances, lactoperoxidase (LPO) and glucose oxidase (GOX).
From food-grade to GMP microbial production
AGC Biologics will run microbial manufacturing of LPO and GOX at 100-liter and 1,000-liter scale using the Pichia pastoris expression system, supporting Flen Health’s planned Investigational New Drug submission and Phase II clinical trials, per the release. Flen Health partnered with myBIOS for the Pichia pastoris strain cell line development; the release describes myBIOS as specializing in methanol-free, inducible recombinant protein production using P. pastoris.
The program builds on a feasibility stage the two companies ran in Heidelberg starting in July 2025, which the release says covered comprehensive process transfer, upstream and downstream process development, analytical method implementation, and dedicated project management for the two enzyme programs.
Why the switch to recombinant matters for the process
Flen Health already sells Flaminal, an enzyme-alginate wound gel the release says has been used clinically for 25 years in European markets and is classified as a medical device made with food-grade enzymes. The company is now moving to pharma-grade recombinant LPO and GOX ahead of Phase II, a step the release ties to its strategic entry into the U.S. market. Flen Health held an INTERACT meeting with the FDA in January 2026 on its Chemistry, Manufacturing and Controls development plan, according to the release.
Georges Sollie, CEO of Flen Health, said: “By combining our novel recombinant enzyme platform with AGC Biologics’ manufacturing expertise, we are accelerating the development of a promising new therapeutic approach.” Dieter Kramer, Managing Director of AGC Biologics Heidelberg, said the program builds on the feasibility work: “That is exactly the pattern we pride ourselves on, building trust and mutual collaboration with our customers.”
AGC Biologics lists Copenhagen, Denmark; Seattle, USA; and Chiba, Japan alongside Heidelberg in its global microbial manufacturing network, per the release.
What it means for a plant
The release describes a technology transfer into a GMP microbial site after strain work at a separate partner: a feasibility stage from July 2025 covering process transfer, upstream and downstream process development and analytical method implementation, then clinical-scale manufacturing at 100 L and 1,000 L on Pichia pastoris. The release does not give titers, yields, batch counts or timelines. It links the GMP, pharma-grade drug substances to supporting classification of the product as a biologic in the United States, in place of the food-grade enzymes used in the current device. For a microbial CDMO, it is a case where the regulatory route, not only the molecule, sets the GMP and analytical scope of a program.
