- Flen Health has selected AGC Biologics as its CDMO partner for process development, scale-up, and GMP manufacturing of a new recombinant wound and skin healing product.
- AGC Biologics’ Heidelberg facility will manufacture two recombinant proteins, lactoperoxidase and glucose oxidase, at 100-liter and 1,000-liter scales to support planned regulatory submissions and Phase II clinical trials.
Flen Health has selected AGC Biologics as its contract development and manufacturing organization (CDMO) partner to provide process development, scale-up, and GMP manufacturing services for a new and improved wound and skin healing product. The work will support Flen Health’s planned Investigational New Drug submission and Phase II clinical trials as the Belgian biopharmaceutical company advances the product toward the US market.
Following completion of cell line development by myBIOS, AGC Biologics’ Heidelberg, Germany facility will take on development and clinical-scale manufacturing of two recombinant proteins, lactoperoxidase and glucose oxidase. The proteins are the enzymatic components at the core of the wound treatment’s mechanism of action. Following technology transfer, AGC Biologics will conduct microbial manufacturing at 100-liter and 1,000-liter scales using the Pichia pastoris expression system.
The product is an improved recombinant version of Flaminal, a topical enzyme-alginate gel that has been used clinically in European markets for 25 years to treat difficult-to-heal wounds. Flen Health is advancing the recombinant version as part of its strategic entry into the US market. The company said its Phase 0 human study will use current food-grade enzyme formulations, with the transition to pharma-grade recombinant enzymes planned ahead of Phase II clinical trials.
The program is focused on wound healing, including diabetic foot ulcers (DFUs), which Flen Health identifies as a serious complication of diabetes and chronic wound care. The company said DFUs can be difficult to repair because of disrupted cell communication, impaired inflammatory responses, and a hostile healing environment.
“Patients with diabetic foot ulcers need better treatment options. By combining our novel recombinant enzyme platform with AGC Biologics’ manufacturing expertise, we are accelerating the development of a promising new therapeutic approach.”
Georges Sollie, CEO of Flen Health
AGC Biologics said the collaboration builds on a feasibility program initiated with Flen Health in July 2025.
