AGC Biologics, Flen Health Partner On Wound Treatment Development

KUALA LUMPUR, Sept 24 (Bernama) -- AGC Biologics, a global biopharmaceutical contract development and manufacturing organisation (CDMO), has been selected by Belgian biopharmaceutical company Flen Health as its CDMO partner to provide process development, scale-up and Good Manufacturing Practice (GMP) manufacturing services for a new and improved wound and skin healing product.

AGC Biologics' Heidelberg, Germany, facility will provide the next stage of development and clinical-scale manufacturing for two recombinant proteins, lactoperoxidase and glucose oxidase, the enzymatic components at the core of the wound treatment's novel mechanism of action, after cell line development was completed by myBIOS.

Following the technology transfer, AGC Biologics will conduct microbial manufacturing at 100-litre and 1,000-litre scales using the Pichia pastoris expression system in support of Flen Health’s planned Investigational New Drug submission and Phase II clinical trials, according to a statement.

AGC Biologics Heidelberg Managing Director, Dieter Kramer said the company was advancing into full GMP development and manufacturing after building on a feasibility programme initiated with Flen Health in July 2025.

Meanwhile, Flen Health Chief Executive Officer, Georges Sollie said the companies' combination of Flen Health's novel recombinant enzyme platform and AGC Biologics' manufacturing expertise would accelerate development of the new therapeutic approach.

Flaminal has been used clinically for 25 years in European markets as a topical enzyme-alginate gel for difficult-to-heal wounds. Flen Health is now advancing an improved recombinant version of the product as part of its strategic entry into the United States (US) market.

While Flen Health's Phase 0 human study will use current food-grade enzyme formulations, the strategic transition to AGC Biologics' pharma-grade recombinant enzymes will occur ahead of Phase II clinical trials, in preparation for US regulatory submissions.

In addition to Heidelberg, AGC Biologics' global microbial manufacturing network includes facilities in Copenhagen, Denmark; Seattle, USA; and Chiba, Japan.

-- BERNAMA