Heidelberg, Germany, September 24, 2026
Flen Health has selected AGC Biologics as its contract development and manufacturing organization (CDMO) partner to support the development and GMP manufacturing of recombinant enzymes for a next-generation wound and skin healing treatment. AGC Biologics’ Heidelberg facility will provide process development, scale-up, technology transfer, and GMP manufacturing for recombinant lactoperoxidase and glucose oxidase, two enzymes central to Flen Health’s proposed therapeutic approach. The manufacturing program is being developed to support a planned U.S. Investigational New Drug (IND) submission and Phase II clinical trials.
AGC Biologics to Manufacture Recombinant Enzymes
Following completion of cell-line development by myBIOS, AGC Biologics will advance the manufacturing program at its Heidelberg facility. The company will conduct microbial manufacturing at 100-liter and 1,000-liter scales using a Pichia pastoris expression system. The work will follow a previous feasibility program initiated with Flen Health in July 2025, which included process transfer, upstream and downstream process development, analytical method implementation, and project management for the recombinant enzyme programs. The two recombinant proteins, lactoperoxidase (LPO) and glucose oxidase (GOX), form the enzymatic components of the wound-treatment product’s proposed mechanism of action. AGC Biologics will transition the program toward pharma-grade and GMP-compliant manufacturing, supporting the quality and Chemistry, Manufacturing, and Controls (CMC) requirements needed for future regulatory submissions. The company will also provide regulatory documentation support associated with the planned IND submission.
Recombinant Technology Targets Difficult-to-Heal Wounds
Flen Health has developed Flaminal®, a topical enzyme-alginate gel that has been used clinically in European markets for approximately 25 years to treat difficult-to-heal wounds. The existing product uses food-grade enzymes within an alginate matrix. Flen Health is now developing an improved recombinant version as part of its strategy to enter the U.S. market with a product intended to address significant challenges in chronic and acute wound care. The new recombinant approach is particularly relevant to diabetic foot ulcers (DFUs), a serious complication of diabetes associated with chronic, difficult-to-heal wounds. Flen Health notes that diabetic foot ulcers can affect a substantial proportion of people with diabetes during their lifetime and are a major contributor to lower-extremity amputations. Impaired inflammatory responses, disrupted cellular communication, and the wound environment can all complicate the healing process, creating a need for additional treatment approaches.
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GMP Manufacturing Supports Phase II Development
The transition from food-grade enzymes to recombinant, pharma-grade enzymes represents an important development step for Flen Health’s U.S. regulatory strategy. The company participated in an FDA INTERACT meeting in January 2026 to obtain feedback on its CMC development plan, supporting preparation for a future IND submission. The recombinant version is being developed with the intention of supporting classification of the product as a biologic in the United States, according to AGC Biologics. Flen Health’s current development plan includes a Phase 0 human study using existing food-grade enzyme formulations, followed by the strategic transition to AGC Biologics’ recombinant enzymes ahead of Phase II clinical trials. This staged development approach allows the company to progress its clinical research while establishing a scalable GMP manufacturing process for later-stage development and regulatory requirements.
AGC Biologics’ Heidelberg site will contribute its expertise in microbial manufacturing, process development, analytical development, regulatory support, and GMP production. The site has experience with multiple microbial expression systems and has undergone regulatory inspections and approvals involving agencies including the FDA, EMA, and PMDA. The collaboration represents a significant manufacturing milestone for Flen Health as it advances its recombinant enzyme-based wound therapy toward U.S. clinical development. By combining Flen Health’s wound-care technology with AGC Biologics’ manufacturing capabilities, the companies are working to establish the production infrastructure needed for future clinical trials and regulatory submissions. Further clinical development will determine the safety and efficacy of the recombinant product in patients with difficult-to-heal wounds.
Source: Flen Health, AGC Biologics press release
