Belgian biopharma company Flen Health has picked AGC Biologics as their contract development and manufacturing organization (CDMO) in support of Flen’s planned Investigational New Drug submission and Phase II clinical trials for an improved, recombinant version of its Flaminal medical device — a therapeutic approach combining a recombinant enzyme system within an alginate matrix to accelerate wound healing.   

AGC Biologics, a Seattle-headquartered CDMO, will provide process development, scale-up, and GMP manufacturing services. AGC’s Heidelberg, Germany facility will be involved in the next stage of development and clinical-scale manufacturing of two recombinant proteins — lactoperoxidase and glucose oxidase — which are the enzymatic components at the core of the wound treatment’s novel mechanism of action.

Once technology transfer is accomplished, AGC will conduct microbial manufacturing at 100-liter and 1,000-liter scale using the Pichia pastoris expression system. In addition to the Heidelberg facility, the CDMO’s global microbial production network includes sites in Chiba, Japan, Copenhagen, Denmark, and Seattle.

“Patients with diabetic foot ulcers need better treatment options,” Georges Sollie, CEO of Flen Health, said in a statement. “By combining our novel recombinant enzyme platform with AGC Biologics’ manufacturing expertise, we are accelerating the development of a promising new therapeutic approach.”

Globally, 10.2% of the population are living with diabetes and the prevalence of the disease continues to rise, increasing the risk of non-healing foot ulcers and further straining healthcare systems, according to the announcement. The strategic transition to AGC Biologics’ pharma-grade recombinant enzymes will occur ahead of Phase II clinical trials in preparation for U.S. regulatory submissions.