Flen Health chooses AGC Biologics to manufacture recombinant enzymes for next-generation wound treatment. Heidelberg site to lead GMP development of lactoperoxidase and glucose oxidase for Phase II clinical trials. HEIDELBERG, Germany, Sept. 24, 2026 (GLOBE NEWSWIRE) - Belgian biopharmaceutical company Flen Health has selected AGC Biologics as their CDMO partner to provide process development, scale-up, and GMP manufacturing services for a new and improved wound and skin healing product. Manufacturing Services to Support Regulatory Submissions, Clinical Trials "We're thankful Flen Health has entrusted us with this next chapter." "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..." "As we now advance into full GMP development and manufacturing, we are building on a successful feasibility program we initiated with Flen Health in July..." With cell line development from myBIOS complete, AGC Biologics' Heidelberg, Germany facility will partner for the next stage of development and clinical-scale manufacturing of two recombinant proteins, lactoperoxidase and glucose oxidase, the enzymatic components at the core of the wound treatment's novel mechanism of action. Following the technology transfer, AGC Biologics will conduct microbial manufacturing at 100-liter and 1,000-liter scale using the Pichia pastoris expression system, in support of Flen Health's planned Investigational New Drug submission and Phase II clinical trials. A Novel Combination Product Flaminal(R) has been used clinically for 25 years in European markets as a topical enzyme-alginate gel for difficult-to-heal wounds. Classified as a medical device, the therapeutic approach combines a recombinant enzyme system within an alginate matrix to accelerate wound healing. Flen Health is now advancing an improved, recombinant version of the product as part of its strategic entry into the U.S. market, which has seen limited changes to the chronic and acute wound care sector in recent years. Addressing a Serious Diabetes Complication Diabetic foot ulcers remain one of the most undertreated complications in chronic wound care, affecting up to 25% of diabetic patients in their lifetime with an annual cost of $13 billion to the US healthcare system. Diabetic foot ulcers are the leading cause of lower extremity amputations among people with diabetes, accounting for about 85% of such procedures. 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. Effective wound repair in DFUs is challenged by disrupted cell communication, impaired inflammatory responses, and a hostile healing environment. The Next Chapter for Enzyme-based Wound Therapies While Flen Health's Phase 0 human study will utilize current food-grade enzyme formulations, the strategic transition to AGC Biologics' pharma-grade recombinant enzymes will occur ahead of Phase II clinical trials, applying deep expertise in a world-class GMP facility in preparation for U.S. regulatory submissions. "Patients with diabetic foot ulcers need better treatment options," said Georges Sollie, CEO of Flen Health. "By combining our novel recombinant enzyme platform with AGC Biologics' manufacturing expertise, we are accelerating the development of a promising new therapeutic approach." "As we now advance into full GMP development and manufacturing, we are building on a successful feasibility program we initiated with Flen Health in July 2025. That is exactly the pattern we pride ourselves on, building trust and mutual collaboration with our customers," said Dieter Kramer, Managing Director, AGC Biologics Heidelberg. "We're thankful Flen Health has entrusted us with this next chapter." In addition to the Heidelberg location, AGC Biologics' global microbial manufacturing network includes facilities in Copenhagen, Denmark; Seattle, USA; and Chiba, Japan. Frequently Asked Questions (FAQs): Will the recombinant LPO/GOX product require a traditional IND, a device submission, or some other regulatory coordination with the FDA? Flen Health participated in an INTERACT meeting with the FDA in January 2026 to receive feedback on their Chemistry, Manufacturing, and Controls development plan. This enables them to prepare for an IND submission. How does the new recombinant version differ from the current Flaminal product? The current Flaminal product on the market utilizes food-grade enzymes within an alginate environment to effectively treat difficult-to-heal wounds and accelerate the healing process. With the new recombinant version, AGC Biologics will manufacture the lactoperoxidase and glucose oxidase drug substances to GMP and pharma-grade standards to support classification of the product as a biologic in the United States. Does AGC Biologics provide strain development? AGC Biologics offers full strain development for Escherichia coli expression systems. For this program, Flen Health partnered with myBIOS to provide Pichia pastoris strain cell line development. myBIOS specializes in methanol-free, inducible recombinant protein production using P. pastoris, enabling safer, more sustainable, and cost-efficient manufacturing. myBIOS supports customers in strain engineering and early-stage process development, while its myPICHIA(R) platform provides a comprehensive toolbox for in-house protein production. AGC Biologics has experience working with partners to provide process development for multiple expression system host cells (E. coli, P. pastoris with or without methanol induction, Pseudomonas fluorescens, Bacillus, and Lactobacillus casei). What did the feasibility program launched in July 2025 include: strain screening, cell-line development, fermentation, purification, formulation, analytics, or all of these? The feasibility stage conducted at the AGC Biologics site in Heidelberg for Flen Health included comprehensive process transfer, upstream and downstream process development, analytical method implementation, and dedicated project management for recombinant lactoperoxidase and glucose oxidase programs. By focusing on optimizing fermentation, purification, and analytical frameworks, this strategic partnership lays a solid groundwork for future wound and skin healing solutions. Will AGC Biologics support CMC documentation for the IND, including process descriptions, analytical methods, specifications, validation plans, and stability data? Similar to other customer programs, AGC Biologics will support all required regulatory documentation for the IND submission, building on best practices developed through other submissions and providing its regulatory expertise at every stage. What is the regulatory history of the AGC Biologics Heidelberg site? AGC Biologics has a strong regulatory track record. The 100+ successful audits and inspections conducted at AGC Biologics help the CDMO continuously hone its quality and compliance culture and systems. The AGC Biologics Heidelberg site has received regulatory approvals from agencies such as the FDA, EMA, and PMDA. Heidelberg's inspection history over the last ten years includes routine inspections from the FDA and Germany's Regierungspräsidium Tübingen, all with no critical or major findings. About Flen Health Flen Health is a biopharmaceutical company dedicated to developing innovative therapies for unmet needs in wound care. Founded in 2000 and headquartered in Kontich, Belgium, the company has more than 25 years of experience delivering trusted wound and skin healing solutions across Europe and in more than 40 countries worldwide. Flen Health is now leveraging this expertise to bring its novel therapeutics to the U.S. market. For more information, visit www.flenhealth.com. About AGC Biologics AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as Dixon Mitchell work side-by-side with its clients and partners, to provide friendly and expert services. Dixon Mitchell provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Its global network spans the U.S., Europe, and Asia, with locations in Seattle, Washington; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. AGC Biologics is a part of AGC Inc.'s Life Science Business. The Life Science Business runs eight facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com.

AGC Biologics lands commercial manufacturing agreement for Yokohama site worth hundreds of millions of dollars. Wednesday, July 29, 2026 Ahead of the official opening of AGC Biologics' Yokohama site, an international biopharmaceutical company has already secured half of the facility's mammalian manufacturing capacity with a multi-year commercial contract expected to reach hundreds of millions of dollars in total value. The Contract Development and Manufacturing Organization (CDMO) will leverage its new Yokohama facility to manufacture a minimum of 35 batches per year of five biopharmaceutical products for the undisclosed customer, securing a reliable global supply chain for patients worldwide. The agreement includes process transfer, scale-up, regulatory validation, and future commercial production. The customer will pursue multiple regulatory approvals with the EMA, FDA, MHRA, and PMDA. The aggressive manufacturing timeline includes four process performance qualifications (PPQ) campaigns in the first two years. Securing commercial production in Japan reflects a broader industry shift toward supply chain resilience, as global biopharmaceutical developers increasingly prioritize established, geopolitically stable manufacturing partners with locations that mitigate geopolitical, regulatory and trade risks. "AGC Biologics has the largest global network of single-use manufacturing capacity by volume outside of China, but that's not the full story," said Alberto Santagostino, President and CEO of AGC Biologics. "The market is demanding capable, reliable manufacturing partners with global quality standards and geographic flexibility. This agreement reflects the strength of our network, our single-use expertise, and the strategic role Japan can play in resilient biologics supply chains. Our newest Japan site in Yokohama synthesizes all our network learning in a location of increasing interest, and that carries the intrinsic cultural value of manufacturing quality and effective delivery." Once operational in 2027, the Yokohama site will deploy four 2,000-liter Cytiva single-use bioreactors and two 5,000-liter Thermo Fisher Scientific DynaDrive single-use bioreactors, adding 18,000 liters to AGC Biologics' existing capacity of single-use technology for biologics manufacturing. Select customers and guests are scheduled to be provided with the opportunity to visit the new site in December 2026, when construction is completed. "Securing a major commercial partner for Yokohama before the site is operational is a strong signal of confidence in what this facility will offer," said Tadashi Murano, President of AGC Life Science Company. "With the site located adjacent to the AGC Yokohama Technical Center, biopharmaceutical developers are understanding that choosing a CDMO with an established innovation ecosystem in Japan is a smart outsourcing strategy." The AGC Biologics' Yokohama site was part of the biomanufacturing investments made by Japan's Ministry of Economy, Trade and Industry in 2022. These strategic investments are designed to expand domestic production and reinforce Japan's position as a highly trusted, long-term biologics partner for life sciences industries within allied nations. Services available in Yokohama starting in 2027 will include: * Mammalian development and GMP manufacturing, with two downstream lines and flexible single-use bag capacity of 18,000 liters. * Cell therapy services with six clean rooms. * Messenger RNA (mRNA) development and manufacturing with 2 IVT, two purification lines, and two LNP lines. With existing cGMP manufacturing locations in the U.S., Japan, and Europe, AGC Biologics' track record will help kick off the manufacturing operation in Yokohama, utilizing the experience of: * More than three decades of GMP experience. * 100 successful regulatory inspections. * More than 30 commercial products launched, which received more than 100 separate regulatory agency approvals. * More than 400 products developed and manufactured for over 250 different customers. About AGC Biologics AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as Pharma Focus Asia work side-by-side with its clients and partners, to provide friendly and expert services. Pharma Focus Asia provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Its global network spans the U.S., Europe, and Asia, with locations in Seattle, Washington; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. AGC Biologics is a part of AGC Inc.'s Life Science Business. The Life Science Business runs eight facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com.