AGC Biologics announced the launch of AGCellerate, a new program designed to deliver effective IND-ready GMP material for biopharmaceutical developers, offering guaranteed amounts at fixed timelines and costs. The program supports biologics projects using monoclonal antibodies (mAbs), lentiviral vectors, adeno-associated vectors, and Plasmid DNA (pDNA). The AGCellerate mAb program offers 1.0 KG of clinical ready drug substance in 11 months, supported by AGC Biologics’ proprietary Chef-1™ platform.
AGC Biologics' white paper in collaboration with GORE discusses the development and demonstration of a high-productivity, fully single-use downstream processing platform for monoclonal antibody (mAb) production at an industrial scale, focusing on the use of Gore 1 Liter Devices to culture approximately 500 L of antibody harvest and purify it, demonstrating the feasibility of a full 2000 L batch.
MAb-solutely! New Alternative to Costly Resin Helps Antibodies Reach Clinical Milestones
AGC Biologics Partners with ATUM to Accelerate Timelines for Cell Line Development New offering provides drug developers with flexible and powerful cell line development options for monoclonal antibodies, multi-specific and complex molecules SEATTLE – Dec. 2, 2025 As drug developers face increasing pressure to lower prices and accelerate time to market, global biopharmaceutical contract development and manufacturing organization AGC Biologics is expanding its Cell Line Development Center of Excellence by partnering with ATUM to integrate the Leap-In Transposase expression platform within its offerings. This partnership provides drug developers with technology designed to increase yields and significantly shorten the path to clinical trials, directly addressing the market’s need for speed and efficiency.
Published a thought leadership blog titled 'How Modular Bioreactors Are Shortening the Path from IND to Commercial Launch' on April 27, 2026.
AGC Biologics was involved in further developing a bispecific drug candidate for Novelty Nobility.
AGC Biologics joined the Orphan Therapeutics Accelerator’s Clinical Development Network as a manufacturing partner to advance cell and gene therapies for ultra-rare diseases.
AGC Biologics announced to manufacture Teikoku Seiyaku's rhMMP-7 drug substance.
Published a thought leadership blog titled 'Quality From the Start: A Practical Approach to Regulatory Compliance and Market Success' on May 27, 2026.
AGC Biologics participated in the BIO International Convention held at the San Diego Convention Center in San Diego, CA from June 22-25, 2026, and was present at Booth 4707.
AGC Biologics featured the new AGCellerate platform for mAbs at BIO International in Boston, held at Booth #3365 - 3369 in the Contract Services Zone, from June 22-25, 2026.
AGC Biologics Expands to Fill-Finish in U.S. Through Strategic Partnership with Pyramid Pharma Services
AGC Biologics Lands Commercial Manufacturing Agreement for Yokohama Site Worth Hundreds of Millions of Dollars
Flen Health Chooses AGC Biologics to Manufacture Recombinant Enzymes for Next-Generation Wound Treatment
BIO Europe Fall - Find us at booth 8-36 - Date: November 9-11, 2026 - Location: Koelnmesse, Cologne, Germany
BIO Europe Fall
AGC Biologics announced a partnership with Child’s Cure Genetic Research to develop an mRNA-based therapeutic aimed at treating severe epileptic disorders. The collaboration seeks to leverage mRNA technology to address a critical unmet medical need. The press release was issued on November 10, 2026.
AGC Biologics announced a partnership with Child’s Cure Genetic Research to develop an mRNA‑based therapeutic for CDKL5 Deficiency Disorder, a severe epileptic condition. The collaboration aims to explore a development pathway that could bring the therapy closer to clinical use. AGC Biologics highlights its expertise in advancing mRNA programs toward the clinic.
cGMP
AGC Biologics announced a dual‑site agreement with a global pharmaceutical company, exceeding €0.5 billion. The deal expands the existing long‑term partnership by adding six commercial programs to the Copenhagen facility, while the Yokohama site continues to support five programs. It aims to consolidate high‑volume, single‑use biologics manufacturing and enhance site interoperability and dual submissions.
AGC Biologics announced that Flen Health has chosen the company to manufacture recombinant enzymes for a next‑generation wound treatment. The company also expanded its fill‑finish operations in the U.S. through a strategic partnership with Pyramid Pharma Services.
AGC Biologics has announced tech transfer initiatives, including manufacturing recombinant enzymes for next‑generation wound treatment for Flen Health and producing rhMMP‑7 drug substance for Teikoku Seiyaku. The company highlighted these projects in press releases dated September 24 and May 25, 2026.
Press Release
Flen Health has selected AGC Biologics as its CDMO partner for process development, scale-up, and GMP manufacturing of recombinant lactoperoxidase and glucose oxidase. The Heidelberg site will lead GMP development of the enzymes for Phase II clinical trials of a next-generation wound treatment.
AGC Biologics announced a commercial manufacturing agreement for its Yokohama site worth hundreds of millions of dollars.
Mammalian & mAbs