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New collaboration delivers streamlined integration from drug substance to drug product, including sterile fill-finish and device assembly for clinical programs. SEATTLE – June 30, 2026 – Drug developers have a new, optimized option for U.S.-based manufacturing, as AGC Biologics enters a strategic partnership with Pyramid Pharma Services.

In this interview with BioSpace, AGC Biologics' Anders Cai Holm Hansen,  Principal Scientist & Technical Specialist, discusses the strategies behind a flexible single-use scale-out manufacturing approach rather than the traditional scale-up method. By utilizing AGC Biologics' modular bioreactor system, Anders shares how developers can avoid major pitfalls and accelerate their path to market without having to make the expensive decision to move product to large-scale stainless steel bioreactors.

AGC Biologics to provide process development and GMP manufacturing for a novel therapy, leveraging...

Key Takeaways: Quality From Day One: Regulatory compliance is embedded into every stage of development and manufacturing to support product approval. Consistent Quality, Everywhere: Our unified global quality system delivers high standards of compliance for all products manufactured at our facilities in the U.S., Europe, and Asia. A Proven Track Record: A history of successful regulatory inspections and industry recognition demonstrate our continuous commitment to quality.

HEIDELBERG, GERMANY and CHIBA, JAPAN – May 26, 2026 – AGC Biologics, your friendly CDMO expert, was selected by Teikoku Seiyaku Co., Ltd., a leader in transdermal drug delivery, to provide microbial contract development and manufacturing services for KTP-001, a recombinant human matrix metalloproteinase-7 (rhMMP-7), to treat lumbar disc herniation. "Partnering with AGC Biologics was a clear choice.

Collaboration brings AGC Biologics’ advanced therapy expertise and global footprint to OTXL’s network, supporting a sustainable path from clinical development to commercial access for therapies serving the smallest patient populations.

Find us at Booth 4707 Date: June 22-25, 2026 Location: San Diego Convention Center in San Diego, CA Event Website: https://convention.bio.org/ Meet our team! Be sure to visit our booth or request a meeting with our team to discover how our global network and capabilities can accelerate your product to the next stage.

Successful partnership continues as bispecific antibody candidate moves to GMP manufacturing; project highlights Japan's advanced capabilities in bioprocessing and AGC Biologics' expanding global network CHIBA, JAPAN – May 4, 2026 – Novelty Nobility, a clinical-stage biotech company based in South Korea, expanded its manufacturing agreement with AGC Biologics, your friendly CDMO expert, to advance their bispecific antibody drug candidate through process development and GMP manufacturing at...

Key Takeaways: Between 2015 and 2023, 88% of novel drug approvals involved expedited review programs, requiring faster manufacturing responses. Traditional scale-up changes mixing and gas transfer parameters as vessels get larger; scale-out maintains a consistent 2,000L scale to bypass these studies. Modular single-use systems allow for rapid technology transfer across global sites and align capital investment with actual market demand.

Global CDMO recognized for exceptional quality systems and regulatory track record; named finalist in Excellence in Client Service & Partnership and Manufacturing Operations categories SEATTLE – April 27, 2026 – AGC Biologics, your friendly CDMO expert, is the 2026 recipient of the Fierce Outsourcing Award for Leadership in Regulatory and Quality Compliance. The award recognizes the company's exemplary regulatory strategy, robust quality systems, and compliance execution.