AGC Biologics Wins 2026 Fierce Outsourcing Award for Leadership in Regulatory and Quality Compliance

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 (GLOBE NEWSWIRE) -- 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. Winners were announced by the Fierce Outsourcing Awards organizers on April 14 and will be celebrated during Fierce Biotech Week in Boston, Mass., on May 13.

Delivering Quality Services Across Three Continents to Bring High-Quality Products to Patients

Through globally integrated operations, AGC Biologics provides unified, high-quality services, focused on consistency and excellence regardless of a project's complexity or geographic location. AGC Biologics’ technical expertise is backed by more than three decades of industry-leading GMP experience, 100 successful regulatory inspections, more than 30 commercial product approvals, and experience with more than 400 products for over 250 different customers.

“In 2025, our sites collectively underwent nine successful regulatory inspections from seven different global health authorities, resulting in five new product approvals for our partners,” said Alberto Santagostino, CEO and President of AGC Biologics. “We are humbled and grateful for the rigor of regulatory agencies around the world that help us in our journey of continuous quality improvement.”

Continued Investment in Excellence and Global Quality with New Site in Japan

Demonstrative of AGC Biologics’ continued investment in global quality, a state-of-the-art facility is currently under construction in Yokohama. This new site will offer one of the largest single-use bioreactors for a CDMO in Japan, extending AGC Biologics’ tri-regional footprint of uniform, high-standard service delivery, exceptional quality and compliance, resilient supply chain, and limited geopolitical risk.

Services in Yokohama include mammalian development with two downstream lines and flexible single-use bag capacity of 18,000 liters, cell therapy services with six clean rooms, and mRNA development and manufacturing with 2 IVT, two purification lines, and two LNP lines.

What the Fierce Outsourcing Awards Represent

The Fierce Outsourcing Awards, formerly the Fierce CRO Awards, recognize outsourcing partners that play a critical role in helping pharma and biotech companies move faster, manage risk, and bring innovative therapies to patients.

This awards program celebrates excellence, innovation, and impact across the outsourced drug development ecosystem—honoring the organizations that deliver scientific rigor, operational excellence, and trusted partnership at every stage of the pipeline. Entries were judged on the ability of the applicant to demonstrate the following: innovation and impact, measurable outcomes, sustainability and scalability, and ethical and regulatory adherence.

In addition to receiving the award for leadership in regulatory and quality compliance, AGC Biologics was also named a finalist for categories recognizing exceptional and collaborative client service, and superior performance in manufacturing regarding quality, consistency, and operational excellence across modalities.

FAQs

What specific factors establish AGC Biologics as a leader in regulatory and quality compliance for pharmaceutical outsourcing?

AGC Biologics' leadership in regulatory and quality compliance is established by a long and consistent history of global regulatory success and a deep commitment to quality systems. Key factors that demonstrate this leadership include:

• Extensive GMP Experience. With over 30 years of industry-leading GMP manufacturing experience, AGC Biologics’ processes are built on a foundation of proven quality and technical expertise. Robust regulatory and quality frameworks have directly contributed to more than 30 commercial product approvals for partners, proving the CDMO’s ability to successfully navigate the path to market.
• Proven Inspection Success. AGC Biologics has a track record of more than 100 successful regulatory inspections from health authorities worldwide. In 2025 alone, AGC Biologics sites successfully completed nine inspections from seven different global health authorities, underscoring its continuous state of compliance.
• Diverse Portfolio and Broad Trust. AGC Biologics’ experience spans more than 400 products for over 250 different customers, reflecting the industry's trust in its ability to manage a wide array of complex biologics while upholding the highest standards. This extensive portfolio has resulted in five new product approvals for partners in 2025.
  

How does AGC Biologics’ global, unified quality system directly benefit biopharma developers and ensure project success?

Leadership in regulatory and quality compliance is evidenced by a proven history of successful product approvals. AGC Biologics' global network consistently delivers results that meet the stringent requirements of regulatory bodies worldwide, which biopharma developers need in order to test their therapies and ultimately enter new commercial markets.

A successful global, unified quality system begins with a deeply embedded quality culture, a fact corroborated by client testimonials of AGC Biologics. Fondazione Telethon directly credits the “high-quality services provided by AGC Biologics” as instrumental in achieving both FDA approval and a positive CHMP opinion for Waskyra™. Similarly, Autolus, upon receiving FDA approval for its first product, highlighted AGC Biologics as a "valued manufacturing partner... providing reliable, high-quality and timely support.”

In just the last two years, the Seattle site helped shepherd four product approvals by the FDA and eight product approvals in other regulatory jurisdictions. These outcomes are a direct result of a quality system that is robust, globally integrated, and relentlessly focused on client success.

What other recognition has AGC Biologics received for its quality track record?

Last year, AGC Biologics received the Best Quality Management Systems Award at the CDMO Leadership Awards for its global quality system across its sites on three different continents.

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 we work side-by-side with our clients and partners, to provide friendly and expert services. We 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. Our 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 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com.

Media Contact:

AGC Inc. corporate contact: info-pr@agc.com   
AGC Biologics media contact: kati.sills@agc.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0a890f59-3a79-42da-afe8-e540449c58e5