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. 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.
