Recognised for Regulatory and Quality Excellence
AGC Biologics has been awarded the 2026 Fierce Outsourcing Award for Leadership in Regulatory and Quality Compliance. This honour acknowledges the company’s outstanding regulatory strategy and robust quality systems. Announced on April 14, the award ceremony will take place during Fierce Biotech Week in Boston, Massachusetts, on May 13.n
Boasting a strong track record in regulatory success, AGC Biologics has conducted over 100 successful inspections and received more than 30 commercial product approvals. In 2025, regulatory inspections at AGC Biologics were carried out by seven global health authorities, resulting in five new product approvals for partners.n
CEO and President Alberto Santagostino expressed gratitude towards the regulatory agencies and stated, “We are humbled and grateful for the rigor of regulatory agencies around the world that help us in our journey of continuous quality improvement.”n
Expanding Global Operationsn
Expanding its global operations, AGC Biologics is constructing a new facility in Yokohama, Japan. This state-of-the-art site will feature one of the largest single-use bioreactors for a CDMO in Japan. Services will 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 two IVT, two purification lines, and two LNP lines.n
Yokohama’s new site aims to enhance AGC Biologics’ capabilities in delivering high-standard services across continents, ensuring consistent quality and compliance. Strengthening a resilient supply chain with limited geopolitical risk is a primary goal.n
Across three continents, AGC Biologics provides unified, high-quality services focused on consistency and excellence, regardless of project complexity or location. The company’s technical expertise is supported by over three decades of industry-leading GMP experience, having worked with more than 400 products for over 250 different customers.n
The Fierce Outsourcing Awards, formerly known as the Fierce CRO Awards, celebrate outsourcing partners that play a crucial role in helping pharmaceutical and biotech companies advance rapidly, manage risks, and bring innovative therapies to patients. This awards programme recognises excellence, innovation, and impact across the outsourced drug development ecosystem.n
AGC Biologics was also a finalist in the Excellence in Client Service & Partnership and Manufacturing Operations categories. This recognition celebrates the company’s commitment to excellence, innovation, and impactful contributions across the outsourced drug development ecosystem.
Last updated: 28 April 2026, 5:19 am
