AGC Biologics Honoured For Leadership In Regulatory, Quality Compliance

KUALA LUMPUR, April 28 (Bernama) -- AGC Biologics, a global biopharmaceutical contract development and manufacturing organisation (CDMO), has won the 2026 Fierce Outsourcing Award for Leadership in Regulatory and Quality Compliance.

Winners were announced by the Fierce Outsourcing Awards organisers on April 14 and will be celebrated during Fierce Biotech Week in Boston, Massachusetts, on May 13, according to a statement.

The award recognises outsourcing partners that help pharmaceutical and biotechnology companies accelerate development, manage risk and bring innovative therapies to patients, with AGC Biologics recognised for its regulatory strategy, robust quality systems and compliance execution.

“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.

“We are humbled and grateful for the rigour of regulatory agencies around the world that help us in our journey of continuous quality improvement,” said AGC Biologics Chief Executive Officer and President, Alberto Santagostino.

AGC Biologics said its quality track record includes more than 100 successful regulatory inspections, over 30 commercial product approvals, and experience supporting more than 400 products for over 250 customers.

Through globally integrated operations, the company provides unified, high-quality services focused on consistency and excellence regardless of project complexity or geographic location.

Demonstrating continued investment in global quality, a state-of-the-art facility is under construction in Yokohama and will offer one of the largest single-use bioreactors for a CDMO in Japan.

The new site will extend AGC Biologics’ tri-regional footprint of high-standard service delivery, quality compliance and supply chain resilience. Services at the facility will include mammalian development with two downstream lines, flexible single-use bag capacity of 18,000 litres, and cell therapy services.

AGC Biologics was also named a finalist in categories recognising exceptional and collaborative client service, as well as superior manufacturing performance in quality, consistency and operational excellence across modalities.

-- BERNAMA