Authorization clears the way for customers to enter Brazil’s $40 billion pharmaceutical market 

The Seattle facility of AGC Biologics, your friendly CDMO expert, has received a Good Manufacturing Practices Certification from Agência Nacional de Vigilância Sanitária (Anvisa), Brazil’s health regulatory authority. The authorization allows biologics and biosimilars produced at the site to be commercialized in Brazil, the largest pharmaceutical market in South America, further extending the global reach of AGC Biologics’ customers.

“This certification ensures that our customers are able to deliver product to patients in need of treatment in the Brazilian market,” said Marty Shawala, Senior Vice President, Quality, AGC Biologics. “It reflects how our teams work collaboratively across departments and throughout the network to meet required quality standards and maintaining the business strategy associated with our customer’s regulatory submission.”

According to a report from Fortune Business Insights, Brazil’s pharmaceutical market is poised to grow to nearly $74 billion in 2032, with biologics and biosimilars representing 40% of the market in 2024.

A consistent global quality record

This achievement underscores AGC Biologics' commitment to maintaining a consistent, global quality record that helps partners secure regulatory approval in key markets.

• In September 2025, the U.S. Food and Drug Administration issued a final Establishment Inspection Report confirming the Seattle site's full cGMP compliance.
• The Seattle site is now a cGMP-certified facility in 11 different countries, demonstrating its ability to meet diverse international standards.
• Seattle is the second manufacturing facility in the AGC Biologics network to receive GMP certification from Anvisa, with the Copenhagen site receiving GMP certification from the agency in 2023. This shared approval status can facilitate tech transfers between sites when needed.

In 2025, the Seattle facility completed:

• 11 successful customer audits
• ISO 45001 and ISO 14001 certification audits with zero non-conformities
• a 100% batch success rate

AGC Biologics achieves these regulatory and production milestones with a cohesive global quality system built on harmonized documentation, regulatory expertise, and best-practice sharing between sister sites.

Company focused on delivering additional regulatory approvals for customers

“With every inspection, our team becomes more prepared for the next, and this Anvisa certification is a testament to that momentum as well as the strength of our global quality systems,” said Kathleen Retzloff, Senior Director of Quality for AGC Biologics’ Seattle site. “We are laser-focused on helping our customers achieve even more regulatory success in the year ahead.”

The 150,000-square-foot uniflow campus in Seattle supports flexible fed-batch and perfusion processes and serves as AGC Biologics’ Center of Excellence for global formulation services. With extensive adoption of single-use technologies and adherence to current ICH guidelines, the Seattle site of AGC Biologics ensures rapid scale-up from clinical to commercial supply while maintaining robust cGMP compliance.

AGC Biologics Anvisa GMP Certification FAQ

How does AGC Biologics ensure global regulatory success for its partners beyond just the FDA and EMA?

As a dedicated CDMO partner, AGC Biologics guides hundreds of client products through successful global filings with a wide range of global health authorities. This recent GMP certification from Brazil's Anvisa for a product manufactured at its Seattle facility demonstrates expertise in navigating the specific and rigorous requirements of diverse international markets, de-risking the path to global commercialization for partners.

What does this Anvisa approval say about the capabilities of AGC Biologics’ Seattle facility?

For drug developers, an approval from a rigorous agency like Brazil's Anvisa confirms that the quality systems and operational teams at the Seattle facility are robust enough to meet diverse global expectations, not just those of one or two authorities. This gives clients confidence that their product is manufactured to a consistently high standard, suitable for reliable worldwide supply.

For a drug developer targeting multiple international markets, why is a 'multi-jurisdictional' track record like this important?

A drug developer's primary goal is to get their therapy to patients efficiently and safely. A partner with a proven multi-jurisdictional track record is a powerful asset in achieving this. AGC Biologics' experience with agencies like the FDA, EMA, PMDA, and now Anvisa, provides practical, firsthand knowledge of what it takes to succeed globally. This foresight is brought to every client project to help avoid common pitfalls and costly delays, ensuring a smoother, more predictable journey to commercialization.

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 eight facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com.

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The authorization allows biologics and biosimilars produced at the site to be commercialized in Brazil, the largest pharmaceutical market in South America, further extending the global reach of AGC Biologics’ customers.