AGC Biologics Seattle Site Certified to Manufacture Biologics for Brazil Market

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

Feb. 4, 2026 at 2:47am

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The Seattle facility of AGC Biologics, a leading global biopharmaceutical CDMO, has received a Good Manufacturing Practices Certification from Anvisa, Brazil's health regulatory authority. This 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.

Why it matters

This certification demonstrates AGC Biologics' commitment to maintaining a consistent, global quality record that helps its partners secure regulatory approval in key markets. It also underscores the company's ability to meet diverse international standards, which is crucial for drug developers targeting multiple international markets.

The details

The Seattle site is now a cGMP-certified facility in 11 different countries, and it is the second AGC Biologics manufacturing facility to receive GMP certification from Anvisa, after the Copenhagen site 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, and achieved a 100% batch success rate.

  • In September 2025, the U.S. Food and Drug Administration issued a final Establishment Inspection Report confirming the Seattle site's full cGMP compliance.
  • In 2023, the Copenhagen site of AGC Biologics received GMP certification from Anvisa.

The players

AGC Biologics

A leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service.

Anvisa

Brazil's health regulatory authority that issued the Good Manufacturing Practices Certification to AGC Biologics' Seattle site.

Marty Shawala

Senior Vice President, Quality at AGC Biologics.

Kathleen Retzloff

Senior Director of Quality for AGC Biologics' Seattle site.

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What they’re saying

“This certification ensures that our customers are able to deliver product to patients in need of treatment in the Brazilian market.”

— Marty Shawala, Senior Vice President, Quality

“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.”

— Kathleen Retzloff, Senior Director of Quality

What’s next

AGC Biologics is focused on delivering additional regulatory approvals for its customers to help them achieve even more regulatory success in the year ahead.

The takeaway

This certification from Brazil's Anvisa demonstrates AGC Biologics' expertise in navigating the specific and rigorous requirements of diverse international markets, which is crucial for drug developers targeting multiple global markets and helps de-risk the path to worldwide commercialization for the company's partners.