AGC Biologics Seattle Facility Receives Brazilian GMP Certification, Opening Access to $40 Billion South American Market
核心洞察
AGC Biologics' Seattle facility received Good Manufacturing Practices certification from Brazil's Anvisa, enabling biologics (搜索) and biosimilars (搜索) produced at the site to be commercialized in South America's largest pharmaceutical market.
The certification extends global reach for AGC Biologics customers into Brazil's $40 billion pharmaceutical market, which is projected to grow to nearly $74 billion by 2032.
The Seattle site is now cGMP-certified in 11 different countries and achieved a 100% batch success rate in 2025, demonstrating robust international manufacturing capabilities.
AGC Biologics' Seattle manufacturing facility has received Good Manufacturing Practices (GMP) certification from Agência Nacional de Vigilância Sanitária (Anvisa), Brazil's health regulatory authority, clearing the path for the company's customers to commercialize biologics (搜索) and biosimilars (搜索) in South America's largest pharmaceutical market.
The authorization represents a significant milestone for the contract development and manufacturing organization (CDMO), enabling access to Brazil's $40 billion pharmaceutical market. According to Fortune Business Insights data cited by the company, Brazil's pharmaceutical market is projected to reach nearly $74 billion by 2032, with biologics (搜索) and biosimilars (搜索) representing 40% of the market in 2024.
Global Quality Standards Achievement
"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 of Quality at 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."
The Seattle facility's certification underscores AGC Biologics' commitment to maintaining consistent global quality standards. In September 2025, the U.S. Food and Drug Administration issued a final Establishment Inspection Report confirming the Seattle site's full current Good Manufacturing Practices (cGMP) compliance.
The Seattle site now holds cGMP certification in 11 different countries, demonstrating its capability to meet diverse international regulatory standards. This achievement follows the Copenhagen facility's Anvisa GMP certification in 2023, making Seattle the second manufacturing facility in the AGC Biologics network to receive this authorization.
Operational Excellence Metrics
The Seattle facility demonstrated strong operational performance in 2025, completing 11 successful customer audits and achieving ISO 45001 and ISO 14001 certification audits with zero non-conformities. The facility also maintained a 100% batch success rate throughout the year.
"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."
Manufacturing Capabilities and Infrastructure
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. The facility features extensive adoption of single-use technologies and adherence to current International Council for Harmonisation (ICH) guidelines, ensuring rapid scale-up from clinical to commercial supply while maintaining robust cGMP compliance.
AGC Biologics achieves these regulatory and production milestones through a cohesive global quality system built on harmonized documentation, regulatory expertise, and best-practice sharing between sister sites. The shared approval status between Seattle and Copenhagen facilities can facilitate technology transfers between sites when needed.
The company's global network spans the United States, Europe, and Asia, with locations in Seattle, Washington; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan, providing world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (搜索), messenger RNA (搜索), viral vectors (搜索), and genetically engineered cells.