AGC Biologics’ Seattle Facility Earns Certification to Produce Biologics for Brazil’s Pharmaceutical Market
AGC Biologics Seattle Site Secures Anvisa GMP Certification for Brazilian Market Access
AGC Biologics’ Seattle manufacturing facility has achieved Good Manufacturing Practices (GMP) Certification from Agência Nacional de Vigilância Sanitária (Anvisa), Brazil’s national health regulatory authority. This important regulatory milestone authorizes biologics and biosimilars produced at the Seattle site to be commercialized in Brazil, the largest pharmaceutical market in South America. The certification significantly expands market access opportunities for AGC Biologics’ global customer base and reinforces the company’s position as a trusted contract development and manufacturing organization supporting international product launches.
Expanding Customer Access to South America’s Largest Pharmaceutical Market
Brazil represents a strategically critical market for biopharmaceutical developers, with strong demand growth across innovative biologics and biosimilars. With Anvisa certification now in place, AGC Biologics’ customers manufacturing at the Seattle site can confidently pursue commercialization in Brazil, knowing their products meet the country’s rigorous regulatory and quality expectations. This authorization not only supports near-term product launches but also strengthens long-term commercial strategies for companies seeking a foothold in South America’s rapidly expanding healthcare landscape.
Regulatory Certification Supporting Patient Access
According to Marty Shawala, Senior Vice President of Quality at AGC Biologics, the Anvisa certification directly supports patients in need of advanced therapies within Brazil. He emphasized that the approval reflects strong cross-functional collaboration across quality, regulatory, manufacturing, and operational teams throughout the AGC Biologics global network. The certification also demonstrates the organization’s ability to align quality execution with customers’ regulatory submission strategies, ensuring a smooth path from development to commercialization.
Brazil’s Biopharmaceutical Market Growth Outlook
Brazil’s pharmaceutical market is projected to experience sustained growth over the coming decade. According to Fortune Business Insights, the market is expected to reach nearly $74 billion by 2032. Biologics and biosimilars already account for a significant portion of pharmaceutical sales, representing approximately 40 percent of the market in 2024. This growth trajectory highlights why regulatory access to Brazil is increasingly important for global drug developers and underscores the strategic value of Anvisa GMP certification for AGC Biologics’ Seattle site.
Demonstrating a Consistent Global Quality Record
The Anvisa certification further reinforces AGC Biologics’ commitment to maintaining a consistent and harmonized global quality record across its manufacturing network. This approach enables customers to pursue regulatory approvals in multiple regions with confidence that quality systems, documentation, and operational practices meet diverse international standards. The Seattle facility’s latest approval builds on a long-standing track record of successful inspections and regulatory outcomes.
Strong History of International Regulatory Compliance
In September 2025, the U.S. Food and Drug Administration issued a final Establishment Inspection Report confirming the Seattle site’s full compliance with current Good Manufacturing Practices. With the addition of Anvisa certification, the Seattle facility is now cGMP-certified in 11 different countries, reflecting its ability to satisfy regulatory authorities across North America, Europe, Asia, and South America. This multi-jurisdictional compliance record is a key differentiator for customers targeting global commercialization.
Network-Wide Benefits and Technology Transfer Flexibility
The Seattle site becomes the second AGC Biologics manufacturing facility to receive GMP certification from Anvisa, following the Copenhagen site’s approval in 2023. Having multiple Anvisa-approved sites within the network provides operational flexibility and can streamline technology transfers between facilities when required. This shared regulatory status enhances supply chain resilience and supports customers navigating evolving market demands or capacity needs.
Operational Excellence Achieved in 2025
During 2025, the Seattle facility demonstrated exceptional operational performance across multiple dimensions. The site successfully completed 11 customer audits, reinforcing confidence in its quality systems and transparency. It also achieved ISO 45001 and ISO 14001 certifications with zero non-conformities, highlighting strong performance in occupational health, safety, and environmental management. In addition, the site maintained a 100 percent batch success rate, reflecting robust process control and manufacturing reliability.
A Harmonized Global Quality System
AGC Biologics’ regulatory and operational achievements are underpinned by a cohesive global quality system built on harmonized documentation, shared best practices, and deep regulatory expertise. This integrated approach allows lessons learned at one site to be rapidly applied across the network, strengthening inspection readiness and reducing regulatory risk for customers. The Anvisa certification serves as further validation of this system’s effectiveness in meeting complex international requirements.
Continued Focus on Customer Regulatory Success
Kathleen Retzloff, Senior Director of Quality for the Seattle site, emphasized that each successful inspection strengthens the organization’s readiness for future regulatory engagements. She noted that the Anvisa certification reflects both the momentum of continuous improvement efforts and the maturity of AGC Biologics’ global quality systems. The Seattle team remains focused on helping customers achieve additional regulatory approvals and expand their global reach in the year ahead.
Advanced Manufacturing Capabilities at the Seattle Campus
The Seattle facility operates within a 150,000-square-foot uniflow campus designed to support flexible fed-batch and perfusion manufacturing processes. The site also serves as AGC Biologics’ Center of Excellence for global formulation services, providing specialized expertise that supports both clinical and commercial programs. Extensive adoption of single-use technologies enables rapid changeover, scalability, and operational efficiency while maintaining stringent cGMP compliance.
Supporting Rapid Scale-Up From Clinical to Commercial Supply
By adhering to current International Council for Harmonisation (ICH) guidelines and leveraging advanced manufacturing platforms, the Seattle site enables efficient scale-up from early-stage development to commercial production. This capability is critical for customers seeking to accelerate time-to-market while ensuring consistent product quality across lifecycle stages. The Anvisa certification further validates the site’s readiness to support large-scale, globally distributed supply.
Navigating Global Regulatory Pathways Beyond FDA and EMA
AGC Biologics supports hundreds of client products through successful regulatory filings with health authorities worldwide. The Anvisa GMP certification for the Seattle site demonstrates the company’s ability to navigate the specific and rigorous requirements of diverse regulatory agencies beyond the FDA and European Medicines Agency. This expertise helps de-risk global commercialization strategies and provides customers with confidence as they pursue approvals in new markets.
Importance of a Multi-Jurisdictional Track Record
For drug developers targeting multiple international markets, partnering with a CDMO that has a proven multi-jurisdictional regulatory track record is a critical advantage. AGC Biologics’ experience with agencies including the FDA, EMA, PMDA, and Anvisa provides practical insights that help anticipate regulatory expectations, avoid common pitfalls, and reduce costly delays. This foresight contributes to a smoother and more predictable path to commercialization.
About AGC Biologics
AGC Biologics is a leading global biopharmaceutical contract development and manufacturing organization committed to delivering friendly, expert, and reliable services to clients and partners. The company provides world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA, messenger RNA, viral vectors, and genetically engineered cells. Its global network spans the United States, Europe, and Asia, with facilities in Seattle, Copenhagen, Heidelberg, Milan, and Chiba and Yokohama in Japan. AGC Biologics operates as part of AGC Inc.’s Life Science Business, which encompasses eight facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals.
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