Quality And Regulatory


AGC Biologics’ quality organization provides a comprehensive suite of Quality Assurance (QA) and Quality Control (QC) services. At each of our manufacturing facilities, highly trained Quality Units maintain strict quality systems to support our cGMP manufacturing efforts and to ensure compliance with all regulatory requirements.


AGC Biologics has a strong regulatory track record. We have been successfully inspected by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Danish Medicines Agency (DMA), the Paul Ehrlich Institute (PEI), Health Canada and the Pharmaceuticals and Medical Devices Agency (PMDA). The many audits and inspections conducted at AGC Biologics have helped us continuously hone our quality culture and systems and further ensure compliance.

Our US and European facilities have been issued EU commercial Good Manufacturing (cGMP) certificates. Our US site in Seattle is approved by the FDA and EMA for commercial cGMP production of two therapeutic protein products. In addition, our Copenhagen facility is approved by the FDA, EMA, HCA and PMDA for commercial cGMP manufacture of two protein products. Our facility in Japan has been approved by the PMDA for commercial manufacture of four products for the Japanese market.

We provide regulatory support to our clients for all Chemical Manufacturing Control (CMC) sections of clinical and commercial submissions. We work in partnership with clients providing support documentation for regulatory filings including Investigational New Drug (IND) applications, Biologic License Applications (BLA), New Drug Applications (NDA) and Marketing Authorization Applications (MAA).


At AGC Biologics, the enhancement and continuous improvement of Quality is the responsibility of every individual. As part of our intent focus of our customers’ compliance needs, we track new regulations and monitor and implement new regulatory trends.

Our Quality Assurance teams are dedicated to ensuring compliance with all necessary regulations and requirements.

Our capabilities and assets include:

  • Integrated quality system incorporating US, EU and ICH cGMP requirements
  • Comprehensive Quality Agreements
  • Regulatory compliance and validation expertise
  • Quality support of process validation
  • Dozens of successful client audits and regulatory inspections
  • EU GMP Certification
  • Qualified Person (QP) release of batches


AGC Biologics conducts a broad range of analytical testing that is critical to the quality of your product. The Quality Control teams are responsible for testing all aspects of product quality and facility control.

Our Quality Control capabilities include:

  • Testing of cell banks, raw materials, reference materials and other materials for cGMP production
  • In-process, intermediate and final product release testing (bulk drug substance, drug product)
  • Analytical method implementation and validation
  • Environmental monitoring of classified cGMP production areas
  • Monitoring of critical product contact utilities (WFI, HPW, clean steam and compressed air) for cGMP production
  • Handling of raw material and product reference samples
  • Analyses of samples from process and cleaning validation studies
    • Process characterization studies
    • ICH-compliant cGMP stability program (intermediates, bulk drug substance, drug product and placebo)
    • Cell-based bioassays