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. 


Copenhagen_Lab_Down_General_019_News_crop_2.jpgAGC Biologics has an impressive and successful regulatory track record. We have been successfully inspected by the US Food and Drug Administration (FDA), the Medicines and Healthcare products Regulatory Agency (MHRA), the Danish Medicines Agency (DKMA), the Paul Ehrlich Institute (PEI) and the Pharmaceuticals and Medical Devices Agency (PDMA). The frequent audits and inspections at AGC Biologics help us hone the quality of our programs and further ensure compliance.

Our US and European facilities have been issued EU commercial Good Manufacturing (cGMP) certificates. Our US site is approved by FDA for commercial cGMP production of two therapeutic protein  products.  In addition, our Copenhagen facility is approved by FDA, European Medical Authorities and Heath Canada for commercial cGMP manufacture  of a protein product.   Our facilities in Japan have been approved by the PDMA 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).


CMC_Berkeley_IPT_023_crop.jpgAt 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