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.

Both our US and European facilities have been issued EU commercial Good Manufacturing (cGMP) certificates. Our US site is commercially approved by the US Food and Drug Administration (FDA) for commercial GMP production of a protein therapeutic product and recently completed a successful pre-approval inspection (PAI) for a second product.  In addition, our Copenhagen facility completed successful pre-approval inspections by FDA and the European Medical Authorities in 2015 and is awaiting approval of this product.

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 conduct surveillance of 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