Improving The Lives of Patients

FAQs

• What CDMO services does AGC Biologics provide?

  AGC Biologics is a global Contract Development and Manufacturing Organization (CDMO) offering services from pre-clinical to commercial stages. We offer mammalian and microbial based biologics, cell therapies, messenger RNA (mRNA), plasmid DNA (pDNA), viral vectors that support both cell and gene therapies, and support Antibody-Drug Conjugates (ADCs). We parnter with you from early clinical development work, through all phases of clinical trials and commercial-scale cGMP manufacturing. 
  
  

• Where are AGC Biologics' global manufacturing facilities located?

  We operate a global network of cGMP-compliant facilities across three continents. Our sites span U.S., Europe, and Asia with sites in Seattle (US), Copenhagen (Denmark), Heidelberg (Germany), Milan (Italy), Chiba (Japan), and Yokohama (Japan). This network allows us to serve as a local partner with global capabilities that can help you develop and produce your drug product as close as possible to the patient population you are wanting to reach. 

• What cell line development (CLD) services do you offer?

  AGC Biologics offers comprehensive cell line development for both mammalian and microbial systems. For mammalian programs, we utilize the CHEF1™ Expression System and the latest in transposase technologies to deliver high-titer, stable cell lines for mAbs and complex proteins. We utilize advanced screening technologies to identify the most productive clones rapidly, reducing the timelines for creating a working and reliable cell bank and reaching phase I clinical cGMP manufacturing.  For microbial programs, we utilize proprietary E. coli and Pichia pastoris expression systems to achieve high product yields.

• Which regulatory agencies has AGC Biologics successfully inspected with?

  Our global facilities maintain a strong track record of 90+ successful inspections by major regulatory bodies, including the FDA (USA), EMA (Europe), PMDA (Japan), Health Canada, TFDA (Taiwan), ANVISA (Brazil), The Danish Medicines Agency (DMA), MFDS (Korea), and more. This global compliance ensures your product meets the rigorous quality standards required for international markets. 

• Do you provide analytical development and quality control (QC) testing?

  Yes, we integrate analytical development and quality control throughout the product lifecycle. From early-stage assay development to commercial release testing and stability studies, our teams ensure the safety, potency, and purity of every batch we manufacture. 

• What are the benefits of using single-use bioreactors in manufacturing?

  Single-use bioreactors (SUBs) and single-use systems minimize cross-contamination risks and significantly reduce turnaround times between batches, while also helping you to better manage market needs and scale-out (adding more bioreactors) if demand calls for it. AGC Biologics utilizes single-use bioreactors across our mammalian and viral vector networks to offer flexible, speed-to-market solutions for clinical and commercial supply. Learn how we mitigate risks.

• How does AGC Biologics accelerate timelines for drug development?

  We utilize established platform processes, such as our BravoAAV™ and ProntoLVV™ platforms for viral vectors, and the ATUM Leap-In Transposase® technology for mammalian cell line development, to reduce development time significantly. These pre-optimized platforms allow partners to move rapidly from gene sequence to cGMP manufacturing without sacrificing quality or safety.