Mammalian
Manufacturing

FAQs

• What scales are available for mammalian cGMP manufacturing?

  AGC Biologics offers flexible manufacturing scales to support products from clinical phases to commercial production. Our capabilities utilize single-use bioreactors (SUBs), specifically our 6Pack™ System, which enables us to run up to six 2,000 L SUBs simultaneously to allow flexible production scales (2,000-12,000 L). We have successfully manufactured over 150 mammalian cell culture-based products and launched 9+ commercial products.  

• What are the benefits of using single-use bioreactors in mammalian 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 (add 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.

• Do you provide cGMP manufacturing for monoclonal antibodies (mAbs) and atypical molecules (ex: Trispecifics)?

  Yes, we offer end-to-end services for mAbs and complex molecules. For cGMP manufacturing, we provide flexible capacity across our global network (Seattle, Copenhagen, Chiba), featuring single-use bioreactors (up to 2,000 L) and our 6Pack™ System (scaling up to 12,000 L) to support clinical through commercial supply. We also utilize the ATUM Leap-In Transposase^® technology and our proprietary CHEF1^™ Expression System to generate high-titer, stable cell lines for standard and atypical molecules.  We have the unique ability to take a molecule - regardless of its complexity - and help you build a process that gets it to its next clinical milestone. We also are known for supporting commercial programs at scales and timelines needed to meet market demand. 

• What is the CHEF1™ Expression System?

  The CHEF1™ Expression System is our proprietary mammalian platform using CHO cells, optimized for rapid development of stable cell lines. It is a commercially proven platform used to produce 5 commercial products, offering a royalty-free model with no milestone fees to provide a cost-effective solution for our partners. 

• What is the ATUM Leap-In Transposase^® technology?

  The Leap-In Transposase^® technology, offered through our partnership with ATUM, is a cutting-edge platform that stably integrates DNA into a host cell's genome. It enables the rapid generation of high-titer, genetically stable cell lines, significantly shortening development timelines for monoclonal antibodies and complex biologics by allowing for the use of stable pools that are predictive of the final clone performance. 

• 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. 

• Do you offer commercial production for mammalian biologics?

  Yes, we have extensive commercial manufacturing experience. We have successfully manufactured over 150 mammalian cell culture-based products and have launched 9+ commercial products into the market. 

• Do you offer services for antibody drug conjugates (ADCs)?

  Yes, through our Proveo™ partnership, we offer integrated end-to-end services for ADCs. This includes the development and manufacturing of the monoclonal antibody, partnership for the payload and conjugation, and final fill/finish.