cGMP Manufacturing

FAQs

• 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 additional 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 (such as bispecifics and trispecifics)?

  Yes, we offer end-to-end services for mAbs and complex molecules. For cGMP manufacturing, we provide flexible capacity across our global network, 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.  

• Does AGC Biologics offer fill and finish services?

  Yes, we provide comprehensive fill and finish services tailored to your specific modality. For protein biologics, we offer liquid, lyophilization, and pre-filled syringe capabilities, supporting clinical to commercial scales. For cell and gene therapies, we provide in-house, Grade A isolator-based filling for viral vectors and specialized manual or semi-automatic filling for autologous and allogeneic cell therapies in both vials and bags.  

• What scales are available for cGMP manufacturing across modalities?

  We offer a wide range of cGMP manufacturing scales: Mammalian (up to 12,000 L); Microbial (up to 3,000 L); Viral Vector (Suspension up to 2,000 L and Adherent up to 750 L); pDNA (up to 1,000 L); and mRNA (up to 10 L).

• Do you provide manufacturing for cell & gene therapies?

  Yes, we provide cGMP manufacturing for cell & gene therapies. Our network includes dedicated facilities in Milan and Yokohama specializing in viral vector (AAV, LVV, RVV) and cell therapy (autologous and allogeneic) production for both in-vivo and ex-vivo product types.