Global Cell & Gene Therapy CDMO Services 

FAQs

• What types of viral vectors does AGC Biologics manufacture?

  We specialize in the development and manufacturing of adeno-associated virus (AAV), lentiviral vectors (LVV), and retroviral vectors (RVV). Our platforms, including BravoAAV™ and ProntoLVV™, allow us to significantly improve timelines and are optimized for suspension or adhesion-based processes to support the growing needs of the cell and gene therapy market.

• What cell therapy services does AGC Biologics offer?

  We offer services from process development through commercial manufacturing for both autologous and allogeneic cell therapies, and can support both in-vivo and ex-vivo therapy types. Our expertise covers a wide range of cell types, including CAR-T, hematopoietic stem cells (HSC), mesenchymal stem cells (MSC), induced pluripotent stem cells (iPSC) and more, all supported by our global network of flexible cGMP suites.  

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

  For cell & gene therapies, single-use technologies allow for closed and automated processing, which significantly minimizes contamination risks. Additionally, our single-use viral vector capabilities offer flexible scalability (ranging from 50 L to 2,000 L), supporting rapid platform processes like BravoAAV™ and ProntoLVV™ to accelerate development timelines.

• How does AGC Biologics accelerate timelines for drug development?

  We utilize established platform processes, such as our BravoAAV™ and ProntoLVV™ platforms for viral vectors. These pre-optimized platforms allow partners to move rapidly from gene sequence to cGMP manufacturing without sacrificing quality or safety.  The proprietary process and capsid-specific platform methods can accelerate development timelines, delivering GMP product in nine months.

• Does AGC Biologics offer fill and finish services for cell & gene therapies?

  Yes, we provide comprehensive fill and finish services tailored to your specific modality. 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.  

• Can you support feasibility studies for cell & gene therapies?

  Yes, we offer the CMC Jumpstart™ program, a rapid feasibility study package designed to assess the manufacturability of your cell or gene therapy candidate early in development. This program helps de-risk the path to GMP manufacturing. By offering a firsthand demonstration of AGC Biologics’ expertise, companies can assess how well we can meet their specific project requirements before committing to larger-scale work. Once the GOI is provided, AGC Biologics performs a representative scale-down run that provides essential Chemistry, Manufacturing, and Controls (CMC) data for a company’s top candidate. 

• What is your experience in cell & gene therapy manufacturing?

  AGC Biologics has over 30 years of experience in cell and gene therapy. We have an impressive track record of commercial approvals for both viral vectors and cell therapies, making us one of the most accomplished CGT CDMOs in the industry. Additionally, we have manufactured hundreds of GMP batches for partners around the globe.