Adeno-associated viruses (AAV) are among the most common vectors used for ex-vivo and in-vivo gene therapies. Yet, despite hundreds of biotechnology and engineering studies, standard procedures for large-scale manufacturing of these vectors remains inconsistent.

AGC Biologics will discuss AAV-based gene therapy production, managing adherent and suspension processes, and new cost-effective and streamlined approaches for creating large-scale AAV production that can meet any product specification. This plug-and-play concept is built around using transient transfection with PEIpro, and an efficient and scalable off-the-shelf AAV vector production process that will get you to the manufacturing and clinical supply stage as quickly as possible, while reducing complex PD efforts.

Participants: Margherita Neri, Head of Vector Development, AGC Biologics,Claire Wartel, Director of Quality and Compliance, Polyplus-transfection .

Polyplus will share their commitment to viral vector manufacturers in manufacturing therapeutic AAVs with patient safety in mind. Scalable manufacturing of AAV, and viral vector in general, brings up two main challenges that need to be addressed to ensure compliance with cGMP regulations: sourcing of raw materials and management of the supply chain.

  • Concepts for building a plug-and-play system for easier Largescale AAV Production and Manufacturing
  • Solutions for addressing challenges with AAV adherent and suspension cell lines
  • How to create cells lines and media scouting
  • The importance of scale down models for process development
  • How to ensure compliance with cGMP regulations for raw and starting materials used in AAV manufacturing

Source: AGC Biologics.