Mar
22
2022
On demand

What does Plug-and-Play offer large-scale AAV manufacturing?

Live30 webinars are thirty minute presentations designed to update you on the latest innovations, applications and data in a fast yet interactive format.

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.

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

Margherita Neri

Head of Vector Development, AGC Biologics

Margherita Neri is vector process development manager in MolMed. She joined MolMed in 2012 working in the Quality Control Unit and then in Development Unit. She gained knowledge and experience in the design of vector production processes. She is involved in the process development and industrialization of large scale production of lentiviral and AAV vectors in compliance to GMP requirements. She holds a degree in Pharmaceutical Biotechnology from Università degli Studi - Milano and a Ph.D. in molecular medicine with a study on gene therapy for lysosomal storage disorder

Claire Wartel

Director of Quality and Compliance, Polyplus-transfection

Claire owns a Ph.D. in Molecular Pharmacology and Pharmacochemistry from the University of Strasbourg (France, 1999). After several post-docs in different prestigious universities, Claire joined Polyplus-transfection in 2004 as Cell Biology project leader and participated in the development of our flagship product jetPRIME®. Claire has taken Quality responsibility since 2007, and nowadays manages the department of Quality and Regulatory Affairs.

SPEAKERS

Margherita Neri
Vector process Development Manager at MolMed SpA
Claire Wartel-Weill
Director, Quality & Compliance at Polyplus-transfection

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