Ensuring Quality of Product Throughout Gene Therapy Production, Manufacture and Scale-Up

Wednesday, January 17, 2024 at 1:00 PM to 2:00 PM · 1 hr. (US/Eastern)
Gene Therapy Manufacturing
Presentation
Theatre 2

Information

Chair

Nathalie Clement, Vice President, Vector Development, Translational Gene Therapies, Siren Biotechnology

1pm Presentation Title: Building and Maintaining Quality in a New Gene Therapy Manufacturing Facility

Sarah Thomas, Senior Vice President, Quality, REGENXBIO


1.15pm Presentation Title: Navigating Complexities of Viral Vector Production for Gene Therapies

  • Learn about standardizing LVV and AAV production to streamline the path to GMP
  • Explore comprehensive analytical panels that can accelerate your clinical journey

Francesca Bellintani, MSAT Director, AGC Biologics


1.30pm Presentation

Alex Bloom, Chief Technology Officer, AviadoBio


1.45pm Presentation Title: Exploring the Future of Scalable Gene Therapies

  • Exploration of the next several years of gene therapy development, looking at the evolution of the gene therapy manufacturing platform.
  • Evaluation of who of the industry is pursuing stable producer cell lines, how are they pursuing, and what are the biggest hurdles.
  • A look at how CMOs can play a critical role in this industry evolution, with commentary on the potential risks and rewards for engaging with these organizations.

Peter Walters, Fellow, Advanced Therapies, CRB Group

Modality
Gene Therapy
AGC Biologics318AGC Biologics is a global CDMO providing pharmaceutical process development and manufacturing services for protein-based biologics and cell and gene therapies. With seven facilities and teams of scientists across three continents, we have the resources and the available capacity you need to accelerate your race to GMP. From development to clinical trials to full-scale commercialization, we can help you reach your goals at any stage in the drug development and manufacturing process. We specialize in the following modalities and substances: mammalian and microbial-based therapeutic proteins, recombinant DNA, plasmid DNA, viral vectors, Messenger RNA (mRNA), and genetically engineered cells. Our services range from Process Development, Analytical Development, cGMP Manufacturing (both clinical and commercial), Quality Control, and Quality Assurance and Process Validation.

Documents & Links

  • Sarah Thomas, REGENXBIO

    Building and Maintaining Quality in a New Gene Therapy Manufacturing Facility

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