Partnering for Gene Therapy Manufacturing - What is the Key to Success?

Partnering for Gene Therapy Manufacturing - What is the Key to Success?

Thursday, January 18, 2024 10:00 AM to 11:00 AM · 1 hr. (US/Eastern)
Gene Therapy Manufacturing
Presentation
Theatre 2

Information

Chair

Chris Lorenz, Chief Technical Officer, Mahzi Therapeutics

10am Presentation: Partnering for Scalable Suspension Processes Tailored to AAV Gene Therapies

  • Business Challenges in Scaling
  • Seamless Scaling Through Comprehensive Optimization
  • Parameters to Achieve Productivity and Quality

Matt Niloff, Chief Commercial Officer, Andelyn Biosciences



10.15am Presentation: Partnering for Gene Therapy Manufacturing - What is the Key to Success?

Pamela Whalley, CMC Manager, Complement Therapeutics



10.30am Fireside Chat

  • The real differences between a true partnership and a client/service provider relationship.
  • Lessons learned on the path from IND to BLA.
  • Top 3 priorities to make sure get right when you form your partnership.

Angela Chen, Chief Business Officer, WuXi Advanced Therapies



10.45am Closing Q&A

Modality
Gene Therapy
Andelyn BioSciences521Andelyn Biosciences (https://www.andelynbio.com/) is pioneering solutions that turn hope into reality as a cell and gene therapy CDMO. Capabilities span viral vector process and analytical development, small to large scale adherent and suspension based GMP manufacturing up to 2000L. Having 20+ years of experience with viral vector manufacturing, Andelyn offers access to globally recognized thought leaders with troubleshooting/characterization expertise and GMP material produced for 75+ worldwide clinical trials. In addition to producing 400+ cGMP clinical batches, Andelyn provides research and tox grade plasmids with an additional offering of GMP plasmid manufacturing, full quality system/regulatory support and supply chain vertical integration. Its state-of-the-art 185,000 sq ft commercial manufacturing facility will expand capacity across 16+ production suites for customization of new programs and tech transferred programs as of September 2022, offering clinical through commercial-scale capabilities that will help accelerate innovative therapies to bring more treatments to more patients. Gene and cell therapy, AAV viral vector manufacturing, Plasmid Manufacturing, Lentiviral vector Manufacturing, Commercial Manufacturing, CDMO, analytical method development, GMP, fill finish, QC/QA release testing, Process Characterization, Regulatory Affairs, Licensing.

Documents & Links

Matt Niloff, Andelyn BioPartnering for Scalable Suspension Processes Tailored to AAV Gene Therapies

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