Cambridge Healthtech Institute ’s 2nd Annual

Gene Therapy CMC and Manufacturing

Ensuring the Supply and Quality of Viral Vectors

25-26 March 2020

 

Robust and cost-effective viral vector characterization and manufacturing presents a core challenge in the commercialization of gene therapies with pressure mounting on CMC, analytical and manufacturing teams to keep up with accelerated development times and cost pressures.

CHI's Gene Therapy CMC and Manufacturing conference examines the critical challenges facing the production, characterization and quality control of vector-based gene therapies, with dedicated sessions on rapid CMC development, product and process characterization, upstream and downstream bioprocessing and considerations for large-scale manufacturing.

Preliminary Agenda

CMC AND ANALYTICS

KEYNOTE PRESENTATION: Rapid CMC Development and Pre-Commercial Considerations for rAAV Gene Therapy Products for Rare Diseases

James Warren, PhD, Vice President, Pharmaceutical Development, Ultragenyx

Phase-Appropriate Potency Assay Development for Gene Therapy Products

Francis Poulin, PhD, Director, Analytical Development, Sanofi

Relative vs. Absolute Quantification of Purified and In-Process rAAV Productions

Kamila Pytel, PhD, Team Leader, CMC Analytical Development, Gyroscope Therapeutics

Talk Title to be Announced

Alan Griffiths, PhD, Viral Vector Development, MeriaGTX

Analytical Challenges for Gene Therapy

Clare Blue, PhD, Director, Analytical Development, Biogen

Developing Faster Analytics, DLS for Aggregation, Stability Indicating Assays, Adoption of Digital Droplet PCR

Christine Le Bec, PhD, Head of CMC Analytical, Technology Development, Genethon

Analytical Development and Product Characterization Strategies

Robert Pletzenauer, Head, Process Analytics, Takeda Gene Therapy Process Development

Controlling Cell and Gene Therapy Manufacture through PAT

Damian Marshall, PhD, Head, Analytical Development, The Cell and Gene Therapy Catapult

PROCESS DEVELOPMENT AND MANUFACTURING

AAV Manufacturing: Early Development to Long-Term Manufacturing Strategies

Jean-Philippe Combal, PhD, Co-Founder and CEO, Vivet Therapeutics

Increasing Throughput and Decreasing Speed for Phase I Process Establishment

Terrence Dobrowsky, PhD, Principal Engineer, Gene Therapy, Biogen

Upstream Process Development Strategies for Gene Therapies

Eduard Ayuso, DVM, PhD, Team Leader, Innovative Vectorology; Scientific Director Translational Vector Core (CPV), Translational Gene Therapy for Genetic Disorders, Inserm, University of Nantes

Challenges in Process Scale Up with 500 L Scale Manufacturing of AAV

Marian Bendik, PhD, Site Lead Orth, Gene Therapy Center Austria, Biologics Operating Unit, Technical Operations, Takeda

Development of a Robust Purification Process for Adeno-Associated Virus

Matthew Roach, PhD, Process Development Engineer, Precision Biosciences

Generation of Packaging Cells for Lentiviral Vectors Using Nanowell-Based Single Cell Cloning Technology

Rénald Gilbert, PhD, Team Lead, Viral Vector Production, NRC Montreal

Upstream Process Development Strategies for Gene Therapies

Ana Sofia Coroadinha, PhD, Lab Head, Health & Pharma Division, Animal Cell Technology Unit Cell Line Development and Molecular Biotechnology Lab, IBET




For more details on the conference, please contact:
Daniel Barry

Senior Conference Director

Cambridge Healthtech Institute

Phone: 781-247-6266

Email: dbarry@healthtech.com

 

For partnering and sponsorship information, please contact:

Companies A-K

Sherry Johnson

Senior Business Development Manager

Cambridge Healthtech Institute

Phone: 781-972-1359

Email: sjohnson@healthtech.com

 

Companies L-Z

Carolyn Cooke

Business Development Manager

Cambridge Healthtech Institute

Phone: 781-972-5412

Email: ccooke@healthtech.com