Cell and Gene Therapy CMC Analytics and Manufacturing

CHI’s Cell and Gene Therapy CMC Analytics and Manufacturing conference is industry’s leading technical meeting for overcoming the latest challenges in CAR T, AAV and viral vector analytics, process development and commercial manufacturing, with two 5-day tracks dedicated to Cell Therapy CMC and Manufacturing AND Gene Therapy CMC and Manufacturing. Key themes across both meetings include product and process characterization, cost-effective scale up, vector quality, regulatory expectations and technical development strategies.

Cell Therapy Detailed Agendas:

Gene Therapy Detailed Agendas:

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Conference at a Glance: Cell Therapy CMC & Analytics, Cell Therapy Manufacturing, Gene Therapy CMC & Analytics, Gene Therapy Manufacturing, Intro to Gene Therapy and Viral Vectors, Design of Experiments for Cell and Gene Therapies

Keynote Presenters Include:

 

Krishnendu Roy, PhD

The Robert A. Milton Chair and Professor, Biomedical Engineering; Director, Marcus Center for Cell Therapy Characterization Manufacturing (MC3M), Georgia Tech

Wen Bo Wang, PhD

Senior Vice President, Technical Operations, Fate Therapeutics

Mo Heidaran, PhD

Vice President, Technical, PAREXEL Consulting, PAREXEL International

Luis Maranga, PhD

Chief Technical Operations Officer, Voyager Therapeutics, Inc.


Sessions Include:


Cell Therapy Stream Sessions:

  • Regulatory Challenges and Emerging CMC Strategies
  • Improving Method Validation and Transfer
  • Assay Development and Product Characterization
  • Emerging Technologies and Development Strategies
  • Commercializing CAR Ts – Allogeneic and Autologous
  • CAR T Manufacturing for Clinical Supply
  • Next-Gen Products and Processes – CART 2.0, TILS
  • Optimizing Scale-up and Manufacturing
  • Next-Generation Manufacturing – Logistics and Supply Chain

Gene Therapy Stream Sessions:

  • Regulatory Expectations and CMC Strategies
  • Analytical Control Strategies
  • Analytical Strategies for Viral Vectors
  • Product Characterization
  • Advancing Analytical Methods
  • Future of Gene Therapy Manufacturing
  • Optimizing Process Development
  • Emerging Manufacturing Strategies
  • Optimizing DSP Strategies

Testimonials


“The conference offered an excellent array of speakers, perfectly captured the current thoughts and movements in the cell therapy manufacturing industry, and had the benefit of giving a tremendously relevant group of institutes for networking and collaborative opportunities.”

Laura Pierce, M.S. Biomedical Engineer, Biosystems and Biomaterials Division, Biomaterials Group, National Institute of Standards and Technology


“The meeting was once again a hit and is a must attend meeting for those in the cell/gene therapy manufacturing space!”

Devyn Smith, PhD, Chief Strategy Officer, Strategy & Ops, Sigilon


“One of the most interactive processing-based meetings I’ve participated in. I was pleasantly surprised by the number of questions after each speaker and the discussion that ensued”

Patrick J. Hanley, PhD, Laboratory Facility Director, Cellular Therapy and Stem Cell Processing, Program for Cell Enhancement and Technologies for Immunotherapy, Division of Blood and Marrow Transplantation, Children’s National Health System


“Great opportunity to participate in round table discussions and engage with experts one-on-one.”

Bernadette K, Principal, Keane Consuling LLC


“A very well planned and coordinated event with a balanced range of speakers from industry and academia. I will look forward to attend this meeting again next year.”

Dr Damian Marshall, PhD., Director, New Technologies, Cell Therapy Catapult


“The meeting was definitely money well-spent. There was sharing of technical and regulatory challenges and people shared their perspectives on solving their problems.”

William Lee, PhD., RAC, Vice President, Regulatory, Cato Research

Recommended Short Courses*

SC3: Quality Considerations for Gene Therapy Viral Vectors
SC10: Phase-Appropriate Analytical and Process Control Strategies

*Separate registration required

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