Cambridge Healthtech Institute’s 5th Annual

Gene Therapy Manufacturing

Improving Production, Purification, and Yield

20-21 March 2024


Cambridge Healthtech Institute’s Gene Therapy Manufacturing conference tackles the practical challenges facing the production, scale-up, and purification of viral and non-vector-based gene therapies. Topics include cell line development, upstream processing, recovery and purification, preparing for commercial manufacturing, and scale-up for clinical and commercial supply. Examples will come from the world of AAV and lentiviral vectors, mRNA, and other non-viral approaches.


Coverage will include, but is not limited to:


Gene Therapy Process Development—Cell Line to Cell Culture

  • Process design and development strategy—media development, clone selection, cell line development, increasing yield, robustness, speed of scalability, stability
  • Producer cell lines; new vector, emerging cell lines
  • Process intensification strategies—dealing with increased cell mass, yields
  • Scaling up—moving from adherent to suspension, challenges; challenges scaling transient-based processes and industry examples
  • Transfection agents, engineering vectors, metabolic engineering


Downstream Processing and Formulation

  • Downstream development—innovations in capture, depth filtration, resin selection, chromatography, scalability
  • Handling increased mass—harvest, clarification strategies
  • Particles—mixed mode, cation exchange.
  • What level of full/empty is required?
  • Process consideration
  • Viral safety considerations using viral vectors


Commercial-Scale Gene Therapy Manufacturing

  • Preparing for commercial manufacture: scale-up strategies, COGs; is triple transfection the most suitable manufacturing platform? For/against
  • Manufacturing networks, sharing facilities vs. internal vs. outsourcing models
  • Developing commercial-ready platforms
  • Scalability—Phase I to Phase III to commercial
  • Does adding internal manufacturing capabilities add value?


Role of AI and Digitalization in Gene Therapy Production

  • Bioprocessing 4.0, and AI in gene therapy manufacturing
  • Machine learning in optimising gene therapy production


Process Development for Non-Viral Gene Therapies, mRNA, and Exosomes

  • Process development for mRNA therapies—what are the bottlenecks?
  • Non-viral gene therapies—what are the unique considerations?
  • Case studies to demonstrate quality and purity


Formulation, Fill, and Finish

  • Successful formulation strategies
  • Advances in formulation, stability
  • Pre-formulation strategies for gene therapies, forced degradation
  • Particle analysis, impact on stability, lyophilization
  • How are we administering to patients?
  • Improvements in delivery, buffer choice, thaw, freeze, logistics
  • Fill and finish—working with CMOs, scaling up from the lab, issues
  • Supply chain issues—outsource vs. internal formulation


The deadline for priority consideration is Friday 22 September.


All proposals are subject to review by session chairpersons and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute policy, a select number of vendors and consultants who provide products and services will be offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.


Opportunities for Participation:



For more details on the conference, please contact:

Daniel Barry

Senior Conference Director

Cambridge Healthtech Institute

Phone: (+44) 7837 651 303



For sponsorship information, please contact:


Companies A-K

Phillip Zakim-Yacouby

Senior Business Development Manager

Cambridge Healthtech Institute

Phone: (1+) 781-247-1815



Companies L-Z

Aimee Croke

Business Development Manager

Cambridge Healthtech Institute

Phone: (1+) 781-292-0777