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
Email: mailto:dbarry@healthtech.com
For sponsorship information, please contact:
Companies A-K
Phillip Zakim-Yacouby
Senior Business Development Manager
Cambridge Healthtech Institute
Phone: (1+) 781-247-1815
Email: pzakim-yacouby@cambridgeinnovationinstitute.com
Companies L-Z
Aimee Croke
Business Development Manager
Cambridge Healthtech Institute
Phone: (1+) 781-292-0777
Email: acroke@cambridgeinnovationinstitute.com