Conference Day One: Wednesday, June 12, 2024
7:30 am Check-In & Coffee
8:30 am Chair’s Opening Remarks
Uncovering Key Challenges, Areas of Innovation & Promises for the Future
8:40 am Industry Leaders’ Fireside Chat: Insights from Industry Leaders on Overcoming Current & Future Challenges in Cell Therapy Process Development
Synopsis
- What are the key challenges currently hindering effective process development?
- What challenges can we expect to arise in the next 5 years?
- How can vendors help biopharma to pave the way forward?
9:30 am T Cell Expansion Using Chemically Defined Media & Recombinant Proteins in Dynamic Cultivation Conditions
Synopsis
- Exploring key considerations when selecting raw materials for cell culture media development
- Reviewing T cell expansion in static and dynamic culture conditions
- Outlining DMSO-free and chemically defined cryopreservation solutions for short- to long-term cell preservation
10:00 am Morning Break & Speed Networking
Synopsis
As this community re-unites for the third time, this session will provide valuable networking time with your peers, enabling you to forge new and lasting connections.
Implementing a Systematic Approach to Process Strategy for Optimal Outcomes
11:00 am Developing a Process in Line with Quality by Design Principles
Synopsis
- Exploring Quality by Design (QbD): a step-by-step approach that investigates which factors may affect the quality of the final product
- Putting QbD terminology to use: quality target product profile, critical process parameter, design of experiments, control strategy, process analytical technology etc.
- Implementing an effective control strategy early on in development to ensure a robust process
11:30 am Finding the Balance: Developing a Phase Appropriate Manufacturing Process with Learnings from R&D
Synopsis
- Applying a phase appropriate method to process development: understanding “what” is needed and “when” it is needed for each phase of the drug development process
- How do you transition effectively between research and process development groups?
- How do you overcome challenges with lack of GMP grade materials?
12:00 pm Development & Tech Transfer of a Platform Process Utilizing a Functionally Closed System
Synopsis
- Selection of a manufacturing system early in pre-clinical development allows for collaboration between Research and Process and Analytical Development teams
- Building a process using the same equipment and analytics allows for a smoother and more efficient tech transfer to a manufacturing site
- Properly managing the tech transfer with a CDMO partner is key to a successful start of clinical manufacturing
12:30 pm Lunch Break & Networking
Optimizing Starting Material Quality to Guarantee a Consistent & Robust Downstream Process
1:30 pm Starting Material for Autologous Cell Therapies: Beginning with the End in Mind
Synopsis
- Ensuring patient centric process development: moving from healthy donors to patient material
- Exploring monocyte depletion and/or T cell enrichment to manage the heterogeneity of the starting material
- Selecting a cell population that ensures downstream process robustness
2:00 pm Bridging the Translational Gap
Synopsis
- Highlights of our Direct-to-Donor model which provides comprehensive and relevant health data across a large network, spanning 100+ indications
- Overview of how Sanguine's biospecimen products and services for pre-clinical research, assay and process validation drive stronger results
- Examples of success with our partners in the cell therapy development space
2:10 pm Starting Material Considerations for iPSC-Derived Cell Products
Synopsis
- Utilizing a risk-based approach to address starting materials, donor eligibility, cell banking and genetic stability
- Implementing phase-appropriate cell collection processes to obtain consistent, compliant, and high-quality starting materials
- Interpreting FDA cGMP guidance for Phase 1 investigational drugs
2:40 pm Panel Discussion: Recognizing the Importance of Quality Starting Material for the Downstream Process
Synopsis
- How do we reconcile the jump from healthy donor to clinical patient material?
- How selective should we be with the starting cell populations?
- How does cellular starting material variability impact downstream product quality?
3:15 pm Afternoon Break & Networking
Overcoming Downstream Processing Challenges to Maximize Cell Product Safety & Efficacy
4:00 pm Investigating Methods for Visual Inspection to Maximize Patient Safety
Synopsis
- Characterizing the particulates generated in the manufacturing process
- Understanding how these particles impact the safety and efficacy of the cell therapy product
- Exploring the current methods available for particulate detection and their effectiveness: visual inspection, light microscopy, flow cytometry, dynamic light scattering
4:30 pm Exploring Best Practices for Cryopreservation of the Final Drug Product to Maintain Viability & Efficacy
Synopsis
- Understanding and mitigating the effects of DMSO on cell viability
- Deciding on an optimal freezing profile to maximize yield
- Controlling cell viability across the thawing process following cryopreservation to maintain product efficacy
5:00 pm Panel Discussion: Navigating Challenges and Innovations in Cryopreservation for Cell Therapies to Improve Cell Viability & Function
Synopsis
- What are the greatest challenges currently faced in cryopreservation?
- What are the areas with potential for growth and optimization?
- How are technologies for cryopreservation expected to evolve in the near and distant future?