Conference Day Two: Thursday, June 13, 2024
8:00 am Check-In & Coffee
8:50 am Chair’s Opening Remarks
Implementing Cutting-Edge Technology & Methods to Revolutionize Process Design
9:00 am Automation & Digital Manufacturing of Cell Therapy Products – Why Paper is the Enemy of Scale
Synopsis
- Implementing an automated and digital workflow to improve regulatory compliance and save costs
- Understanding the importance of technology as it relates to automation and standardization within cell therapy manufacturing
- Leveraging digital tools to expedite root cause analysis and process optimization
9:30 am Select & Expand Your Desired Phenotype While Reducing Risk & Increasing Speed to Patient
Synopsis
- Reducing time and improving biological precision during process automation
- Maintaining early and central memory T cell markers for improved therapeutic efficacy
- Improving process consistency and scalability with high cell viability and improved growth
10:00 am Morning Break & Networking
Collaborating Seamlessly with Different Internal & External Teams to Expedite Timelines
11:00 am Accelerating Early-Phase Development: A Collaborative Approach Between Research and Process Development
Synopsis
- Ensuring synergy between research and process development teams by addressing common challenges
- Co-developing early phase functional assays to enable impactful discovery
- Utilizing emerging technologies to expedite early-phase development
11:30 am Developing an Effective & Streamlined Process with an External CDMO
Synopsis
- Exploring key considerations for CDMO selection – do they have both the vision and the experience to carry out the plan?
- Assess potential process parameter changes during the transfer and evaluating the impact and risks of such changes
- Ensuring both teams have a strong expertise in process development, both scientifically and operationally, to ensure a smooth tech transfer
12:00 pm Lunch Break & Networking
Enhancing Process Scalability to Facilitate Manufacture at Clinical & Commercial Scale
1:00 pm Preparing for Pivotal Product Manufacturing: Scale-up Considerations for Large-Market Allogeneic Cell Therapies
Synopsis
- Addressing significant unmet need in cancer and autoimmune disease indications with Atara’s robust pipeline of investigational allogeneic CAR-T immunotherapies
- Preparing for pivotal product manufacturing from the perspective of a commercialized cell therapy company
- Moving from static to suspension cell culture production to enable scalability of T-cell therapy manufacturing and favorable cost-of-goods
1:30 pm Allogeneic Cell Therapy Scale-Up Strategies for Commercial Success
Synopsis
- Scaling allogeneic process from clinical to commercial
- Addressing challenges and presenting potential solutions to alleviate the anticipated bottlenecks of scale-up
- Potential challenges of harvest, fill finish, other logistics
2:00 pm Panel Discussion: Accelerating Process Scale-Up for Allogeneic Cell Therapies
Synopsis
- What are the biggest challenges regarding process scale-up?
- What are the potential solutions to alleviate the anticipated bottlenecks for commercial-scale manufacture of high-quality therapeutic cells?
- How can service providers aid with process scale-up?
2:30 pm Afternoon Break & Networking
Overcoming Key Process Challenges to Unlock the Full Potential of Gene Edited Products
3:00 pm CRISPR/Cas9-Based Engineering of a Large & Modular Cassette into a Safe Harbor Site to Improve CAR-T Cell Therapy Efficacy & Safety
Synopsis
- Discussing advantages of ArsenalBio’s targeted, non-viral engineering platform, CRISPR integration of transgene by electroporation (CITE)
- Identifying and characterizing on- and potential off-target integration sites
- Developing a robust and scalable electroporation-based manufacturing process for integrated circuit T (ICT) cells
3:30 pm Developing a Closed, Automated CRISPR-Cas9 Editing Process for a TIL Product
Synopsis
- Developing a system where the genetic modifications are carried out within a sealed environment
- Incorporating a “flow electroporation Process Assembly (PA)” to precisely deliver CRISPR components to TILs, maintaining sterility throughout the editing process, and minimizing contamination rises
- Enhancing reproducibility, ensuring the safety and efficacy of the editing TIL product