CONFERENCE DAY ONE | Wednesday, October 8
8:00 am Check-In & Light Breakfast
9:00 am Chair’s Opening Remarks
Developing Regulatory Compliance for GMP Manufacturing for Raw Materials in Cell & Gene Therapy
9:10 am Regulatory Insights into the Evaluation of Extractables in Biologic Therapies: FDA Perspectives & Case Studies
Synopsis
- Overview of FDA methodologies for identifying and assessing extractable substances in biologic drug packaging and delivery systems
- Common challenges and considerations when interpreting analytical data during regulatory review
- Case examples highlighting FDA’s decision-making process and expectations for supporting data
9:45 am Understanding Which Guidance to Adhere to & Leveraging FDARecognized Standards for Raw Materials in Cell & Gene Therapies
Synopsis
- Discussing the current standards under development for raw materials in cell and gene therapy
- Which resources can be used for implementing new standards for raw materials
- Positioning your organization for future regulatory expectations and standardization trends
10:15 am Morning Break & Speed Networking
Unravelling the Route to Commercialization: Raw Material Strategy Case Studies for BLA Approval
11:15 am Ensuring Safety & Compliance in Extractables & Leachables in Cell & Gene Therapy
Synopsis
- Evaluate materials and components used across our cell and gene therapy workflows for potential E&L risks
- How we designed and implemented a tailored E&L study to fit our specific product format and manufacturing process
- Interpreting results to guide material selection, improve product safety, and support successful development milestones
11:45 am Speaking Position Reserved for Sartorius
12:15 pm Collaborating with Vendors to Transition RUO Materials to GMP Ready Materials for Commercialization of Products
Synopsis
- Understanding the challenges of moving from research grade media to GMP grade for late-stage manufacturing
- Collaborating with suppliers to develop supporting materials and GMP required information
- Aligning supplier capabilities with commercial needs to ensure seamless transition and compliance
12:45 pm Lunch Break & Networking
Developing Robust Raw Material Qualification Programs Insights from Industry Benchmarks
1:45 pm Owning the Risk Managing Raw Material Qualification when Suppliers Fall Short
Synopsis
- Understanding the level of due diligence required when using research-use-only or poorly documented reagents in clinical and commercial manufacturing
- Navigating practical strategies for tracing raw material quality and risk down to secondary and tertiary component levels when suppliers provide limited data
- Developing internal qualification frameworks and risk assessments to ensure regulatory readiness, despite inconsistent or incomplete supplier documentation
2:15 pm Completing the QBD Picture Integrating CPPs, CQAs, & CMAs for Smarter Process Design
Synopsis
- Clarifying the distinct roles of CPPs, CQAs, and CMAs in building a robust QBD framework
- Using risk assessments to identify which raw materials require qualification and why CMAs are key to that process
- Leveraging a complete attribute-based approach to enhance process understanding and reduce variability in manufacturing
2:45 pm ProDeMaCon: Lessons Learned from a Decade in Cell & Gene Therapy Material & Supplier Management
2:55 pm Afternoon Break, Networking & Poster Session
Synopsis
This is an informal session to help you connect with your peers in a relaxed atmosphere to continue forging new and beneficial relationships. With an audience of cell and gene therapy experts eager to explore the latest advancements in raw materials and bioprocessing, you’ll have the opportunity to present a poster showcasing your own work and innovations. This is your chance to connect, share insights, and lead the conversation.
Ensuring Quality & Consistency in Single Use Consumables through Robust Testing Strategies
4:00 pm Validating the Quality of Single-Use Consumables through Material Characterization & Supplier Transparency
Synopsis
- Characterizing single-use consumables through extractables and leachables testing, mechanical integrity checks, and compatibility studies
- Visible particles risk assessment methodology and control in single use consumables
- Developing a risk-tiered qualification framework to prioritize testing depth based on product contact risk, process criticality, and frequency of consumable use
4:30 pm Taming Variability to Ensure Raw Material Consistency in a Complex Supply Landscape
Synopsis
- How to collaborate with suppliers to secure lot specific documentation that is critical for continuity and GMP compliance
- How best to engage suppliers in proactive lot-to-lot variability support, including setting expectations into agreements and fostering transparency for quality requirements
- Examining the challenges of qualifying redundant suppliers to mitigate risk and ensure uninterrupted supply, particularly in light of lot-to-lot variability concerns