Day One - Wednesday, November 13
8:00 am Check-In & Light Breakfast
8:50 am Chair’s Opening Remarks
Enabling Alignment & Streamlining Material Control Strategies Through Understanding Regulatory Definitions & Classifications of Raw & Starting Materials for Cell & Gene Therapies
9:00 am FDA Recognized Standards for Raw Materials in Regenerative Medicine Therapies
Synopsis
- The FDA standards recognition program for regenerative medicine therapies
- Current standards under development for raw materials
- Resources for implementing standards for raw materials
9:30 am Defining Raw & Starting Materials for Cell & Gene Therapies to Ensure Alignment in the Field Between Regulators, Cell & Gene Drug Developers & Material Suppliers
Synopsis
- Problem statement and why need material classification
- Material classifications definitions
- Examples of applying material classification and subsequent controls for a material from each category
10:00 am Morning Break & Speed Networking
Synopsis
Our speed networking session is the ideal opportunity to get face-to-face time with your cell and gene therapy raw materials community. Introduce yourself to the attendees that you would like to have more in-depth conversations with, benchmark against industry leaders, and establish meaningful business relationships that you can pursue for the rest of the conference and beyond.
Achieving Higher Safety & Quality of Raw Materials Through Reliable Manufacturing & Testing Strategies to Ensure Production of High-Quality Cell & Gene Therapies
11:00 am Challenges with the Selection of Raw Materials for Cell & Gene Therapies
Synopsis
- Best practices for material evaluation and selection
- Material quality considerations for cell and gene therapies
- Assurance of material supply continuity
11:30 am Scalable & Flexible Solutions for Rapid Raw Material Identification
Synopsis
- Raw Material Identification (RMID) is critical in maintaining and improving quality, consistency and compliance of manufacturing processes. Conventional technologies often require time-consuming sampling and analysis procedures to move raw materials from receipt to production
- Agilent hosts a broad range of robust solutions to safely and efficiently perform RMID for materials relevant to the cell and gene space
- Agilent’s Vaya handheld Raman analyzer, which uses unique technology to ID raw materials through a variety of opaque containers without opening the container at all, enables the fastest and most cost-effective RMID process, eliminates risks associated with sampling, and preserves the integrity of raw materials
11:40 am Raw Materials Considerations for Cell Therapy Product Manufacturing
Synopsis
- Critical needs and challenges for cell therapy raw materials
- Phase-appropriate raw material selection and risk assessment
- Showcasing characterization strategies for critical raw materials
12:10 pm Lunch Break & Networking
Unlocking Release & Stability Testing Strategies for Master Cell Banks (MCBs) & Working Cell Banks (WCBs) to Prove Efficiency & Biological Effect of Your Raw Materials
1:30 pm Key Considerations for Establishing a Working Cell Bank (WCB) as a Biological Raw Material for Release Testing & the Implementation into the Quality Target Product Profile (QTPP)
Synopsis
- Developmental and functional testing strategies needed to determine the proper cellular target to use based on clinical data and clinical considerations. Product characterization testing for biological AMs
- Key regulatory considerations and USPs needed in establishing biological raw material release testing and the stability testing needed to prove efficiency and biological effect over a certain period of time
- What is a QTPP and how should one be structured?
- How and where the process of getting a Master Cell Bank (MCB) and WCB should begin based on the established QTPP?
2:00 pm Roundtable Discussion: An Industry-Wide Opportunity to Benchmark & Knowledge Share on Critical Quality Testing & Regulatory Considerations Associated with Establishing Master Cell Banks (MCBs) & Working Cell Banks (WCBs) to Ultimately Improve Efficiency &
Synopsis
- What kinds of challenges (analytical, regulatory, etc.) are typically faced when looking to qualify a certain type of cell line?
- What considerations are deemed important when establishing MCB or WCB? What was the end goal of this cell bank?
- What kind of release testing should be performed to release the cell bank for use and why did?
- What kind of stability programs should be implemented for the MCB? What kind of analytical testing should be carried out?
3:00 pm Afternoon Networking Break & Scientific Poster Session
Evaluating the Latest Innovations in Analytical Characterization & Stability Testing of Raw Materials for Cell & Gene Therapies Manufacturing in Line with Regulatory Expectations
4:00 pm Analytical Testing & Methods for Raw Materials
Synopsis
- Required analytical tests
- What regulations to follow
- How to select or develop appropriate methods
4:30 pm Raw Materials: Their Stability & the Impact to Your Product
Synopsis
- Current regulation requirements
- Impact to your final drug product
- Improvements to the process and future of cell and gene stability