Welcome to the 4th Cell Therapy Analytical Development Summit

The number of cell therapies moving through clinical development continues to soar exponentially in the quest to develop a cure for cancer. This explosive excitement fuels the need to develop analytical tools and technology to effectively characterize cell products to prove their safety, quality, potency, and purity.

Join over 160 industry experts across 3 comprehensive days with 6 deep-dive workshops and 2 dedicated tracks to discuss:

1. Regulatory guidance defining the best approach to submit filings (i.e., IND, BLA) with regulatory bodies, overcoming both early- and late-stage hurdles, with expertise shared from Legend Biotech and Innovative Cellular Therapeutics (an EX-FDA employee)

2. Selection of reference standards and controls, outlining published and in-progress documentary standards for cell counting & viability, and producing your own reference standards for release testing, with expertise shared from Adicet Bio and National Institute of Standards & Technology

3. Strategies to develop a successful potency assay matrix to determine product activity, overcoming challenges including starting material variability, limited lot size, lack of appropriate reference standards, complex mechanisms of action and more, with expertise shared from IN8bio and Takeda

4. Process and product related impurities, understanding best practices to reduce or eliminate impurities to acceptable levels for risk mitigation, and reviewing tools to measure and characterize impurities, including mass spec, with expertise shared from Elevate Bio and Sana Biotechnology

5. Analytical and process development changes during clinical-stage manufacturing, exploring the alignment of CQAs with the process control and analytical testing strategy, and exploring features that make an instrument appropriate for in-process PAT, with expertise shared from Novartis and Talaris Therapeutics

“A great way to learn and discuss the common struggles and issues we deal with as scientist pursuing innovation while abiding by the regulatory standards of cell therapy analytical development”
Associate Scientist, BMS