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Welcome to the 6th Cell Therapy Analytical Development Summit. Join us in Boston this December to refine your analytical testing. ... Refine Analytical Testing to Confidently Characterize Cell Potency, Safety & Viability. Skip to content. Ran December 2024. GET UPDATES FOR …

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What is the cell therapy analytical development summit?

The Cell Therapy Analytical Development Summit is the leading industry-defining forum made exclusively for analytical, process development, CMC, QC, and regulatory experts. It explores Assay Development for Best-in-Class Early-Stage Characterization, returning for its 5th year. ...

How do you troubleshoot potency assay development?

Troubleshoot Potency Assay Development, Determine Required Reference Standard Material & Implement Potency Assurance to Meet New Regulatory Requirements for Cell Therapies Establish Mechanism of Action, Quality Control & Regulatory Compliance In the ever-evolving cell therapy landscape, the challenge of potency assay development remains critical. ...

What is potency in cellular therapy?

1 Consulting on Advanced Biologicals, Ltd, London, UK. The evaluation of potency plays a key role in defining the quality of cellular therapy products (CTPs). Potency can be defined as a quantitative measure of relevant biologic function based on the attributes that are linked to relevant biologic properties. ...

What are the challenges faced in developing a cell-based potency test?

Challenges Faced in Developing a Cell-Based Potency Assay: Measurement of potency plays an essential role in quality control, GMP product release, comparability, and stability testing for both drug substances and drug products. ...

Which cells are used in a potency assay?

Cell-line stability and cell identity are both important to preserving assay repeatability over time. Primary cells such as hepatocytes, bone-marrow cells, and endothelial cells are good options for in vitro studies, but they are all difficult to grow and can contribute to assay variability. We use primary bone-marrow cells in our potency assay. ...

How does a cell-based potency assay work?

Such assays can determine the relative potency of a product by comparing its biological response (activity) — related to its MoA — with that of a control/reference preparation usually based on pharmacopeial or in-house standards. Several factors can contribute to cell-based potency assay variability. ...