Analytical Development

PCT’s analytical development team works with clients to create testing methods that satisfy the Chemistry Manufacturing and Controls (CMC) requirements of an IND or BLA filing with the FDA. PCT develops analytical methods used for testing cell therapy products for identity, purity, potency and sterility, and also for certain additional measures of safety, as required by the FDA. PCT also performs assay validation services.

Examples of analytical methods PCT can help clients develop include:

Identity

Cell surface phenotype associated with the therapeutic cell of interest (e.g., expression of the chimeric antigen receptor for CAR T cells, expression of CD4 and FoxP3 by regulatory T cells, expression of transgene in gene therapy approaches -- flow cytometry is typically used for such measurements).

Purity

Examples would include cell surface marker expression associated with unwanted/contaminating cells (typically by flow cytometry)

Potency

Examples might include suppression of T cell proliferation by regulatory T cells, cytotoxicity assay for antigen-specific T cells, ability to form capillary-like structures for endothelial progenitor cells.

Also, for product release, surrogate markers associated with biologic activity may also be used (e.g., IL-12 secretion by dendritic cells).

Sterility

Compendial tests are typically used, but quick surrogate assays are sometimes developed for products that need to be infused fresh (an example would include Mycoplasma PCR)

Other measures of safety

For example, cellular proliferation assay to determine that tumor cell component used in some cancer therapies has been inactivated.

David O'Neill, MD,Director, Analytical Development Medical Director,
MD Ohio State University

David is licensed to practice medicine in CA, NJ and NY, and is board-certified in anatomic pathology, clinical pathology and blood banking/transfusion medicine. He has over 20 years of academic and 5 years of industry research experience in hematology, immunology and stem cell biology, including the molecular biology and biochemistry of globin gene regulation, GMP production of cellular immunotherapies, vaccine design and immune monitoring for clinical immunotherapy trials for cancer, autoimmune disease and HIV infection.

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Together, PCT’s process and analytical development services, combined with our Center for Innovation & Engineering, ensure that our cell therapy clients will have a manufacturing process that is optimized to deliver products in a reasonable timeframe, in a scalable, sustainable way that meets all applicable regulatory requirements.

In addition to analytical development, we also offer process development services.