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European Biopharmaceutical Review

Autologous, Allogeneic CAR T, and the New Frontiers of CAR NK Immunotherapy Products

T cell immunotherapy is a treatment that boosts the adaptive immune response when exposed to tumour antigens to fight cancer. The observation of a response against cancer after the infusion of ex vivo-expanded specialised autologous T cells, tumour-infiltrating lymphocytes, showed the potential of these cells for cancer immunotherapies. The ex vivo cultivation allows in vivo persistence of these tumour-specific cells that already exist in small numbers but are suppressed by the local microenvironment.

Functionally similar to cytotoxic T cells, natural killer (NK) cells kill the target through similar cytotoxic mechanisms but without any prior activation through the T cell receptor (TCR). NK cells can trigger a potent anti-tumour immunity via multiple mechanisms. They act through antibody-dependent cell-mediated cytotoxicity (ADCC) in which antibodies, bound to the target cells, activate NK cells through the receptor of the fragment crystallisable (Fc) portion of the immunoglobulins. Clinical studies have already demonstrated the potentiality of these cells for the treatment of haematological and solid cancers.

CAR T Products

Gene transfer technology has been used to transfer synthetic chimeric antigen receptors (CARs) to T cells, enhancing their potential use in immunotherapy. The extracellular CAR construct consists of a target-binding domain, part of synthetic antibodies, enabling the T cell to recognise any specific cell surface molecule. Engagement of the CAR by its ligand transmits a signal to the intracellular T cell machinery. Co-stimulatory molecules enhance T cell proliferation and persistence.

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Claudia Benati is Senior Scientific Director at Eurofins BioPharma Product Testing, Italy, and qualified person for advanced therapy medicinal products (ATMPs). She studied Biological Sciences and specialised in Medical Genetics. Claudia is experienced in cell and gene therapies development and manufacturing for clinical trials, with a specific focus in orphan drugs and CAR T cell products. In Eurofins, she supports analytical methods development and company strategies for biologics and ATMPs.

Giulia Mancini, PhD is the Project Leader of the bioassay area in Eurofins BioPharma Product Testing in Milan, Italy. She lends her R&D experience to support the development, implementation, and validation of cell based bioassay and immunoassays testing. Giulia holds a Mastersin Medical Biotechnology and Molecular Medicine from the University of Milan, and a PhD in Biochemical Science.

Stanley Prince, Senior Scientific Advisor, Biologics, for Eurofins BioPharma Product Testing has more than 17 years of development experience in the CRO and biotechnology space. Stanley provides technical and commercial support for GMP biosafety services for large molecule and cell and gene therapy projects, helping clients to navigate specialised testing needs. He earned a BSc degree in Life Sciences from Penn State University and an MBA from Alvernia University, US.

Marian L McKee, PhD is Vice President of BioSafety Testing at Eurofins Biopharma Product Testing in Lancaster, US. She lends her industry experience to support traditional biosafety testing. In addition, she focuses on the development and strategic insight into the company’s gene and cell therapy offering. Marian holds a BSc in Zoology from Duke University, US and a PhD in Microbiology and Immunology from Uniformed Services University of the Health Sciences. She was a CRTA Postdoctoral Fellow at the National Cancer Institute, NIH.

Frederic Girard, PhD, is Managing Director at Eurofins Spinnovation Analytical in Oss, The Netherlands, and Senior Scientific Director at Eurofins Biopharma Product Testing, covering the scope of NMR Spectroscopy and Solid-State Characterisation. A chemist by training, Frederic obtained a PhD in Biophysical Chemistry in 2000 from the University of Orleans, France. After a Postdoctorate in Structural Biology (Umeĺ University, Sweden; Radboud University, Netherlands), he founded Spinnovation Analytical in 2005, acquired by Eurofins in 2017.

A chemist by training, Frederic obtained a PhD in Biophysical Chemistry in 2000 from the University of Orleans, France. After a Postdoctorate in Structural Biology (Umeĺ University, Sweden; Radboud University, Netherlands), he founded Spinnovation Analytical in 2005, acquired by Eurofins in 2017.




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