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European Biopharmaceutical Review

Therapy at Work

EBR: What is cell therapy?

Dr Daniel Shelly: The use of living human cells as therapeutic treatments can replace lost functionality or introduce a novel function (eg chimeric antigen receptor T-cells to attack tumours). Cell therapies are often classified as either autologous or allogeneic. Autologous cells are obtained from, transformed, and given back to the individual patient, whereas allogeneic cells are sourced from a single donor, grown in large numbers, transformed, and given to multiple patients.

Numerous methods of transformation exist such as using peptides to activate immune cells, using viral vectors to introduce new genetic functions, or gene editing (CRISPR-Cas9) to enhance cellular function. The cell therapy industry is currently at a turning point, driven by significant advances on many fronts, such as a significant amount of product approvals with several more to come, a regulatory recognition of the unique nature of the sector, a financial maturity and investor interest, and finally a general public awareness and interest.

Despite these advances, the sector still needs to optimise several key areas such as manufacture, storage (cryopreservation), formulation, and distribution of such products.

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Dr Daniel Shelly is Director of business development at Albumedix, responsible for business development and out-licensing of the companyís core technologies and recombinant albumin products for manufacture, stabilisation, and formulation of small molecule, peptide, protein, viral, and cell therapeutics. He spent 10 years in cell culture, vaccine, and gene therapy clinical development and manufacturing. Daniel has authored several peerreviewed articles and book chapters and is an Adjunct Professor in the University of Cincinnati, US, clinical masterís programme, teaching biologics discovery and biotechnology management. He has degrees from Lehigh University (BA), US, The College of William and Mary (MA), US, Florida State (PhD), US, and the University of Cincinnati (MBA), US. Daniel did his post doctorate at the University of California, US, winning the APS Physiological Genomics Fellowship and a National Institutes of Health National Research Service Award.
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