Selecting a Cell Engineering Methodology During Cell Therapy Product Development

Author:

Timmins Lauren M.1ORCID,Burr Alexandra M.1ORCID,Carroll Kristina12,Keefe Robert3,Teryek Matthew1,Cantolupo Louis J.4,van der Loo Johannes C. M.5,Heathman Thomas R.J.6,Gormley Adam J1,Smith David7ORCID,Parekkadan Biju1

Affiliation:

1. Department of Biomedical Engineering, Rutgers University, Piscataway Township, NJ, USA

2. Precision Biosciences, Durham, NC, USA

3. MaxCyte, Inc, Gaithersburg, MD, USA

4. Consulting, LLC, Butterworth Place NW, Washington, DC, USA

5. The Raymond G. Perelman Center for Cellular and Molecular Therapeutics, The Children’s Hospital of Philadelphia, Philadelphia, PA, USA

6. Ori Biotech North America, INC, Woodcliff Lake, NJ, USA

7. Minaris Regenerative Medicine, LLC, Allendale, NJ, USA

Abstract

When considering the development pathway for a genetically modified cell therapy product, it is critically important that the product is engineered consistent with its intended human use. For scientists looking to develop and commercialize a new technology, the decision to select a genetic modification method depends on several practical considerations. Whichever path is chosen, the developer must understand the key risks and potential mitigations of the cell engineering approach. The developer should also understand the clinical implications: permanent/memory establishment versus transient expression, and clinical manufacturing considerations when dealing with transplantation of genetically engineered cells. This review covers important topics for mapping out a strategy for developers of new cell-based therapeutics. Biological, technological, manufacturing, and clinical considerations are all presented to map out development lanes for the initiation and risk management of new gene-based cell therapeutic products for human use.

Funder

National Institutes of Health

Publisher

SAGE Publications

Subject

Transplantation,Cell Biology,Biomedical Engineering

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