Manufacturing Cell Therapies Using Engineered Biomaterials

摘要

Emerging manufacturing processes to generate regenerative advanced therapies can involve extensive genomic and/or epigenomic manipulation of autologous or allogeneic cells. These cell engineering processes need to be carefully controlled and standardized to maximize safety and efficacy in clinical trials. Engineered biomaterials with smart and tunable properties offer an intriguing tool to provide or deliver cues to retain stemness, direct differentiation, promote reprogramming, manipulate the genome, or select functional phenotypes. This review discusses the use of engineered biomaterials to control human cell manufacturing. Future work exploiting engineered biomaterials has the potential to generate manufacturing processes that produce standardized cells with well-defined critical quality attributes appropriate for clinical testing.TrendsRecent developments in several fields, including somatic cell reprogramming and precise gene editing, are leading to novel cell-based therapies.Inherent heterogeneities in cell populations and methods for cell extraction, culture, and processing produce cell therapy products with considerable interbatch and intrabatch variability, hampering clinical translation and adoption of therapies.Standards and critical quality attributes need to be developed and verified to have clear benchmarks for the development of cell therapy products.Biomaterials could be engineered to reduce the root causes of heterogeneity, enhance functionality of cell-based therapies, and develop new standards for manufacturing.]]>