﻿It is often derived from bovine, human, or horse sources and is processed and treated in various ways (irradiated, warmth inactivated, etc.). small academic or biotech researcher in an effort to aid in cell therapy product development. Items to be addressed include common good developing practice (GMP) processes, technology transfer, cell sources, isolation procedures, bio- and cryopreservation, media, cytokines, sera, serum-free media, scalable platforms, matrices, cell densities, harvesting, genetic alterations, characterization/phenotypic assays, and security assays (Fig. 1). Although each process is not standard for all those cell types, we compare multiple cell types and propose alternate methods where available. Although cell therapy developing has relied greatly on biologic developing/bioprocess, we compare and contrast how shared processes might be beneficial. For example, adherent cells are commonly utilized for biologic production; however, the cells are normally not Abiraterone (CB-7598) recovered. In the case of cell therapy, developing adherent mesenchymal stem cells (MSCs) becomes a serious scalability issue. Alternate adherent scale-up/scale-out systems are available. Alternatively, some groups have successfully adapted MSCs to suspension cultures. Open in a separate window Physique 1. This flowchart represents a typical cell therapy product process and production layout. Each step has multiple actions within it and can be variable depending on the cell type. GMP Processes, Definition, and Cell Therapy-Specific Processes Overview of GMP What is GMP and how does one implement it for developing autologous cell therapies? GMP is usually defined by Medicines and Healthcare Products Abiraterone (CB-7598) Regulatory Agency (MHRA) in the United Kingdom as that a part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality requirements appropriate to Abiraterone (CB-7598) their intended use and as required by the marketing authorization or product specification. GMP is concerned with both production and quality control. Both the U.S. Food and Drug Administration (FDA) and the European Abiraterone (CB-7598) Medicines Agency (EMA) have comparable definitions. As defined, GMP guidelines cover not only the actual physical process of making the drug but also the quality assurance that GPR44 the drug is produced under conditions that are consistent, safe, and effective for their intended use. With this intention, GMP guidelines include nearly all aspects of drug developing, including but not limited to the quality control and assurance system, manufacturing facilities, gear and devices used in the process, raw materials, media and medium supplements, storage, and shipping. In the United States, guidelines for cell-based therapeutics are regulated by the FDA (http://www.fda.gov) and are encompassed in the drug manufacturing regulations as described in Title 21 of the Code of Federal Regulations (CFR) in several sections (21CFR210, 211, 610, and 820), including the use of human tissue and cell products (21CFR1271). The EMA (http://www.ema.europa.eu/ema) for the European Union and the MHRA (http://www.mhra.gov.uk) publishes comparable guidelines. Both the EMA and MHRA consider cell therapy products to be advanced-therapy medicinal products and examined by the Committee for Advanced Therapies. Additional guidance for cell and gene therapies may Abiraterone (CB-7598) be found in Regulation (EC) No. 1394/2007. It is important to understand these regulations early in the product development phase in order to ensure that compliance can be achieved. If issues arise, they can be addressed prior to production. The intent of this review is not to provide specific guidance on how to navigate through the regulatory approval process but rather to point readers to sources of information so that they may become familiar with regulations and guidance specific to their products as they develop.

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