Abstract
Cell-based therapy is the fastest growing segment of regenerative medicine, a field that promises to cure diseases not treated by other small molecules or biological drugs. The use of living cells as the active medicinal ingredient present great opportunities to deliver treatment that can trigger the body’s own capacity to regenerate damaged or diseased tissue. Some of the challenges in controlling the quality of the finished cell-therapy product relate to the use of a variety of raw materials including excipients, process aids, and growth promotion factors. The quality of these materials is critical for ensuring the safety and quality of the finished therapeutic products. This review will discuss some of the challenges and opportunities associated with the qualification of excipients as well as that of the ancillary materials used in manufacturing.
Highlights
Cell-therapy products offer new solutions to treat unmet medical needs by providing therapeutic products based on living cells that can promote the body’s own regenerative capacity
The goal of this review is to provide an overview of the types of excipients used in cell-therapy formulations, as well as discuss risk assessment strategies to ensure their quality, and how to mitigate their impact on the critical quality attributes of finished celltherapy products
As cell-therapy applications are increasingly introduced to the market, qualification of ancillary materials used in manufacturing should be addressed as well as excipients because of the potential for residual ancillary material in the finished products
Summary
Cell-therapy products offer new solutions to treat unmet medical needs by providing therapeutic products based on living cells that can promote the body’s own regenerative capacity. Cell-Based Therapies Formulations: Unintended Components and effectiveness of the drug delivery system during storage or use.^ While excipients that are intended to be used in celltherapy formulations that meet the definition will be qualified and tested against compendial monographs when they exist, some of the materials used in manufacturing other than the excipients may end up in the finished products. Poloxamers have been established as pharmaceutical excipients in a variety of topical dosage formations including dental and burn dressing applications (6) Some poloxamers are watersoluble and will form a gel at higher temperatures (e.g., body temperature) and can be used to deliver cells into the human body as an alternative to solid scaffolds During development of such products, the safety profile of and experience with these types of gels may be used and extrapolated to cell- and tissue-based therapies; the impact of these materials on living cells (and vice versa) needs to be evaluated. Sterility assurance and freedom from endotoxins are critical for cell- and tissuebased products more than other biologics because these products are not subject to treatments such as terminal sterilization and filtration
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