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The success of cell therapy products, including CAR-T cell therapy, is significantly dependent upon the material selection strategies set in the early stages of development. These strategies encompass raw materials (i.e., ancillary) throughout the production process. To facilitate the translation into clinical trials and beyond, developing a raw material selection strategy that considers the end goal is critical. Most strategies emphasize the use of the highest grades of materials available as early as possible; however, this may not always be feasible. Accounting for material-grade transitions can help balance both performance and costs when moving onto the next stage.

Raw and ancillary materials refer to materials that are used during the production process but that are not present in the final cell therapy product. Overall, these materials are not explicitly regulated. However, there are guidelines that provide recommendations on material selection due to its significant impact on safety, purity, and potency in the final product. When selecting raw materials for use, cell therapy manufacturers should deliberate on the biosafety characteristics and the risks each material could introduce.

For early-stage research and development of cell therapy, research-use only (RUO) materials are most commonly used. However, RUO materials do not meet the regulation of clinical phases. The FDA recommends using FDA-approved or clinical-grade materials; therefore, the best option is utilizing good manufacturing practice (GMP) or current GMP (cGMP) grade materials.

GMP products are manufactured under a stringent quality management system that is significant costlier than RUO counterparts. Implementing GMP products in the early preclinical, or even clinical, stages may not always be feasible. Therefore, transitioning between RUO products to GMP products is important. Seeking qualified, reliable, and consistent raw material manufacturers is the material-selection strategy and is a key component in developing a cell therapy product.

ACROBiosystems offers a wide range of raw materials and tools needed for cell therapy products, including cytokines, nucleases, and activation beads. We provide several grades of materials, including both premium and GMP grades. Our premium-grade proteins originate from the same clone, sequence, and expression system as our GMP products. The main difference is the available documentation provided with our GMP products. This means developers utilizing our premium-grade products can easily transition into GMP products for use in CMC or clinical stages without more comparability studies of the manufacturing process.

Cell therapy products are a type of living drugs that are under increasing scrutiny from regulatory bodies due to both their potential and safety concerns. As such, there are numerous pitfalls when developing a cell therapy product. Having a long-term material- and process-selection is critical to translating a product into clinical and commercialization phases. To assist our customers throughout the entire development process, ACROBiosystems has developed a series of high-quality cell therapy products that maximize bioactivity and potency while preserving research budgets.

For additional information: http://www.acrobiosystems.com

Read more from the original source:
Selection and Evaluation of Ancillary Materials for Cell and Gene Therapy Research - Inside Precision Medicine

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