Cell Therapy Manufacturing: Best Practices, Pt. 1
Best practices related to cell therapy manufacturing (CTM) include the application of strong quality management and automation in manufacturing processes. Experts also suggest the use of dissolvable microcarrier-based cell culture to increase the efficiency in the process of cell therapy manufacturing.
Strong Quality Management
- To ensure the quality of their products, manufacturers are required to fulfill the testing criteria of cell-therapy products, including meaningful measures of sterility, identity, purity, and potency.
- Every process must be performed under the supervision and always generate functional products.
- Cell-therapy manufacturers must also be consistent. The procedures of producing cell-therapy products that meet the guidelines must be precisely followed every time.
- Every manufacturer must always assess and avoid or minimize the founded risk while maintaining or optimizing the therapeutic index of the product to exile any unfavorable events as a result of manufacturing.
- Although quality management should be strict, it should allow room for improvement to guide the system’s future direction.
- Fabio Fachin, the head of Takeda cell therapy engineering and automation, advises the CTM manufacturers to utilize automated processes instead of manual ones to overcome the processing challenges.
- Even though that CTM products are specified and personalized for each patient, fully-automated processes will improve the efficiency and efficacy of each manufacturing run. Experts believe that it will allow manufacturers to deliver extensively optimized and individualized drugs for the patient with distinct indications.
- Fachin also stated that automation should be applied in every part of cell therapy production, including processing, analytics, and data management.
- The advantages of applying automation in cell therapy production include reducing the risk of microbial contamination due to the zero human contact and the fact that less skilled workers may do and perform the automated processes, thus lowering the cost of labor.
Dissolvable Microcarrier-Based Cell Culture
- The conventional use of stem cells, such as human mesenchymal stem cells (hMSCs) may produce insufficient dosage, whereas microcarrier-based culture that is processed in spinner flasks and stirred-tank bioreactors can generate high-density stem cell culture and reduce the variability and contamination risks.
- An easier and more efficient manufacturing process can be achieved through the simplified downstream activity and separation process of dissolvable microcarrier. Microcarrier can be easily dissolved in a harvest solution containing EDTA, pectinase, and a standard cell culture protease.
- Several studies also reported that dissolvable microcarrier culture can maintain normal cell karyotype and multiple potencies.
- Many experts and researchers believe that dissolvable microcarriers can lead to a more efficient, cost-effective, and less laborious cell therapy manufacturing process.
To determine the best practices concerning cell therapy manufacturing, our research team first sought information from articles and reports that were written by the experts and other relevant researchers. Our primary focus was on the practices that could improve the efficiency, efficacy, and quality of cell therapy manufacturing products. We also ensured that the articles and reports we referred were updated, as in not older than 24 months of Wonder's standard. Since our sources were written by professionals and experts, we concluded that the practices we compiled in this study are the current best practices related to cell therapy manufacturing.