Pharmaceutical Technology - May 2020

Pharmaceutical Technology – Biologics and Sterile Drug Manufacturing

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30 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2020 P h a r mTe c h . c o m Quality T hough cell therapy is a recent innovation, with the first therapies approved by FDA in 2017, the use of human cells has been a standard of care for decades in hematol- ogy and oncology (1). A cell therapy can be derived from a variety of sources, including hematopoietic, skeletal muscle, neural, and mesenchymal stem cells (i.e., adult stem cells that differentiate into structures such as connective tissues, blood, lymphatics, bone, and cartilage). Lymphocytes, dendritic cells, and pancreatic islet cells can also function as source cells. Many cell-based therapies cur- rently in development are based on induced pluripotent stem cells (iPSCs), adult cells that have been genetically reprogrammed back into a pluripotent state (i.e., so that they can differentiate into one of many types of cells in vivo) (2). There are two types of cell therapy: autologous and allogeneic. In au- tologous cell therapy, the source cells come from the patient to whom the therapy is administered. In allogeneic cell therapy, the source ma- terials are cells from an independent donor, and the therapy can be administered to a number of patients. Given the urgency of ensuring good patient outcomes, it is es- sential to have a strategy in place for preventing contamination of source cells, as well as the resulting cell therapies. Any biocontami- nants found in critical zones of the cleanroom environment can endanger patients' lives, and have a devastating impact on finances and reputation (3). Maintaining an aseptic environment is critical to minimizing the risk of contamination from extrinsic sources. Intrinsic contamination risks also exist in the cell manufacturing processes, however, primar- LOOKER_STUDIO - STOCK.ADOBE.COM Detecting Contamination in Cell Therapies Feliza Mirasol A variety of assays should be used to detect bacterial, fungal, and viral contaminants in the human source cells used for cell therapies.

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