A bioprocess is a specific process that uses complete living cells or their components (e.g., bacteria, enzymes, chloroplasts) to obtain desired products. Transport of energy and mass is fundamental to many biological and environmental processes.
Areas, from food processing (including brewing beer) to thermal design of buildings to biomedical devices to pollution control and global warming, require knowledge of how energy and mass can be transported through materials (momentum, heat transfer, etc.).
Cell therapy bioprocessing is a discipline that bridges the fields of cell therapy and bioprocessing (i.e., biopharmaceutical manufacturing), and is a sub-field of bioprocess engineering. The goals of cell therapy bioprocessing are to establish reproducible and robust manufacturing processes for the production of therapeutic cells. Commercially relevant bioprocesses will:
- Produce products that maintain all of the quality standards of biopharmaceutical drugs
- Supply both clinical and commercial quantities of therapeutic cells throughout the various stages of development. The processes and production technologies must be scalable, and
- Control the cost of goods (CoGs) of the final drug product. This aspect is critical to building the foundation for a commercially viable industry.
Therapeutic cell manufacturing processes can be separated into upstream processes and downstream processes. The upstream process is defined as the entire process from early cell isolation and cultivation, to cell banking and culture expansion of the cells until final harvest (termination of the culture and collection of the live cell batch).
Aside from technology challenges, concerning the scalability of culture apparatus, a number of raw material supply risks have emerged in recent years, including the availability of GMP grade fetal bovine serum.
The downstream part of a bioprocess refers to the part where the cell mass from the upstream are processed to meet purity and quality requirements. Downstream processing is usually divided into three main sections: cell disruption, a purification section and a polishing section. The volatile products can be separated by distillation of the harvested culture without pre-treatment.
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