bioprocessing

Bioprocessing is the use of living systems or their components to manufacture products. It covers the design, development, and operation of processes that utilize cells, tissues, or enzymes to produce substances at commercial scale. The workflow is typically divided into upstream processing, which includes cultivation of cells or microorganisms under controlled conditions, and downstream processing, which entails purification and formulation of the final product.

Common hosts include bacteria (Escherichia coli), yeast (Saccharomyces cerevisiae), mammalian cells (such as CHO), plant cells, and isolated enzymes or cell-free systems. Bioreactors or fermenters provide controlled environments for growth, with monitoring of parameters such as temperature, pH, dissolved oxygen, and nutrient supply.

Techniques used include batch, fed-batch, perfusion, and continuous culture, along with media optimization and feed strategies. Downstream processing uses clarification, filtration, precipitation, and chromatographic purification to achieve desired purity and activity.

Applications span biopharmaceuticals (monoclonal antibodies, vaccines, recombinant proteins), industrial enzymes, nutraceuticals, biofuels, and specialty polymers. Safety and regulatory considerations emphasize quality assurance, process validation, and compliance with good manufacturing practices, with defined critical quality attributes and critical process parameters.

Environmental and economic factors are also considered, including waste treatment, resource efficiency, scalability, and cost of goods. Ongoing innovations in bioprocessing focus on increasing yield, reducing development time, enabling continuous operations, and supporting personalized or precision therapeutics.