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Providing enabling technologies to support you from Discovery to Delivery.

Downstream Process

SolutionsDownstream Process

Downstream processing is the initial step of a biomanufacturing process to harvest cell culture containing highly-expressed active pharmaceutical ingredients (APIs). This is then purified and concentrated for final product formulation and commercialization.

The entire phase requires cGMP compliance to ensure that these living organisms are maintained under safe and sterile conditions. The equipment to be used in isolation, purification, and filtration can be enclosed in a cell therapy aseptic isolator during the whole process. This technology will prevent occupational contamination and unwanted air particles to mix with the isolates.

Goals of the Downstream Process

  • Capture of Recovery – This involves the accelerated segregation of the product of the lead compound from the cells. The goal is/are the following:
    • Elimination of all micro-particulates and colloidal materials (a mixture with one substance uniformly dispersed throughout another).
    • Elimination of the majority of water, growth medium supplements, and small molecule solutes via product concentration.
    • Separation of product away from proteolytic enzymes or other degradative elements.
  • Intermediate Purification – This involves the elimination of bulk contaminants, including host cell proteins and adventitious viruses, as well as any potential leaching foreign bodies from other in-process materials. Often there are microscopic (but finite) specific level of leached ligand from the capture resin that can be moderately bound or otherwise co-eluted with the lead compound.
  • Polishing – This involves the elimination of trace contaminants and impurities, including inactive or unwanted isoform of the desired therapeutic or common impurities, including fragments or other chemical modifications thereof.