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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).
This mechanism for producing consistent product quality & reducing waste presents a good case for utilising continuous manufacturing technologies. The control of a steady state process when you understand the upstream & downstream effects is an easier task as common cause variability is easier to define and monitor.
Downstream processing refers to the recovery and the purification of biosynthetic products, particularly pharmaceuticals, from natural sources such as animal tissue, plant tissue or fermentation broth, including the recycling of salvageable components as well as the proper treatment and disposal of waste.
Upstream extracellular signaling transduce a variety of intracellular cascades. [1] Receptors and ligands are common upstream signaling molecules that dictate the downstream elements of the signal pathway. A plethora of different factors affect which ligands bind to which receptors and the downstream cellular response that they initiate.
A bioprocess is composed mainly of three stages—upstream processing, bioreaction, and downstream processing—to convert raw material to finished product. [11] The raw material can be of biological or non-biological origin. It is first converted to a more suitable form for processing.
Insulin crystals. Amongst the earliest uses of biotechnology in pharmaceutical manufacturing is the use of recombinant DNA technology to modify Escherichia coli bacteria to produce human insulin, which was performed at Genentech in 1978. [1]
Pfizer Inc. (NYSE: PFE) discovers, develops, manufactures, markets, distributes, and sells biopharmaceutical products worldwide and pays a rich 6.61% dividend, which has risen yearly for the past ...
Upstream and downstream can refer to: Molecular biology. Upstream and downstream (DNA), determining relative positions on DNA; Upstream and downstream (transduction) ...