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Wednesday, July 16, 2008

Bio - Pharmaceutical Production

Biopharmaceutical production include two main processes; upstream process (USP) and down stream process (DSP). The upstream part of the bioprocess refers to the first step in which bio-molecules are produced, usually by microorganisms (bacteria, yeast, fungi, actinomycetes or animal/plant cell lines) in fermentors of various configurations. When these microorganisms produce the product in maximum concentration they are harvested and transferred to the downstream process. DSP refers to the recovery and purification of biopharmaceutical products. The methodology adopted for downstream processing depends on the nature of the end-product, its concentration, stability and the degree of purification desired. It is necessary to ensure that the above mentioned processes are carried out aseptically. Hence sterilization and filtration plays an important role in biopharmaceutical production. Biopharmaceuticals are also widely produced using mammalian cell lines in bioreactors. Animal cell culture (ACC) is the process of culture of animal cells outside the host animal (ex vivo) from which they were obtained. The process of ACC is carried out under strict laboratory conditions of asepsis, sterility and controlled environment involving temperature, gases and pressure. It should mimic the in vivo environment successfully such that the cells are capable of survival, proliferation and production of the desired product in a controlled manner.