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Photo credit: CinnaGen

Upstream Process:

For biopharmaceutical production there are two major steps which are designated as upstream and downstream processes. Upstream is the process in which a biopharmaceutical is produced by cell lines manipulated through recombinant DNA technology.

The majority of biopharmaceuticals are of protein nature and are expressed in recombinant hosts. For expressing certain biopharmaceutical proteins, microbial and mammalian systems are attractive because of various reasons.

However, there are things microbes simply are not able to do. Many biopharmaceutical molecules are too large and complex to be made by simple prokaryotic bacteria, or even the lower eukaryotic forms such as fungi and yeasts. Complex biomolecules, such as functional mAbs or highly glycosylated proteins like recombinant proteins, require the post-translational metabolic machinery only available in mammalian cells. Glycosylation of monoclonal antibodies and recombinant proteins are important for their biological function and pharmacokinetics.

Mammalian cells have become the dominant system for producing recombinant proteins for clinical application because of their capacity to properly fold and assemble proteins and add human like post-translational modifications.

CinnaGen owns the technology of upstream process as per following:

Expression technology which includes high titer cell selection, clone selection, choosing high expression vectors and GMP cell banking system (Working and Master cell banks)

 Cell growth technology which consists of: culturing the cells with high concentration, different feeding strategy, media optimization and control of glycosylation patterns of proteins expressed by recombinant cell lines.

Also we are equipped with two different systems of culturing the cells and manufacturing biopharmaceuticals. One is referred as roller culture system which enables us to manufacture in roller bottles.

The other one is state of the art bioreactor systems with different volumes which increase our capacity of cell culture to 15000L. There are a series of them which consists of seed and production bioreactors.

Jan2016 / Operation Department / CinnaGen