Biopharmaceutical proteins definition

Mammalian cells allow the production of complex biopharmaceutical proteins. Advances in the generation of stable recombinant clones, media formulation, and process and fermentor design have significantly increased yields over the past two decades. Exciting networks across the pro-teome and transcriptome are elucidated that show the enormous potential still hidden in mammalian cells. The near future will definitely show further improvement with cell lines specifically designed and metabolically engineered for industrial-scale production of biopharmaceuticals. 

A wide range of analytical techniques is used in the characterization of recombinant proteins, including proteomics tools. By definition, proteomics is the simultaneous analysis of complex protein mixtures like tissue extracts, cell lysates, subcellular Iractions or biological fluids at a given time and under precisely defined conditions. Therefore, proteomics tools can also be applied to quantify and identify complex mixtures of proteins in a purified biopharmaceutical. Purify analysis occurs at three stages of the production process during the production (in-process controls), at the end of the purification process on the bulk material, and after the final formulation on the finished product. 

While the tenn biopharmaceutical has been defined in various ways in the literature, the definition provided by Walsh (2003) is useful for our purposes The term biopharmaceutical refers to protein or nuclei acid based pharmaceutical substances used for therapeutic or in vivo diagnostic purposes, which are produced by means other than direct extraction from natural (non-engineered) biological sources. Most biopharmaceuticals have been discovered as a direct consequence of increased knowledge and understanding of the body s molecular mechanisms that underpin states of health and disease. 

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