Biopharmaceuticals/biologics definition

Table 1.3. A summary of the definition of the terms biologic , biopharmaceuticaf and biotechnology medicine as used throughout this book. Reprinted from European Journal of Pharmaceutical Sciences, vol 15, Walsh, Biopharmaceuticals and Biotechnology, p 135-138, 2002, with permission from Elsevier Science...

The distinction between biopharmaceuticals under the jurisdiction of OBP and ONDG stems from the definition of a biological product in the PHS Act (42 USG 351 [262] (i)) a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any other tri-valent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings. Biopharmaceuticals under the jurisdiction of OBP are analogous products under this definition. 

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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