Biotechnological pharmaceuticals physical

Combinatorial chemistry and parallel synthesis are now the dominant methods of compound synthesis at the lead discovery stage [2]. The method of chemistry synthesis is important because it dictates compound physical form and therefore compound aqueous solubility. As the volume of chemistry synthetic output increases due to combinatorial chemistry and parallel synthesis, there is an increasing probability that resultant chemistry physical form will be amorphous or a neat material of indeterminate solid appearance. There are two major styles of combinatorial chemistry - solid-phase and solution-phase synthesis. There is some uncertainty as to the true relative contribution of each method to chemistry output in the pharmaceutical/biotechnology industry. Published reviews of combinatorial library synthesis suggest that solid-phase synthesis is currently the dominant style contributing to about 80% of combinatorial libraries [3]. In solid-phase synthesis the mode of synthesis dictates that relatively small quantitities of compounds are made. 

Saunders LM, Hendren RW. Protein Delivery Physical Systems, Pharmaceutical Biotechnology, Vol. 10, Plenum Press, New York, 1997. 

Yamamoto, O. (1992), Effect of radiation on protein stability, in Ahern,T. J., and Manning, M. C. Eds., Pharmaceutical Biotechnology, Vol. 2, Stability of Protein Pharmaceuticals. Part A Chemical and Physical Pathways of Protein Degradation, Plenum, New York. 

Pharmaceuticals 1, 4, 8, 11, 20, 23, 65-67, 109, 111, 123, 141, 152 Pharmacia 27 Pharmacia, Upjohn 27 Physical integration 42 Plant biotechnology 67-71, 77 Plant closures 44 Plant management 152-161 Plant operations 151 Plant specialization 180 Plasticsnet 80... 

USP-NF monographs include assays and various analytical methods—identification, dissolution, content uniformity, etc. USP-NF also provides guidance and standards on biotechnology, radiopharmaceuticals, pharmacy compounding, and pharmaceutical waters. General chapters outline requirements for microbiological, biological, chemical, and physical tests and assays. 

Clarification of rough beer, vinegar and pasteurization of clarified beer by cross-flow ultrafiltration are also very common processes utilizing hollow fiber ultrafiltration. As seen in Table 1, an important number of membrane manufacturers specialize in medical and pharmaceutical applications. In pharmaceutical and biotechnology industries, hollow fiber membranes are used for the concentration, separation, and purification of physiological activators such as antibiotics, vaccines, enzymes, proteins and peptides, as well as blood purification (hemofiltration). As a physical barrier for bacteria and viruses, membranes are also a popular option for the production of purified water for hospitals and pharmacies. 

The stability of biotechnology-produced products, proteins (macromolecules), and peptides is unique when compared with conventional pharmaceuticals (small molecules). Protein degradation by both chemical and physical processes leads to the loss of biological activity, whereas peptides decompose only through chemical instability with loss of efficacy and produce undesirable biological effects. 

Delivery of large-molecular-weight, biotechnology-produced drugs info the body is difficult because of the poor absorption of these compounds, the acid lability of peptide bonds, and the rapid enzymatic degradation of these drugs in the body. In addition, protein pharmaceuticals are susceptible to physical instability, complex feedback control mechanisms, and peculiar dose-response relationships. 

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