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The regulation of biological products

European Journal of Clinical Microbiology & Infectious Diseases, 1990
The purpose of regulations for biological products is the same as that for any other medicinal or related products: the protection of recipients of the products. The entry into the age of molecular biology with its attendant development and manufacturing technology has placed new demands on regulatory agencies and related industry personnel.
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Digital-to-biological converter for on-demand production of biologics

Nature Biotechnology, 2017
Manufacturing processes for biological molecules in the research laboratory have failed to keep pace with the rapid advances in automization and parellelization. We report the development of a digital-to-biological converter for fully automated, versatile and demand-based production of functional biologics starting from DNA sequence information ...
Kent S, Boles   +8 more
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On the interchangeability of biologic drug products

Statistics in Medicine, 2012
Interchangeability of drug products has very different features with small molecules and with biologicals. With small‐molecule drugs, a statement of bioequivalence generally indicates therapeutic equivalence and interchangeability. In contrast, with the much more sensitive and complicated biological drugs, a declaration of biosimilarity emphatically ...
Endrenyi L   +3 more
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The Gastrins: Their Production and Biological Activities

Annual Review of Physiology, 2001
▪ Abstract  Gastric epithelial organization and function are controlled and maintained by a variety of endocrine and paracrine mediators. Peptides encoded by the gastrin gene are an important part of this system because targeted deletion of the gene, or of the gastrin-CCKB receptor gene, leads to decreased numbers of parietal cells and decreased ...
G J, Dockray   +3 more
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Biological production of 2,3-butanediol

Applied Microbiology and Biotechnology, 2001
2,3-Butanediol (2,3-BDL), which is very important for a variety of chemical feedstocks and liquid fuels, can be derived from the bioconversion of natural resources. One of its well known applications is the formation of methyl ethyl ketone, by dehydration, which can be used as a liquid fuel additive. This article briefly reviews the basic properties of
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