Literature DB >> 2488619

Liquid chromatographic control of the identity, purity and "potency" of biomolecules used as drugs.

N A Farid1, L M Atkins, G W Becker, A Dinner, R E Heiney, D J Miner, R M Riggin.   

Abstract

The use of high-performance liquid chromatography (HPLC) in the control of rDNA-derived human insulin and human growth hormone is described. Powerful identity tests based upon reversed-phase HPLC separation of enzymatic digests have been developed. Size exclusion and reversed-phase assays are used to control higher molecular weight materials and monomeric derivatives, respectively, for both proteins. Finally, HPLC is used to control the relevant protein content, which in concert with other information controls the biopotency of the protein preparations.

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Year:  1989        PMID: 2488619     DOI: 10.1016/0731-7085(89)80082-2

Source DB:  PubMed          Journal:  J Pharm Biomed Anal        ISSN: 0731-7085            Impact factor:   3.935


  3 in total

1.  Concentrations of Intact Insulin Concurs With FDA and EMA Standards When Measured by HPLC in Different Parts of the Distribution Cold Chain.

Authors:  Alan Moses; Jesper Bjerrum; Morten Hach; Lars Holm Wæhrens; Anders Dyhr Toft
Journal:  J Diabetes Sci Technol       Date:  2018-06-28

2.  Physicochemical basis for the rapid time-action of LysB28ProB29-insulin: dissociation of a protein-ligand complex.

Authors:  D L Bakaysa; J Radziuk; H A Havel; M L Brader; S Li; S W Dodd; J M Beals; A H Pekar; D N Brems
Journal:  Protein Sci       Date:  1996-12       Impact factor: 6.725

3.  Insulin Storage: A Critical Reappraisal.

Authors:  Lutz Heinemann; Katarina Braune; Alan Carter; Amin Zayani; Laura A Krämer
Journal:  J Diabetes Sci Technol       Date:  2020-01-29
  3 in total

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