Literature DB >> 1858980

Quantitation of DNA and protein impurities in biopharmaceuticals.

J Briggs1, P R Panfili.   

Abstract

The development of drugs and biologicals for human injection generated from recombinant DNA and hybridoma technologies has resulted in new standards for product purity. We discuss the regulatory position relative to impurities in these biopharmaceuticals, focusing on the analytical goals for quantitation. Current methods for making these measurements are reviewed, and a new system designed for improved analysis is described. Assay results for both contaminating DNA and proteins are presented.

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Year:  1991        PMID： 1858980     DOI： 10.1021/ac00009a003

Source DB:  PubMed          Journal:  Anal Chem        ISSN： 0003-2700            Impact factor:   6.986


  4 in total

1.  A platform for characterizing therapeutic monoclonal antibody breakdown products by 2D chromatography and top-down mass spectrometry.

Authors:  Matthew T Mazur; Richard S Seipert; David Mahon; Qinwei Zhou; Tun Liu
Journal:  AAPS J       Date:  2012-05-12       Impact factor: 4.009

2.  Initial determination of DNA polymorphism of some Primula veris L. populations from Kosovo and Austria.

Authors:  Naim Berisha; Fadil Millaku; Bekim Gashi; Elez Krasniqi; Johannes Novak
Journal:  Physiol Mol Biol Plants       Date:  2014-12-31

3.  Quantification of trace-level DNA by real-time whole genome amplification.

Authors:  Min-Jung Kang; Hannah Yu; Sook-Kyung Kim; Sang-Ryoul Park; Inchul Yang
Journal:  PLoS One       Date:  2011-12-09       Impact factor: 3.240

4.  Identification and monitoring of host cell proteins by mass spectrometry combined with high performance immunochemistry testing.

Authors:  Katrin Bomans; Antje Lang; Veronika Roedl; Lisa Adolf; Kyrillos Kyriosoglou; Katharina Diepold; Gabriele Eberl; Michael Mølhøj; Ulrike Strauss; Christian Schmalz; Rudolf Vogel; Dietmar Reusch; Harald Wegele; Michael Wiedmann; Patrick Bulau
Journal:  PLoS One       Date:  2013-11-27       Impact factor: 3.240
  4 in total

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