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    A New Methodology for Quality Control Testing of Biological and Recombinant Products

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    Manufacturing of biological therapeutic agents such as growth hormone, tissue plasminogen activator, alpha interferon, and PEGylated proteins requires new analytical methodologies for characterization and quality control of the products.

    A new methodology based on the technique of partitioning in aqueous polymer two-phase systems is recommended for quality control testing. The advantages of the methodology are that it provides unique information that is related to the biological potency, and it is rugged and simple. Here we describe the basics of the technique and the quantitative information it provides and give examples of how the technique can be applied for characterization and quality control of biological and recombinant products.


    quality control, protein characterization, partitioning, aqueous two-phase systems, dextran, polyethylene glycol, PEG, partition coefficient, hydrophobicity, protein-solvent interactions

    Author Information:

    Zaslavsky, BY
    Ameritest and Research Company, Inc., Bedford Heights, OH

    Chaiko, DJ
    Argonne National Laboratory, Argonne, IL

    Committee/Subcommittee: E48.01

    DOI: 10.1520/STP14714S