Barofold, Inc.

Sulzer Biologics, Inc.

Robert Nelson

Theodore W Randolph

Matthew B Seefeldt

Lyndal K Hesterberg

Louis Junker

Michael Lewis

Methods for refolding antibodies, particularly monoclonal antibodies, from aggregated and/or denatured preparations by subjecting the antibody preparation to high hydrostatic pressure are provided. Refolded preparations of antibodies produced by the methods described herein are also provided.

High pressure refolding of monoclonal antibody aggregates

A method for purifying bone-derived TGF-&bgr; proteins including an anion exchange process, a cation exchange process, and a reverse phase HPLC process, and optionally, a filtration process, a Heparin-Sepharose process, and/or a reverse phase HPLC desalting process. The filtration process preferably selects proteins having a nominal molecular weight between approximately 10 kilodaltons and approximately 100 kilodaltons. Preferably, the anion exchange process uses a strongly cationic resin having quaternary amine functional groups. Preferably, the cation exchange process uses a strongly anionic resin having sulfonic acid functional groups. The TGF-&bgr; proteins can be eluted from the reverse phase HPLC column with an acetonitrile solution in combination with aqueous trifluoracetic acid. The purification processes yield highly enriched TGF-&bgr;1 and TGF-&bgr;2 proteins.

Isolation of purified TGF- &bgr;1 and TGF -&bgr;2 from bone tissue

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Arvada, CO, United States of America

Robert Nelson