BIOT 15 |
| Amgen has learned recently that tungsten forming pins are used in the manufacture of glass pre-filled syringe barrels and that residual tungsten from the process can lead to protein aggregation in some therapeutic protein formulations. This paper discusses: 1) the source of tungsten in syringe manufacture, 2) how Amgen confirmed the link between aggregated proten and residual tungsten, 3) the effect of fill-finish processes on product exposure to tungsten, 4) development of methods to analyze residual tungsten in empty syringes, 5) the testing of drug products to determine sensitivity to tunsten, 6) the proposed aggregation mechanism, and 7) how this experience has changed Amgen's paradigm for managing relation supplier relationships. |
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Biophysical and Biomolecular Symposium: Protein Stability
8:00 AM-11:10 AM, Sunday, August 19, 2007 BCEC -- 107 A/B, Oral
Division of Biochemical Technology |