X-Message-Number: 9934
Date: Tue, 23 Jun 1998 23:42:46 -0700 (PDT)
From: Doug Skrecky <>
Subject: storing antibodies 

Authors
  Duddu SP.  Dal Monte PR.
Institution
  Department of Pharmaceutical Technologies, SmithKline Beecham
  Pharmaceuticals, King of Prussia, Pennsylvania 19406, USA.
  Sarma:P:Duddu:sbphrd.com
Title
  Effect of glass transition temperature on the stability of lyophilized
  formulations containing a chimeric therapeutic monoclonal antibody.
Source
  Pharmaceutical Research.  14(5):591-5, 1997 May.
Abstract
  PURPOSE: The purpose of this study is to highlight the importance of knowing
  the glass transition temperature, Tg, of a lyophilized amorphous solid
  composed primarily of a sugar and a protein in the interpretation of
  accelerated stability data. METHODS: Glass transition temperatures were
  measured using DSC and dielectric relaxation spectroscopy. Aggregation of
  protein in the solid state was monitored using size-exclusion chromatography.
  RESULTS: Sucrose formulation (Tg approximately 59 degrees C) when stored at
  60 degrees C was found to undergo significant aggregation, while the
  trehalose formulation (Tg approximately 80 degrees C) was stable at 60
  degrees C. The instability observed with sucrose formulation at 60 degrees C
  can be attributed to its Tg (approximately 59 degrees C) being close to the
  testing temperature. Increase in the protein/sugar ratio was found to
  increase the Tgs of the formulations containing sucrose or trehalose, but to
  different degrees. CONCLUSIONS: Since the formulations exist in glassy state
  during their shelf-life, accelerated stability data generated in the glassy
  state (40 degrees C) is perhaps a better predictor of the relative stability
  of formulations than the data generated at a higher temperature (60 degrees
  C) where one formulation is in the glassy state while the other is near or
  above its Tg.

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