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  • 1 Center for Biologics Evaluation and Research, FDA, Rockville USA 20852 MD 1401 Rockville Pike Rockville USA 20852 MD 1401 Rockville Pike
  • | 2 Conseiller Scientifique Lausanne Switzerland CH-1010 Chemin de Verdonnet 2 Lausanne Switzerland CH-1010 Chemin de Verdonnet 2
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Abstract  

Thermogravimetry (TG), thermogravimetry/mass spectrometry (TG/MS), and loss-on-drying methodology are used to provide residual moisture results for freeze-dried biological products regulated by the US Food and Drug Administration. Residual moisture specifications must be met in order to ensure freeze-dried biological product potency and stability throughout the licensed product's shelf life. TG, TG/MS, loss-on-drying and vapor pressure moisture measurements are compared for a BCG Vaccine. Comparisons are made between residual moisture data for the freeze-dried cake and vapor pressure moisture determinations in the space above the freeze-dried cake in the final container. Vapor pressure moisture precision data is presented for α-interferon and BCG vaccine. Impact of residual moisture and vapor pressure moisture upon product stability is presented.