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Manufacture Biosimilars, Clinical Trials, Formulation, Small Molecules

Taylor Dispersion Analysis for assessing the self-association and stability of Insulin

sponsored by Malvern Panalytical

Introduction

Taylor Dispersion Analysis (TDA) is an orthogonal technique for sizing and stability studies of biomolecules in solution. Studies have shown that hydrodynamic radius (Rh) measurements from TDA on monodisperse systems such as monoclonal antibodies (mAbs), are comparable to data obtained using the well-established and complementary technique of Dynamic Light Scattering (DLS).

Protein stability is one of the primary concerns during biopharmaceutical development, as it negatively impacts upon immunogenicity and potency of the biotherapeutic. Screening of candidate molecules for developability under a variety formulation conditions is therefore a critical aspect in early stages of the development pipeline.

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  1. A. Lavoisier, J-M Schlaeppi, ‘Early developability screen of therapeutic antibody candidates using Taylor Dispersion Analysis and UV area imaging detection’ mAbs 7:1, 77-83 (2015)
  2. A. Hawe, W.L. Hulse, W. Jiskoot, R.T. Forbes, ‘Taylor Dispersion Analysis compared to Dynamic Light Scattering for the size analysis of therapeutic peptides and proteins and their aggregates’ Pharm Res 28: 2302-2310 (2011)
  3. A.M. Gualandi-Signorini, G. Giorgi, ‘Insulin formulations – a review’ European Review for Medical and Pharmacological Sciences 5: 73-83 (2001)
  4. Malvern White Paper ‘Understanding Taylor Dispersion Analysis’ www.malvern.com
  5. A. Ahmad, I.S. Millett, S. Doniach, V.N. Uversky, A.L. Fink, ‘Stimulation of Insulin Fibrillation by Urea-induced Intermediates’ Journal of Biological Chemistry 279: 14999-15013 (2004)
  6. M.M. Varughese, J. Newman, ‘Inhibitory Effects of Arginine on the Aggregation of Bovine Insulin’ Journal of Biophysics Volume 2012, Article ID 434289, 7 pages (2012)

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