Reference Protocol to Assess Analytical Performance of Higher Order Structural Analysis Measurements:Results from an Interlaboratory Comparison

Groves, K. and Ashcroft, A.E. and Cryar, A. and Sula, A. and Wallace, B.A. and Stocks, B.B. and Burns, C. and Cooper-Shepherd, D. and De Lorenzi, E. and Rodriguez, E. and Zhang, H. and Ault, J.R. and Ferguson, J. and Phillips, J.J. and Pacholarz, K. and Thalassinos, K. and Luckau, L. and Ashton, L. and Durrant, O. and Barran, P. and Dalby, P. and Vicedo, P. and Colombo, R. and Davis, R. and Parakra, R. and Upton, R. and Hill, S. and Wood, V. and Soloviev, Z. and Quaglia, M. (2021) Reference Protocol to Assess Analytical Performance of Higher Order Structural Analysis Measurements:Results from an Interlaboratory Comparison. Analytical Chemistry, 93 (26). pp. 9041-9048. ISSN 0003-2700

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Abstract

Measurements of protein higher order structure (HOS) provide important information on stability, potency, efficacy, immunogenicity, and biosimilarity of biopharmaceuticals, with a significant number of techniques and methods available to perform these measurements. The comparison of the analytical performance of HOS methods and the standardization of the results is, however, not a trivial task, due to the lack of reference protocols and reference measurement procedures. Here, we developed a protocol to structurally alter and compare samples of somatropin, a recombinant biotherapeutic, and describe the results obtained by using a number of techniques, methods and in different laboratories. This, with the final aim to provide tools and generate a pool of data to compare and benchmark analytical platforms and define method sensitivity to structural changes. Changes in somatropin HOS, induced by the presence of zinc at increasing concentrations, were observed, both globally and at more localized resolution, across many of the methods utilized in this study and with different sensitivities, suggesting the suitability of the protocol to improve understanding of inter- and cross-platform measurement comparability and assess analytical performance as appropriate. © 2021 The Authors. Published by American Chemical Society.

Item Type:
Journal Article
Journal or Publication Title:
Analytical Chemistry
Uncontrolled Keywords:
/dk/atira/pure/subjectarea/asjc/1600/1602
Subjects:
ID Code:
157756
Deposited By:
Deposited On:
29 Jul 2021 13:35
Refereed?:
Yes
Published?:
Published
Last Modified:
20 Oct 2021 06:09