Skip to main content

The effect of formulation variables on protein stability and integrity of a model IgG4 monoclonal antibody and translation to formulation of a model ScFv

Gourbatsi, Evdoxia, Povey, Jane F., Smales, Christopher Mark (2018) The effect of formulation variables on protein stability and integrity of a model IgG4 monoclonal antibody and translation to formulation of a model ScFv. Biotechnology Letters, 40 (1). pp. 33-46. ISSN 0141-5492. E-ISSN 1573-6776. (doi:10.1007/s10529-017-2443-x) (KAR id:63854)

PDF Author's Accepted Manuscript
Language: English
Download (995kB) Preview
[img]
Preview
Official URL
http://dx.doi.org/10.1007/s10529-017-2443-x

Abstract

Objectives: There are a number of blockbuster monoclonal antibodies on the market used for the treatment of a variety of diseases. Although the formulation of many antibodies is achieved in ‘platform’ formulations, some are so difficult to formulate that it can result in an inability to develop a finished drug product. Further, a large number of antibody-inspired or-based molecules are now being developed and assessed for biotherapeutic purposes and less is understood around the required active protein drug concentrations, excipients and additives required in final product formulations.

Conclusions: The role of the different formulation conditions on maintaining protein integrity is described and using mass spectrometry shows that protein integrity is compromised under particular conditions. The implications for predicting successful formulations for protein molecules is discussed and how antibody formulations could be used to predict formulation components for novel antibody based molecules.

Item Type: Article
DOI/Identification number: 10.1007/s10529-017-2443-x
Uncontrolled keywords: Aggregation, Formulation, Monoclonal antibody, Recombinant biotherapeutic protein, ScFc, Stability
Subjects: Q Science
Divisions: Faculties > Sciences > School of Biosciences
Depositing User: Mark Smales
Date Deposited: 05 Oct 2017 13:06 UTC
Last Modified: 29 May 2019 19:39 UTC
Resource URI: https://kar.kent.ac.uk/id/eprint/63854 (The current URI for this page, for reference purposes)
Smales, Christopher Mark: https://orcid.org/0000-0002-2762-4724
  • Depositors only (login required):

Downloads

Downloads per month over past year