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Enhanced bio-manufacturing through advanced multivariate statistical technologies

Lookup NU author(s): Professor Elaine Martin, Emeritus Professor Julian Morris

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Abstract

The paper describes the interrogation of data, from a reaction vessel producing an active pharmaceutical ingredient (API), using advanced multivariate statistical techniques. Due to the limited number of batches available, data augmentation was used to increase the number of batches thereby enabling the extraction of more subtle process behaviour from the data. A second methodology investigated was that of multi-group modelling. This allowed between cluster variability to be removed, thus allowing attention to focus on within process variability. The paper describes how the different approaches enabled the realisation of a better understanding of the factors causing the onset of an impurity formation to be obtained as well demonstrating the power of multivariate statistical data analysis techniques to provide an enhanced understanding of the process. (C) 2002 Elsevier Science B.V. All rights reserved.

Publication metadata

Author(s): Martin EB; Morris AJ

Publication type: Article

Publication status: Published

Journal: Journal of Biotechnology

Year: 2002

Volume: 99

Issue: 3

Pages: 223-235

ISSN (print): 0168-1656

ISSN (electronic): 1873-4863

Publisher: Elsevier BV

URL: http://dx.doi.org/10.1016/S0168-1656(02)00212-2

DOI: 10.1016/S0168-1656(02)00212-2

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