Bailey, M J A B; Cerasoli, E; Gaines Das, R*; Hills, A; Jones, C*; Kumarswami, N; Lamarre, B; LePevelen, D*; Moore, J D; Nugent, P; Rakowska, P; Robinson, C J*; Silva, M*; Tranter, G*; Wheeler, J* (2007) Strengthening quality control of biopharmaceutical products through the establishment of structure-function relationships. NPL Report. AS 5

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Abstract

Establishing relationships between data from different analytical techniques supports the selection of a suitable set of tests for the characterisation of individual biopharmaceutical preparations. In this case study a portfolio of physicochemical and biological assays was developed that examined batch-to-batch-variability in Interferonalpha preparations produced in a Pichia pastoris expression system, and in samples from external collaborators. Throughout the case study, the NPL material was compared to Chemical Reference Standards supplied by EDQM.
A review was undertaken of the industrial and regulatory debate on the application of structure-function relationships for biopharmaceuticals. The selection of key cell-based bioassays and physicochemical methods established a structure-function relationship for the class of model system used within this project.

Item Type:	Report/Guide (NPL Report)
NPL Report No.:	AS 5
Keywords:	biopharmaceutical, bioassay, structure
Subjects:	Biotechnology Biotechnology > Biopharmaceutical Manufacturing and Characterisation
Last Modified:	02 Feb 2018 13:15
URI:	https://eprintspublications.npl.co.uk/id/eprint/3940