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5. Batch-to-batch consistency checks

In addition to protein secondary structure, information on several other critical quality attributes can be extracted from FTIR spectra of proteins such as glycosylation or the quantity of lipids or other excipients such as Tween. Using multivariate and statistical tools, an accurate comparison of the fingerprint provided by the FTIR spectra can be performed.

This can be realized for consistency batches which have to be produced for IND (Investigational New Drug) application to authorities but also as for optimization, scale-up or modification of the production process.

It can be applied on pure proteins but also on more complex products such as virus like particles (VLP’s) for which the consistency in terms of lipid to protein ratio can be assessed. It can also be a powerful tool for quality control of biological raw material used in diagnosis assays.