Figure 1: Preprocessed bioreactor data collected from three different units.
by Kevin Broadbelt, Global Applications Scientist – Biopharma, Thermo Fisher Scientific
Biopharmaceutical manufacturing processes depend on living organisms to generate the product, making them extremely complex and susceptible to even slight variations in the bioreactor environment. Any changes in conditions can significantly impact yield and quality, with costly knock-on effects that include failed batches, inefficient use of resources and end products that don’t meet quality specifications. As a result, it is crucial that every aspect of the reaction conditions is fully understood to ensure optimal process control and consistent end-product quality. Biologics manufacture therefore depends on rigorous process development to optimize bioproduction workflows.
In-line and at-line monitoring of materials plays a vital role in this process and can often be streamlined by adopting real-time process analytical technologies (PATs), such as Raman spectroscopy. This technique allows early identification of issues that could lead to costly batch failures, enabling preventative action to be taken and improving efficiency. To date, process Raman as a PAT tool has largely been employed for upstream cell cultivation and harvesting in bioreactors, but it also has potential for downstream extraction of drug substance, and purification processes.
An introduction to Raman
Raman spectroscopy is a common analytical technique that allows researchers and manufacturers to define the chemical composition of solid, liquid or gaseous materials. The technique involves using a fiber-optic cable to direct laser light at a sample. The energy from the laser causes covalently bonded molecules in the sample to vibrate and scatter the light; this can be either elastic scattering – with the energy of the molecule unchanged after interaction with the photon – or inelastic scattering, where the molecule absorbs some of the energy and the scattered photon loses energy. The inelastically scattered light is collected and interpreted by a detector, generating a Raman spectrum that is unique to each molecule. This molecular fingerprint enables both qualitative identification of a given substance, and quantification of the amount of the analyte of interest present.
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