Applying Raman spectroscopy to vaccine production in a Merck & Co. biomanufacturing facility

Sarah Strickler

Abstract

The quality of pharmaceutical products is directly related to the consistency and stringency of the biomanufacturing process. One such product is Protein X, a component of a new vaccine being manufactured by Merck & Co. in Elkton, Virginia. The Protein X biomanufacturing process requires 39 buffers to create the proper environment for chemical and biological reactions to occur. Merck production specialists have found that errors made during buffer preparation have the potential to undermine the quality of an entire batch of Protein X, as incorrect buffers introduce the wrong set of raw materials to the process. The goal of this study was to use Raman spectroscopy to create unique graphical fingerprints (i.e., spectra) for each Protein X buffer. The spectral library would be used for quality assurance purposes. A portable Raman instrument was used to generate spectra for five Protein X buffers from differing chemical families. Unique spectra were collected for three buffers. Study replicates, sampling, and data collection were compromised by limited Raman probe availability and the COVID-19 global pandemic. The failure to produce spectra for two samples may be due to the inadequate wavelength range offered by the portable Raman instrument. Future studies must be conducted, with a more appropriate Raman instrument, such as the Kaiser Optical Systems RamanRXN4 probe, to determine with more certainty if Raman spectroscopy could be used to generate distinct and reproducible spectra for all 39 buffers used in Protein X biomanufacturing. Reproducible spectra for the Protein X buffers would integrate an additional level of quality assurance in the biomanufacturing process, potentially saving millions in losses due to discarded batches and materials.