Raman spectroscopy-based identification of toxoid vaccine products

Abstract

Vaccines are complex biomedicines. Manufacturing is time consuming and requires a high level of quality control (QC) to guarantee consistent safety and potency. An increasing global demand has led to the need to reduce time and cost of manufacturing. The evolving concepts for QC and the upcoming threat of falsification of biomedicines define a new need for methods that allow the fast and reliable identification of vaccines. Raman spectroscopy is a non-destructive technology already established in QC of classical medicines. We hypothesized that Raman spectroscopy could be used for identification and differentiation of vaccine products. Raman maps obtained from air-dried samples of combination vaccines containing antigens from tetanus, diphtheria and pertussis (DTaP vaccines) were summarized to compile product-specific Raman signatures. Sources of technical variance were emphasized to evaluate the robustness and sensitivity in downstream data analysis. The data management approach corrects for spatial inhomogeneities in the dried sample while offering a proper representation of the original samples inherent chemical signature. Reproducibility of the identification was validated by a leave-one-replicate-out cross-validation. The results highlighted the high specificity and sensitivity of Raman measurements in identifying DTaP vaccine products. The results pave the way for further exploitation of the Raman technology for identification of vaccines in batch release and cases of suspected falsification.

Aluminum Adjuvants—‘Back to the Future’

“…Regulatory requirements for vaccines routinely include tightly controlled manufacturing and batch release processes. Two recent papers represent a tentative approach to extend the application of Raman spectroscopy and LC–MS, respectively, for the identification and quantification of tetanus, diphtheria, and pertussis (DTaP) antigens in aluminum-adjuvanted vaccines [ 94 , 95 ]. Raman spectroscopy demonstrated the potential for the identification and differentiation of complex vaccine products [ 94 ].…”

“…Two recent papers represent a tentative approach to extend the application of Raman spectroscopy and LC–MS, respectively, for the identification and quantification of tetanus, diphtheria, and pertussis (DTaP) antigens in aluminum-adjuvanted vaccines [ 94 , 95 ]. Raman spectroscopy demonstrated the potential for the identification and differentiation of complex vaccine products [ 94 ]. Raman maps obtained from air-dried samples of combination vaccines containing DtaP antigens were used to build a fingerprint of product-specific Raman signatures.…”

Bloch Surface Waves Mediated Micro‐Spectroscopy

“…Spectral measurement is among the most widely used techniques in both industrial processes and basic scientific research for applications including water quality monitoring, soil science, mineral substance detection, [1] bioanalytics [2] and medical vaccine research. [3] Although current spectrometers combined with microscopes have demonstrated impressive performance levels, more efforts should now be devoted to the distribution of the BSWs for different wavelength were measured experimentally using a leakage radiation microscope (LRM), which acts as a pre-calibrated spectrally-related database. Because of the strong dispersion and low-loss characteristics of BSWs, the unknown single and broadband spectrum can be reconstructed using an iterative algorithm.…”