Smith E, Dent G. Modern Raman spectroscopy: a practical approach. John Wiley & Sons; 2019.

Hausman DS, Cambron RT, Sakr A. Application of raman spectroscopy for on-line monitoring of low dose blend uniformity. Int J Pharm. 2005;298(1):80–90.

Article  CAS  PubMed  Google Scholar 

De Beer TR, Bodson C, Dejaegher B, Walczak B, Vercruysse P, Burggraeve A, et al. Raman spectroscopy as a process analytical technology (PAT) tool for the in-line monitoring and understanding of a powder blending process. J Pharm Biomed Anal. 2008;48(3):772–9.

Article  CAS  PubMed  Google Scholar 

Radtke J, Kleinebudde P. Real-time monitoring of multi-layered film coating processes using raman spectroscopy. Eur J Pharm Biopharm. 2020;1(153):43–51.

Article  Google Scholar 

Romero-Torres S, Pérez-Ramos JD, Morris KR, Grant ER. Raman spectroscopy for tablet coating thickness quantification and coating characterization in the presence of strong fluorescent interference. J Pharm Biomed Anal. 2006;41(3):811–9.

Article  CAS  PubMed  Google Scholar 

Riolo D, Piazza A, Cottini C, Serafini M, Lutero E, Cuoghi E, et al. Raman spectroscopy as a PAT for pharmaceutical blending: Advantages and disadvantages. J Pharm Biomed Anal. 2018;5(149):329–34.

Article  Google Scholar 

Calvo NL, Arias JM, Altabef AB, Maggio RM, Kaufman TS. Determination of the main solid-state form of albendazole in bulk drug, employing Raman spectroscopy coupled to multivariate analysis. J Pharm Biomed Anal. 2016;10(129):190–7.

Article  Google Scholar 

Strachan CJ, Rades T, Gordon KC, Rantanen J. Raman spectroscopy for quantitative analysis of pharmaceutical solids. J Pharm Pharmacol. 2007;59(2):179–92.

Article  CAS  PubMed  Google Scholar 

Rafferty C, O’Mahony J, Burgoyne B, Rea R, Balss KM, Latshaw DC. Raman spectroscopy as a method to replace off-line pH during mammalian cell culture processes. Biotechnol Bioeng. 2020;117(1):146–56.

Article  CAS  PubMed  Google Scholar 

Berry B, Moretto J, Matthews T, Smelko J, Wiltberger K. Cross-scale predictive modeling of CHO cell culture growth and metabolites using R aman spectroscopy and multivariate analysis. Biotechnol Prog. 2015;31(2):566–77.

Article  CAS  PubMed  Google Scholar 

Abu-Absi NR, Kenty BM, Cuellar ME, Borys MC, Sakhamuri S, Strachan DJ, et al. Real time monitoring of multiple parameters in mammalian cell culture bioreactors using an in-line Raman spectroscopy probe. Biotechnol Bioeng. 2011;108(5):1215–21.

Article  CAS  PubMed  Google Scholar 

Berry BN, Dobrowsky TM, Timson RC, Kshirsagar R, Ryll T, Wiltberger K. Quick generation of R aman spectroscopy based in-process glucose control to influence biopharmaceutical protein product quality during mammalian cell culture. Biotechnol Prog. 2016;32(1):224–34.

Article  CAS  PubMed  Google Scholar 

André S, Lagresle S, Da Sliva A, Heimendinger P, Hannas Z, Calvosa É, et al. Developing global regression models for metabolite concentration prediction regardless of cell line. Biotechnol Bioeng. 2017;114(11):2550–9.

Article  PubMed  Google Scholar 

Rafferty C, Johnson K, O’Mahony J, Burgoyne B, Rea R, Balss KM. Analysis of chemometric models applied to Raman spectroscopy for monitoring key metabolites of cell culture. Biotechnol Prog. 2020;36(4):e2977.

Article  CAS  PubMed  Google Scholar 

Helgers H, Schmidt A, Lohmann LJ, Vetter FL, Juckers A, Jensch C, et al. Towards autonomous operation by advanced process control—process analytical technology for continuous biologics antibody manufacturing. Processes. 2021;9(1):172.

Article  Google Scholar 

André S, Saint Cristau L, Gaillard S, Devos O, Calvosa É, Duponchel L. In-line and real-time prediction of recombinant antibody titer by in situ Raman spectroscopy. Anal Chim Acta. 2015;10(892):148–52.

Article  Google Scholar 

Maruthamuthu MK, Raffiee AH, De Oliveira DM, Ardekani AM, Verma MS. Raman spectra-based deep learning: a tool to identify microbial contamination. Microbiol Open. 2020;9(11):e1122.

Article  CAS  Google Scholar 

Masucci EM, Hauschild JE, Gisler HM, Lester EM, Balss KM. Raman spectroscopy as an alternative rapid microbial bioburden test method for continuous, automated detection of contamination in biopharmaceutical drug substance manufacturing. J Appl Microbiol. 2024;135(8):lxae188.

Article  CAS  PubMed  Google Scholar 

Challa S, Potumarthi R. Chemometrics-based process analytical technology (PAT) tools: applications and adaptation in pharmaceutical and biopharmaceutical industries. Appl Biochem Biotechnol. 2013;169(1):66–76.

Article  CAS  PubMed  Google Scholar 

Food and Drug Administration. Guidance for Industry PAT. Available from: https://www.fda.gov/downloads/drugs/guidances/ucm070305.pdf. Accessed March 29, 2024.

Dayananda B, Owen S, Kolobaric A, Chapman J, Cozzolino D. Pre-processing applied to instrumental data in analytical chemistry: a brief review of the methods and examples. Crit Rev Anal Chem. 2024;54(8):2745–53.

Article  CAS  PubMed  Google Scholar 

Pétillot L, Pewny F, Wolf M, Sanchez C, Thomas F, Sarrazin J, et al. Calibration transfer for bioprocess Raman monitoring using Kennard Stone piecewise direct standardization and multivariate algorithms. Eng Rep (Hoboken). 2020;2(11):e12230.

Google Scholar 

Guo S, Beleites C, Neugebauer U, Abalde-Cela S, Afseth NK, Alsamad F, et al. Comparability of Raman spectroscopic configurations: a large scale cross-laboratory study. Anal Chem. 2020;92(24):15745–56.

Article  CAS  PubMed  Google Scholar 

Mehdizadeh H, Lauri D, Karry KM, Moshgbar M, Procopio-Melino R, Drapeau D. Generic R aman-based calibration models enabling real-time monitoring of cell culture bioreactors. Biotechnol Prog. 2015;31(4):1004–13.

Article  CAS  PubMed  Google Scholar 

Yousefi-Darani A, Paquet-Durand O, Von Wrochem A, Classen J, Tränkle J, Mertens M, et al. Generic chemometric models for metabolite concentration prediction based on Raman spectra. Sensors. 2022;22(15):5581.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Whelan J, Craven S, Glennon B. In situ raman spectroscopy for simultaneous monitoring of multiple process parameters in mammalian cell culture bioreactors. Biotechnol Prog. 2012;28(5):1355–62.

Article  CAS  PubMed  Google Scholar 

Workman JJ. A review of calibration transfer practices and instrument differences in spectroscopy. Appl Spectrosc. 2018;72(3):340–65.

Article  CAS  PubMed  Google Scholar 

Rodrigues RR, Rocha JT, Oliveira LM, Dias JC, Müller EI, Castro EV, et al. Evaluation of calibration transfer methods using the ATR-FTIR technique to predict density of crude oil. Chemom Intell Lab Syst. 2017;15(166):7–13.

Article  Google Scholar 

Leion H, Folestad S, Josefson M, Sparén A. Evaluation of basic algorithms for transferring quantitative multivariate calibrations between scanning grating and FT NIR spectrometers. J Pharm Biomed Anal. 2005;37(1):47–55.

Article  CAS  PubMed  Google Scholar 

Feudale RN, Woody NA, Tan H, Myles AJ, Brown SD, Ferré J. Transfer of multivariate calibration models: a review. Chemom Intell Lab Syst. 2002;64(2):181–92.

Article  CAS  Google Scholar 

Bergman EL, Brage H, Josefson M, Svensson O, Sparén A. Transfer of NIR calibrations for pharmaceutical formulations between different instruments. J Pharm Biomed Anal. 2006;41(1):89–98.

Article  CAS  PubMed  Google Scholar 

Alves JC, Poppi RJ. Pharmaceutical analysis in solids using front face fluorescence spectroscopy and multivariate calibration with matrix correction by piecewise direct standardization. Spectrochim Acta A Mol Biomol Spectrosc. 2013;103(15):311–8.

Article  CAS  PubMed  Google Scholar 

Steinbach D, Anderson CA, McGeorge G, Igne B, Bondi RW, Drennen JK III. Calibration transfer of a quantitative transmission Raman PLS model: direct transfer vs. global modeling. J Pharm Innov. 2017;12(4):347–56.

Article  Google Scholar 

Buckley K, Matousek P. Recent advances in the application of transmission raman spectroscopy to pharmaceutical analysis. J Pharm Biomed Anal. 2011;55(4):645–52.

Article  CAS  PubMed  Google Scholar 

da Silva VH, da Silva JJ, Pereira CF. Portable nea