Real-time quality control for chemical and biotechnological processes: a brief review

Agnieszka Kołodziejczak-Radzimska; Beata Rukowicz; Sharon Davin

doi:10.20883/medical.e901

Authors

Agnieszka Kołodziejczak-Radzimska Institute of Chemical Technology and Engineering, Faculty of Chemical Technology, Poznan University of Technology, Poland https://orcid.org/0000-0002-5338-0436
Beata Rukowicz Institute of Chemical Technology and Engineering, Faculty of Chemical Technology, Poznan University of Technology, Poland https://orcid.org/0000-0002-1304-3638
Sharon Davin APC – Applied Process Company Ltd., Dublin, Ireland https://orcid.org/0000-0003-0578-8741

DOI:

https://doi.org/10.20883/medical.e901

Keywords:

Process Analytical Technology (PAT), Real-Time Process Control, Online Analysis, Monitoring Techniques

Abstract

Monitoring critical process parameters of chemical and biotechnological processes is an essential tool at every stage of drug manufacturing technology. The aim of Process Analytical Technology (PAT) is to provide effective tools, such as multidimensional data analysis, modern analytical methods, and monitoring tools, for the continuous improvement of process understanding and knowledge. Among the methods of wide interest are optical and spectroscopic techniques that can be used in the control of chemical and biotechnological processes. The selection of the appropriate method is crucial and depends on many factors, including the nature of the process, the number of variables, and analytical limitations. This review focuses on a brief and precise characterization of spectroscopic and optical methods that can be applied to monitoring and control of chemical and biotechnological processes.

Downloads

Download data is not yet available.

References

Mali AS, Jagtap M, Karekar P, Maruska A. A brief review on process analytical technology (PAT). Int J Curr Pharm Res 2016;8:10.

Mazivila SJ, Santos JML. A review on multivariate curve resolution applied to spectroscopic and chromatographic data acquired during the real time monitoring of evolving multi component processes from process analytical chemistry to process analytical technology. Trends Anal Chem 2022;157:116698. DOI: https://doi.org/10.1016/j.trac.2022.116698

Nagy B, Galata DL, Farkas A, Nagy ZK. Application of artificial neural networks in the process analytical technology of pharmaceutical manufacturing—a review. AAPS J 2022;24:74. DOI: https://doi.org/10.1208/s12248-022-00706-0

Simon LL, Pataki H, Marosi G, Meemken F, Hungerbühler K et al. Assessment of recent process analytical technology (PAT) trends: a multiauthor review. Org Process Res Dev 2015;19:3. DOI: https://doi.org/10.1021/op500261y

Feng H, Mohan S. Application of Process Analytical Technology for pharmaceutical coating: challenges, pitfalls, and trends. AAPS Pharm Sci Tech 2020;21:179. DOI: https://doi.org/10.1208/s12249-020-01727-8

Hou G, Power G, Barrett M, Glennon B, Morris G, Zhao Y. Development and characterization of a single stage mixed suspension, mixed-product-removal crystallization process with a novel transfer unit. Cryst Growth Des 2014,14:1782. DOI: https://doi.org/10.1021/cg401904a

Kyoda Y, Costine A, Fawell P, Bellwood J, Das G. Using focused beam reflectance measurement (FBRM) to monitor aggregate structures formed in flocculated clay suspensions. Miner Eng 2019;138:148. DOI: https://doi.org/10.1016/j.mineng.2019.04.045

Bodmeier R. Effect of solvent type on preparation of ethyl cellulose microparticles by solvent evaporation method with double emulsion system using focused beam reflectance measurement. Polym Int 2017;66:1448. DOI: https://doi.org/10.1002/pi.5436

Melchuna A, Cameirao A, Herri J-M, Glenat P. Topological modeling of methane hydrate crystallization from low to high water cut emulsion systems. Fluid Phase Equilib 2016;413:158. DOI: https://doi.org/10.1016/j.fluid.2015.11.023

Kim EJ, Kim JH, Kim M-S, Jeong SH, Choi DH. Process analytical technology tools for monitoring pharmaceutical unit operations: a control strategy for continuous Process verification. Pharmaceutics 2021;13:919. DOI: https://doi.org/10.3390/pharmaceutics13060919

Sirota E, Kwok T, Varsolona RJ, Whittaker A, Andreani T, Quirie S, Margelefsky E, Lamberto DJ. Crystallization process development for the final step of the biocatalytic synthesis of islatravir: comprehensive crystal engineering for a low-dose drug. Org Process Res Dev 2021;25:308. DOI: https://doi.org/10.1021/acs.oprd.0c00520

Muhaimin M, Chaerunisaa AY, Bodmeier R. Real-time particle size analysis using focused beam reflectance measurement as a process analytical technology tool for continuous microencapsulation process. Sci Rep 2021;11:19390. DOI: https://doi.org/10.1038/s41598-021-98984-9

https://www.mt.com/int/en/home/products/L1_AutochemProducts/particle-size analyzers/particletrack-fbrm.html

Santos D, Maurício AC, Sencadas V, Santos JD, Fernandes MH, Gomes PS. Spray drying: an overview. In biomaterials: physics and chemistry—New Edition; InTech: London, UK, 2018. DOI: https://doi.org/10.5772/intechopen.72247

Gao Y, Zhang T, Ma Y, Xue F, Gao Z, Hou B, Gong J. Application of PAT-based feedback control approaches in pharmaceutical crystallization. Crystals 2021;11:221. DOI: https://doi.org/10.3390/cryst11030221

Gerzon G, Sheng Y, Kirkitadze M. Process Analytical Technologies - Advances in bioprocess integration and future perspectives. J Pharm Biomed Anal 2021;207:114379. DOI: https://doi.org/10.1016/j.jpba.2021.114379

Su W, Hao H, Barrett M, Glennon B. The impact of operating parameters on the polymorphic transformation of D-mannitol characterized in situ with Raman spectroscopy, FBRM, and PVM. Org Process Res Dev 2010;14:1432. DOI: https://doi.org/10.1021/op100228f

Liu W, Wei H, Zhao J, Black S, Sun C. Investigation into the cooling crystallization and transformations of carbamazepine using in situ FBRM and PVM. Org Process Res Dev 2013;17:1406. DOI: https://doi.org/10.1021/op400066u

Nikita S, Mishra S, Gupta K, Runkana V, Gomes J, Rathote AS. Advances in bioreactor control for production of biotherapeutic products. Biotechnol Bioeng 2023;120:1189. DOI: https://doi.org/10.1002/bit.28346

Gillespie C, Wasalathanthri DP, Ritz DB, Zhou G, Davis KA, Wucherpfennig T, Hazelwood N. Systematic assessment of process analytical technologies for biologics. Biotechnol Bioeng 2022;119:423. DOI: https://doi.org/10.1002/bit.27990

Butler HJ, Ashton L, Bird B, Cinque G, Curtis K, Dorney J, Esmonde-White K, Fullwood NJ, Garden B, Martin-Hirsch PL, Walsh MJ, McAinsh MR, Stone N, Martin FL. Using Raman spectroscopy to characterize biological materials’. Nature Protocols 2016;11:664. DOI: https://doi.org/10.1038/nprot.2016.036

Silge A, Weber K, Cialla-May D, Müller-Bötticher L, Fischer D, Popp J. Trends in pharmaceutical analysis and quality control by modern Raman spectroscopic techniques. Trends in Analytical Chemistry 2022;153:116623. DOI: https://doi.org/10.1016/j.trac.2022.116623

Walla B, Bischoff D, Viramontes IC, Figueredo SM, Weuster-Botz D, Recent advances in the monitoring of protein crystallization processes in downstream processing. Crystals 2023;13:773. DOI: https://doi.org/10.3390/cryst13050773

Talicska CN, O’Connell EC, Ward HW, Diaz AR, Harding MA, Foley DA, Connolly D, Girard KP, Ljubicic T. Process analytical technology (PAT): applications to flow processes for active pharmaceutical ingredient (API) development. React Chem Eng 2022;7:1419. DOI: https://doi.org/10.1039/D2RE00004K

Miyai Y, Formosa A, Armstrong C, Marquardt B, Rogers L, Roper T. PAT Implementation on a mobile continuous pharmaceutical manufacturing system: real-time process monitoring with in-line FTIR and Raman Spectroscopy. Org Process Res Dev 2021;25:2707. DOI: https://doi.org/10.1021/acs.oprd.1c00299