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dc.contributor.authorBuckley, Kevin
dc.contributor.authorRyder, Alan G.
dc.date.accessioned2018-02-28T14:08:24Z
dc.date.available2018-02-28T14:08:24Z
dc.date.issued2017-05-23
dc.identifier.citationBuckley, Kevin, & Ryder, Alan G. (2017). Applications of Raman Spectroscopy in Biopharmaceutical Manufacturing: A Short Review. Applied Spectroscopy, 71(6), 1085-1116. doi: 10.1177/0003702817703270en_IE
dc.identifier.issn1943-3530
dc.identifier.urihttp://hdl.handle.net/10379/7177
dc.description.abstractThe production of active pharmaceutical ingredients (APIs) is currently undergoing its biggest transformation in a century. The changes are based on the rapid and dramatic introduction of protein- and macromolecule-based drugs (collectively known as biopharmaceuticals) and can be traced back to the huge investment in biomedical science (in particular in genomics and proteomics) that has been ongoing since the 1970s. Biopharmaceuticals (or biologics) are manufactured using biological-expression systems (such as mammalian, bacterial, insect cells, etc.) and have spawned a large (>E35 billion sales annually in Europe) and growing biopharmaceutical industry (BioPharma). The structural and chemical complexity of biologics, combined with the intricacy of cell-based manufacturing, imposes a huge analytical burden to correctly characterize and quantify both processes (upstream) and products (downstream). In small molecule manufacturing, advances in analytical and computational methods have been extensively exploited to generate process analytical technologies (PAT) that are now used for routine process control, leading to more efficient processes and safer medicines. In the analytical domain, biologic manufacturing is considerably behind and there is both a huge scope and need to produce relevant PAT tools with which to better control processes, and better characterize product macromolecules. Raman spectroscopy, a vibrational spectroscopy with a number of useful properties (nondestructive, non-contact, robustness) has significant potential advantages in BioPharma. Key among them are intrinsically high molecular specificity, the ability to measure in water, the requirement for minimal (or no) sample pre-treatment, the flexibility of sampling configurations, and suitability for automation. Here, we review and discuss a representative selection of the more important Raman applications in BioPharma (with particular emphasis on mammalian cell culture). The review shows that the properties of Raman have been successfully exploited to deliver unique and useful analytical solutions, particularly for online process monitoring. However, it also shows that its inherent susceptibility to fluorescence interference and the weakness of the Raman effect mean that it can never be a panacea. In particular, Raman-based methods are intrinsically limited by the chemical complexity and wide analyte-concentration-profiles of cell culture media/bioprocessing broths which limit their use for quantitative analysis. Nevertheless, with appropriate foreknowledge of these limitations and good experimental design, robust analytical methods can be produced. In addition, new technological developments such as time-resolved detectors, advanced lasers, and plasmonics offer potential of new Raman-based methods to resolve existing limitations and/or provide new analytical insights.en_IE
dc.description.sponsorshipKB is a Government of Ireland Postdoctoral Fellow and would like to thank the Irish Research Council for their support (Grant no.: GOIPD/2015/88). Some support for KB from the Synthesis and Solid State Pharmaceutical Centre, funded by Science Foundation Ireland and industry partners (Grant no.: 12/RC/2275) is also acknowledged.en_IE
dc.formatapplication/pdfen_IE
dc.language.isoenen_IE
dc.publisherSage Publicationsen_IE
dc.relation.ispartofApplied Spectroscopyen
dc.subjectRaman spectroscopyen_IE
dc.subjectBiopharmaceutical manufacturingen_IE
dc.subjectCell culture mediaen_IE
dc.subjectChemometricsen_IE
dc.subjectOnline monitoringen_IE
dc.subjectProteinsen_IE
dc.titleApplications of raman spectroscopy in biopharmaceutical manufacturing: A short reviewen_IE
dc.typeArticleen_IE
dc.date.updated2017-05-26T15:08:01Z
dc.identifier.doi10.1177/0003702817703270
dc.local.publishedsourcehttps://doi.org/10.1177/0003702817703270en_IE
dc.description.peer-reviewedpeer-reviewed
dc.contributor.funderIrish Research Councilen_IE
dc.contributor.funderScience Foundation Irelanden_IE
dc.internal.rssid12650405
dc.local.contactAlan Ryder, School Of Chemistry, Room 213, Arts/Science Building, Nui Galway. 2943 Email: alan.ryder@nuigalway.ie
dc.local.copyrightcheckedNo Article is Open access on the Applied Spectroscopy website.
dc.local.versionPUBLISHED
dcterms.projectinfo:eu-repo/grantAgreement/SFI/NSF/SFI Graduate Research Opportunities Worldwide (GROW) Programme/12/RC/2275s3/IE/Synthesis and Solid State Pharmaceutical Centre (SSPC) GROW Supplement/
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