Raman spectroscopy as a process analytical technology for pharmaceutical manufacturing and bioprocessing
| Autor: | Karen A. Esmonde-White, Ian R. Lewis, Bruno Lenain, Maryann Cuellar, Carsten Uerpmann |
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| Rok vydání: | 2016 |
| Předmět: |
Engineering
Recombinant protein Emerging technologies Process analytical technology 02 engineering and technology Review Spectrum Analysis Raman 01 natural sciences Biochemistry Quality by Design Analytical Chemistry symbols.namesake Technology Pharmaceutical Bioprocess Process engineering Scope (project management) business.industry Bioprocessing 010401 analytical chemistry 021001 nanoscience & nanotechnology Statistical process control 0104 chemical sciences Raman spectroscopy Pharmaceutical symbols Pharmaceutical manufacturing Cell culture 0210 nano-technology business Biotechnology |
| Zdroj: | Analytical and Bioanalytical Chemistry |
| ISSN: | 1618-2650 |
| Popis: | Adoption of Quality by Design (QbD) principles, regulatory support of QbD, process analytical technology (PAT), and continuous manufacturing are major factors effecting new approaches to pharmaceutical manufacturing and bioprocessing. In this review, we highlight new technology developments, data analysis models, and applications of Raman spectroscopy, which have expanded the scope of Raman spectroscopy as a process analytical technology. Emerging technologies such as transmission and enhanced reflection Raman, and new approaches to using available technologies, expand the scope of Raman spectroscopy in pharmaceutical manufacturing, and now Raman spectroscopy is successfully integrated into real-time release testing, continuous manufacturing, and statistical process control. Since the last major review of Raman as a pharmaceutical PAT in 2010, many new Raman applications in bioprocessing have emerged. Exciting reports of in situ Raman spectroscopy in bioprocesses complement a growing scientific field of biological and biomedical Raman spectroscopy. Raman spectroscopy has made a positive impact as a process analytical and control tool for pharmaceutical manufacturing and bioprocessing, with demonstrated scientific and financial benefits throughout a product’s lifecycle. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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