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The FDA’s Quality by Design (QbD) initiative brought a paradigm shift to pharmaceutical manufacturing and leading manufacturers have realised improved processes after adopting QbD. Raman spectroscopy is an established Process Analytical Technology (PAT), enabling QbD and continuous approaches to pharmaceutical manufacturing.1
Raman spectroscopy is an analysis technique that provides a “molecular fingerprint” of the sample, enabling analysis of chemical composition and molecular structure without sample preparation. As a measurement technique, Raman imparts many benefits in applications from laboratory discoveries to feedback-control in manufacturing.
Bioprocesses require automated process control to make quality products consistently and efficiently...
Kaiser announces that their analytical solutions for in situ bioprocess monitoring and control has been recognised with the 2017 Aspen Award for the Advancement of Upstream Bioprocessing...
When you work with Kaiser, you have the entire Kaiser team on your side...
Continuous manufacturing approaches have been gaining interest in the pharmaceutical industry. They allow shorter production times, enable novel reaction pathways, increase assurances of product quality and help to realise cost savings...
Kaiser provides optimised Raman solutions for research, analytical and process markets. Find out why leading companies around the world trust Kaiser in Raman spectroscopy to improve process efficiency, ensure product quality and achieve application success.
Esmonde-White, K. A., Cuellar, M., Uerpmann, C., Lenain, B., & Lewis, I. R. Raman spectroscopy as a process analytical technology for pharmaceutical manufacturing and bioprocessing. Anal. Bioanal. Chem. 409, 637–649 (2016). Strachan, C. J., Rades, T., Gordon, K. C. , & Rantanen, J. Raman spectroscopy for quantitative analysis of pharmaceutical…
Regulatory guidelines, from the 2004 U.S. FDA PAT framework to ICH Q8, Q9, Q10 and Q11 documents, have brought a shift to pharmaceutical processes and manufacturing...
Production of protein therapeutics by mammalian cells is the most widely used bioprocess because of its ability to properly produce and fold a recombinant protein...
Pharmaceutical tablets are coated for a variety of reasons, such as to enhance the appearance, taste, chemical stability, or swallowability of the tablet or to create a particular release profile for the active pharmaceutical ingredient (API)...
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...
Raman spectroscopy is an analysis technique that provides a “molecular fingerprint” of the sample, enabling analysis of chemical composition and molecular structure without sample preparation..
The work presented here investigates the development and application of new bioprocess analytics in accordance with the aims of QbD...
Production of protein therapeutics by mammalian cells is the most widely used bioprocess because of its ability to properly produce and fold a recombinant protein...
