title: Raman spectroscopy as a process analytical technology for pharmaceutical manufacturing and bioprocessing.
abstract: 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.
authors.affiliation: Kaiser Optical System, Inc, 371 Parkland Plaza, Ann Arbor, MI, 48103, USA. Karen.Esmonde-White@kosi.endress.com.|University of Michigan Medical School, Ann Arbor, MI, 48109-5624, USA. Karen.Esmonde-White@kosi.endress.com.
authors.forename: Karen A
authors.initials: KA
authors.lastname: Esmonde-White
authors.affiliation: Kaiser Optical System, Inc, 371 Parkland Plaza, Ann Arbor, MI, 48103, USA.
authors.forename: Maryann
authors.initials: M
authors.lastname: Cuellar
authors.affiliation: Kaiser Optical Systems SARL, 5 Allée Moulin Berger, 69130, Ecully, France.
authors.forename: Carsten
authors.initials: C
authors.lastname: Uerpmann
authors.affiliation: Kaiser Optical Systems SARL, 5 Allée Moulin Berger, 69130, Ecully, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Lenain
authors.affiliation: Kaiser Optical System, Inc, 371 Parkland Plaza, Ann Arbor, MI, 48103, USA.
authors.forename: Ian R
authors.initials: IR
authors.lastname: Lewis
mesh_terms: D001709:Biotechnology / Q000295:instrumentation / Q000379:methods*; D013059:Spectrum Analysis, Raman; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000379:methods*
keywords: Bioprocessing; Cell culture; Pharmaceutical; Process analytical technology; Raman spectroscopy; Recombinant protein