Advances in a range of developmental and analytical tools drive the pharmaceutical industry toward Bioprocessing 4.0.
“Adoption of Quality-by-Design (QBD) and Process Analytical Technology (PAT) frameworks has helped the biopharmaceutical field to realize consistent product quality, process intensification, and real-time control,” according to Karen Esmonde-White, PhD, and her colleagues from Kaiser Optical Systems, an Endress+Hauser company in Ann Arbor, MI. “As part of a PAT strategy, Raman spectroscopy offers many benefits and is used successfully in biopharmaceutical manufacturing from single-cell research to cGMP upstream process control in a cGMP environment.”
When asked about this work, Esmonde-White said, “I’m really excited to see the most recent literature showing us that Raman spectroscopy is now a first-choice PAT in upstream bioprocessing.” She added, “Nearly 10 years after the first report of industrial use of Raman in cell-culture monitoring, we’ve seen rapid acceptance and growth in using Raman spectroscopy in bioprocessing.”
That acceptance impacts a range of bioprocessing-related applications, including clinical manufacturing, real-time control of multiple parameters, and lab-to-GMP scalability. “The growth in applications also goes hand-in-hand with the emergence of enabling Raman technologies in probes, embedded controllers, single-use bioreactors, and compatibility with micro-bioreactors,” Esmonde-White explained. “These new applications and Raman technologies certainly support Industry 4.0 and IIoT—industrial Internet of things—initiatives such as digital twins, smart sensors, and automated model optimization.”
Making use of these technologies in commercial bioprocessing, though, takes some work. “Using a PAT in some applications is not as easy as just turning on the instrument and pressing a button,” Esmonde-White noted. “Raman spectroscopy is a powerful technique because it can measure multiple parameters, but it can be challenging to maximize the amount of process knowledge from the Raman data or explore new lab-to-process applications.”
Esmonde-White suggested talking with a vendor’s application scientists or product managers. “Another way we can get more out of Raman spectroscopy is to become more involved with the bioprocessing community,” she said. “The industry-wide collaborative groups, like NIIMBL or BioPhorum, provide a knowledgeable network and perspectives on new approaches to manufacturing.”
Despite the increasing traction of using Raman spectroscopy in bioprocessing, much more could lie ahead. Esmonde-White, noted: “As exciting as these past 10 years have been, I’m enthusiastic about the next 10 years as Raman expands into downstream monitoring, perfusion approaches to manufacturing, and cell or gene therapies.”