Kaiser hosts a series of complimentary webinar presentations which demonstrate Raman Spectroscopy-based solutions. Hear from real customers and their success stories using Kaiser Raman analyzers and instruments. Examples of Research Raman, Analytical Raman, Process Raman, In Situ Raman, Industrial Raman, Remote Raman, and Raman Imaging and Microscopy are available during these sessions. We invite you to register for an upcoming webinar of interest, or view previous archives. Kaiser Webinar Archives are available in the sidebar -- see what you've been missing!
Real Customers - Their Applications, Raman Solutions
Raman Spectroscopy for Cell Culture Process Monitoring and Multi-Feed Control
The FDA’s process analytical technology (PAT) initiative encourages pharmaceutical manufacturers to use innovative analytical tools to improve the understanding and control of their manufacturing processes. The use of Raman spectroscopy as an in-line PAT tool can generate real-time predictions of bioreactor process information, such as glucose and lactate concentrations. Traditionally, this information was acquired sporadically through offline measurements. Raman can not only enable monitoring of media composition, but also be used to implement nutrient control and specific feeding regimens for cell culture processes through carefully designed feedback algorithms. Such control simplifies the execution of unit operations and can also lead to improvements in cell metabolism, process understanding, drug substance yield, and product quality. Naturally, to reap the benefits of PAT as a part of a bioprocess manufacturing strategy, it is imperative to tackle various method development challenges and to demonstrate returns from a process performance perspective.
GlaxoSmithKline has embedded Raman spectroscopy as a key PAT tool in R&D for media composition prediction and feeding regimen control and is currently transferring Raman to clinical and commercial manufacturing sites. Our model development strategy is based on utilizing spectroscopic datasets collected with wide process variations, spiking, the use of chemometric algorithms to determine spectral regions of interest, and testing the feasibility of global and local calibrations. In a novel study, Raman spectroscopy was used to implement simultaneous feedback control of glucose and lactic acid in a 3L CHO bioprocess producing a monoclonal antibody (mAb). Lactic acid feeding to a setpoint of 2 g/L led to a substantially lower level of ammonium and CO2 accumulation. Additionally, from a quality standpoint, higher galactosylation of the mAb was observed with lactic acid control. Therefore, this study shows evidence that the implementation of Raman as a process control tool provides the capability to tune product quality by impacting cell metabolism. In conclusion, this work demonstrates the power of Raman spectroscopy for not only real-time process monitoring, but also implementing feedback control for product quality tuning.
AIR DATE: September 24, 2019
Name: Dr. Tom Eyster
Name: Dr. Sameer Talwar
Title: Senior Chemometrician