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Value and Applicability of Spectroscopy in Biopharmaceuticals and Product Development

Value and Applicability of Spectroscopy in Biopharmaceuticals and Product Development  content piece image
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A new collaborative study from RedshiftBio (Burlington, MA) and a Major Pharmaceutical Company published in the Journal of Pharmaceutical Sciences provides compelling evidence of the benefits of the award winning AQS3™pro, a Microfluidic Modulation Spectroscopy platform from RedShift BioAnalytics, Inc., for the biopharmaceutical industry. The paper illustrates how the instrument’s performance exceeds conventional FTIR when characterizing the secondary structure of monoclonal antibodies (mAbs), a common class of biotherapeutics. Secondary structure is an important product quality attribute of all proteins that is measured throughout the product development life cycle. The authors conclude that the “method can be widely applied in characterization and comparability/biosimilarity studies for biopharmaceutical process and product development”.

Infrared (IR) spectroscopy has long been recognized as a powerful tool for determining protein secondary structure and monitoring potential structural changes in the overall higher order structure of biotherapeutics. These analyses inform upstream (cell culture) and downstream (purification) process development conditions, as well as being critical in assessing product quality via protein characterization, comparability, biosimilarity and stability studies.

The new paper demonstrates that Microfluidic Modulation Spectroscopy exhibits higher sensitivity and repeatability for low concentration therapeutic mAb samples relative to conventional FTIR. The AQS3pro also provides automated operation and “superior robustness with simplified data analysis”, increasing the role of the instrument in the determination of mAb secondary structure. These features directly address some of the widely recognized limitations of conventional FTIR, substantially expanding the accessibility and utility of secondary structure measurements.

“Users of the AQS3pro have long known that this technology addresses shortcomings in traditional biophysical characterization techniques”, comments Julien Bradley, CEO of RedShiftBio. “We are excited to see data published from key industry leaders, confirming the unique role Microfluidic Modulation Spectroscopy has in the biophysical characterization toolkit.”

Reference: Liu LL, Wang L, Zonderman J, et al. Automated, High-Throughput Infrared Spectroscopy for Secondary Structure Analysis of Protein Biopharmaceuticals. J.Pharm.Sci. 2020. doi:10.1016/j.xphs.2020.07.030

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