BioPharm International - July 2021

BioPharm - July 2021 - Biopharmaceutical Analysis

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Page 31 of 38 July 2021 BioPharm International eBook 31 Microfluidic Modulation Spectroscopy is a recent innovation in infrared spectroscopy techniques that improves elucidation of secondary protein structure. O ver the past two decades, the biopharmaceu- tical industry, along with the associated reg- ulatory authorities and analytical instrument suppliers, have progressed toward clearer identification of the attributes that are crit- ical for ensuring the quality of biopharmaceuticals and how to measure them efficiently. Biotherapeutic proteins are com- plex, labile molecules that present considerable formulation and manufacturing challenges. There are aspects of these molecules' behavior that still require much learning, such as the mechanisms that underpin aggregation. The need to understand and predict this behavior drives a requirement for new informational insights. However, the need to know more is balanced against requirements to do more with less— smaller sample volumes, fewer personnel/operator interac- tions, and shorter timeframes. When it comes to choosing instrumentation that can effi- ciently meet industrial needs, it is useful to have a clear under- standing of the fundamentals of an analytical technique and the information it can provide. This article puts the spotlight on infrared (IR) spectroscopy and recent innovations, including the introduction of Microfluidic Modulation Spectroscopy (MMS) as a technique that rewrites the benefits of IR for the industry. The aim of this article is to provide the information needed to assess how this technique can support established biophar- maceutical workflows by providing multiple analytical values including aggregation, quantitation, stability, similarity, and structure from one IR measurement. H O L LY LO M BA R D O * , HL o m b a rd o @ re d s hi f t bio.c o m, i s p ro d u c t manager, and MATTHEW MCGANN, is marketing manager; both are at RedShiftBio. * To whom all correspondence should be addressed. HOLLY LOMBARDO AND MATTHEW MCGANN Improving IR Spectroscopy as a Tool for Biopharmaceutical Analysis Robert Kneschke - Biopharmaceutical Analysis Protein Characterization

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