Automated IR-Spectroscopy for Analysis of Protein Biopharmaceuticals

Higher-order structure is an important critical quality attribute that correlates structure-function characteristics with safety and efficacy for protein biotherapeutics. Infrared (IR) spectroscopy has long been recognized as a powerful biophysical tool for determining protein secondary structure and monitoring dynamic structural changes. Structural analysis helps establish process and product knowledge, inform the impact of upstream (cell culture) and downstream (purification) process conditions, identify stable formulations, monitor product stability, and assess product comparability when process improvements are implemented. Within the market of biosimilars, the characterization of secondary structure is paramount in determining similarity with established, commercially available molecules.  

In this GEN webinar, Dr. Lucy Liu of Pfizer provides an overview of the novel Microfluidic Modulation Spectroscopy (MMS) or Microfluidic Modulation IR-Spectroscopy (MM-IR) technique, an automated mid-IR spectroscopic tool for the characterization of protein secondary structure. The data demonstrate that MMS/MM-IR secondary structure analysis of therapeutic monoclonal antibodies (mAb) provides comparable structural information relative to conventional Fourier Transform IR (FTIR) analysis and, more importantly, shows that MMS/MM-IR exhibits higher sensitivity and repeatability for low concentration samples compared to FTIR, as an automated platform with superior robustness. MMS/MM-IR is built upon real-time background subtraction and adds simplified data analysis, automation, and robustness.  These core benefits make the platform indispensable for the determination of mAb secondary structure and support the conclusion that MMS/MM-IR can be widely applied in characterization and comparability studies across the biotherapeutic development pipeline.

A live Q&A session followed the presentations, offering a chance to pose questions to our expert panelists.

Webinar produced with support from: