eBook: FTIR/NIR/Raman in (Bio) Pharmaceutical Analysis

Vibrational Spectroscopy (IR and Raman) has been a well established technique in small molecule manufacturing for quality control and PAT applications. R&D, formulation and manufacturing of biologics (large molecule) is much more complex. Biologics are structurally and chemically complex and there is a huge analytical burden to correctly characterize them and quantify both processes and products. Thermo Fisher Scientific's vibrational spectroscopy (FTIR, FTNIR, Raman) product portfolio includes benchtop analyzers, process analyzers, IR microscope and imaging systems and Raman microscope and imaging systems. These tools enable raw material verification in upstream processing to downstream foreign particulate testing. Here we present expert interviews on the applications of vibrational spectroscopy in biologics manufacturing.

• Protein secondary structure
• Foreign particulate identification in biopharmaceuticals
• Enabling real-time release of final products in manufacturing of biologics
• Cell media dissolution by NIR: Controlling biopharma variability