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Near-Infrared Spectroscopy as a Process Analytical Technology in the Biotech Industry. Presented to the Advisory Committee for Pharmaceutical Science Food and Drug Administration April 13, 2004 By Robert A. Mattes Foss. Near-infrared Spectroscopy Spectral Region. Near-Infrared. UV.

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Near-Infrared Spectroscopy as a Process Analytical Technology in the Biotech Industry


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    1. Near-Infrared Spectroscopy as a Process Analytical Technologyin the Biotech Industry Presented to the Advisory Committee for Pharmaceutical Science Food and Drug Administration April 13, 2004 By Robert A. Mattes Foss

    2. Near-infrared SpectroscopySpectral Region Near-Infrared UV Visible Mid-Infrared 200 400 700 2500 25,000 nm 50,000 25,000 14,285 4,000 400cm-1 Elemental Constituent Assay Functional Group Analysis Appearance

    3. Pharmaceutical ManufacturingNIR Applications Incoming Raw Materials Material Dispensary Lyophilization In-Process: Fermentation and Cell Culture Monitoring Warehouse Shipping

    4. Control Capabilities with NIR/PAT Control feedback On-line monitoring of critical process parameters Process control Process Improvement Closed loop control (Real-Time) BioPharm Process Reactor Temperature Sparging NIR monitoring Nutrient levels Moisture level Melt detection In Lyo Process output Raw Materials

    5. Industrial Organisms StudiedNIR Bioprocess Method Development

    6. NIR Spectral Acquisition and Analysis for Bioprocesses

    7. NIR Spectral Analysis Analytical Region for Key analytes t=0, t=27 hr Second-derivative of Log(1/T) Glycerol, acetate, biomass

    8. NIR Bioprocess Trends Chart

    9. NIR Bioprocess Analytical Results

    10. Near IR applied to Mammalian Cell Cultivation • Industrial CHO-K1 cell line • In-situ NIR using transflectance measurements (1.2 mm pathlength) • 2 Liter bioreactor run for 168 –240 hours, including a temperature change • Developed NIR calibrations for: • Glucose • Glutamine • Lactate • Ammonia Ref: SA Arnold, J Crowley, N Woods, LM Harvey, and B McNeil, Biotech and Bioeng 84(1), 13-19 (2003).

    11. Direct In-Line Analysis in Mammalian Cell Cultivation • Direct fermenter interface • Standard Ingold ports • Optimized for specific analytes/matrices • Dedicated analysis on defined media • Simultaneous results <1 minute • Monitoring and closed-loop control • Pilot plant/scale-up operations and manufacturing Direct Sample Interface

    12. Summary of NIR Results for CHO cell work Multifactor PLS calibrations developed on second derivative spectra with 217 samples

    13. Enlarged View of Second Derivative Spectra Used for Analysis of Lyophilized Product

    14. NIR Benefits for the PAT Biotech Initiative • NIR offers the advantage of real-time analysis in biotech sterile environments and the possibility of closed-loop feed back process control • Benefits in process … • Non-invasive analysis • Processoptimization • Waste reduction • Better understanding of processes and • Safer, improved, more consistent product