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

Presented to the

Advisory Committee for Pharmaceutical Science

Food and Drug Administration

April 13, 2004

By

Robert A. Mattes

Foss


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Near-infrared Spectroscopy TechnologySpectral 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


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Pharmaceutical Manufacturing TechnologyNIR Applications

Incoming Raw Materials

Material Dispensary

Lyophilization

In-Process: Fermentation and Cell Culture Monitoring

Warehouse Shipping


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Control Capabilities with NIR/PAT Technology

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


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Industrial Organisms Studied TechnologyNIR Bioprocess Method Development



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NIR Spectral Analysis Technology Analytical Region for Key analytes

t=0, t=27 hr

Second-derivative of Log(1/T)

Glycerol, acetate, biomass




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Near IR applied to Mammalian Cell Cultivation Technology

  • 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).


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Direct In-Line Analysis in Mammalian Cell Cultivation Technology

  • 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


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Summary of NIR Results for CHO cell work Technology

Multifactor PLS calibrations developed on second derivative spectra with 217 samples


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Enlarged View of Second Derivative Spectra Technology Used for Analysis of Lyophilized Product


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NIR Benefits for the TechnologyPAT 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


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