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

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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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slide1

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

near infrared spectroscopy spectral region
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

pharmaceutical manufacturing nir applications
Pharmaceutical ManufacturingNIR Applications

Incoming Raw Materials

Material Dispensary

Lyophilization

In-Process: Fermentation and Cell Culture Monitoring

Warehouse Shipping

control capabilities with nir pat
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

nir spectral analysis analytical region for key analytes
NIR Spectral Analysis Analytical Region for Key analytes

t=0, t=27 hr

Second-derivative of Log(1/T)

Glycerol, acetate, biomass

near ir applied to mammalian cell cultivation
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).

direct in line analysis in mammalian cell cultivation
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

summary of nir results for cho cell work
Summary of NIR Results for CHO cell work

Multifactor PLS calibrations developed on second derivative spectra with 217 samples

slide14

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
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