Near-Infrared Spectroscopy as a Process Analytical Technology
1 / 14

Near-infrared Spectroscopy - PowerPoint PPT Presentation

  • Updated On :

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.

I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
Download Presentation

PowerPoint Slideshow about 'Near-infrared Spectroscopy ' - sherlock_clovis

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.

- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
Slide1 l.jpg

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


Robert A. Mattes


Near infrared spectroscopy spectral region l.jpg
Near-infrared Spectroscopy TechnologySpectral Region









25,000 nm







Constituent Assay

Functional Group Analysis


Pharmaceutical manufacturing nir applications l.jpg
Pharmaceutical Manufacturing TechnologyNIR Applications

Incoming Raw Materials

Material Dispensary


In-Process: Fermentation and Cell Culture Monitoring

Warehouse Shipping

Control capabilities with nir pat l.jpg
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



NIR monitoring

Nutrient levels

Moisture level

Melt detection

In Lyo

Process output

Raw Materials

Industrial organisms studied nir bioprocess method development l.jpg
Industrial Organisms Studied TechnologyNIR Bioprocess Method Development

Nir spectral analysis analytical region for key analytes l.jpg
NIR Spectral Analysis Technology 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 l.jpg
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).

Direct in line analysis in mammalian cell cultivation l.jpg
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

Summary of nir results for cho cell work l.jpg
Summary of NIR Results for CHO cell work Technology

Multifactor PLS calibrations developed on second derivative spectra with 217 samples

Enlarged view of second derivative spectra used for analysis of lyophilized product l.jpg
Enlarged View of Second Derivative Spectra Technology Used for Analysis of Lyophilized Product

Slide14 l.jpg

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