WP5: Spectrometry and chemometry

The purpose of this WP is to investigate Raman, NIR, MIR and 2D fluorescence spectroscopy for the detection and quantitation of varying parameters consisting of, but not limited to, metabolites, amino acids, (viable) cell concentration, titre, CQA attributes, viability and bioburden in various cell culture processes (fed-batch and continuous) in order to provide validated tools for monitoring and adjusting (control-loop) the processes in (near) real-time.

These tools can be applicable for development purposes as well as for the implementation in GMP processes. Knowledge and experience from academic and industrial partners will be applied during the development as well as close interaction with the following work packages:

• WP 2: High Through put micro-bioreactors (transfer from small scale to production scale)
• WP 4: Optical on-line sensors (for supplementary information)
• WP 7: Sampling preparation (e.g. cell free sampling for at line analytics)
• WP 8: Models Ð data driven, mechanistic, control

Objectives

• Identify spectroscopic direct and indirect measurable process variables
• Determine spectral pre-processing procedures
• Determine meaningful wavelengths (combinations) for modelling
• Develop chemometric models methodology
• Module for optimal design of experiment WP2
• Determine the transferability of chemometric models (MBR to STR)
• Define validation procedures of chemometric models for life cycle management
• Contribution of chemometric models for closed-loop control
• Select spectrophotometric method (Raman, NIR, MIR, 2D fluorescence, or wavelength combinations) to be used

Participants

Lead: University Hoheinheim
Co-lead: Sanofi

Participants:
UMons
KTH-Chotteau
Ipratech
Bayer
Rentschler
Synthon
GSK