Institut für Verfahrenstechnik, Umwelttechnik und Techn. Biowissenschaften
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Developing a generic method to characterize a recombinant protein production bio-process in dynamic process conditions

 

Wir bitten um Verständnis, dass die Informationen über dieses Projekt derzeit nur in englischer Sprache verfügbar sind.

 

Motivation

In an effort to understand how the protein is produced in large scale with the required quality and efficacy, a number of studies on the effects of process parameters on recombinant protein production have been carried out. Key process parameters are temperature, dissolved oxygen and pH, as well as substrate excess, growth rates and metabolite formation.
As an extension of the common static approach, the goal of the project is the efficient quantification of effects of Critical Process Parameters (CPP) on Critical Quality Attributes (CQA) by highly dynamic process conditions. Multivariate effects will be investigated as well as oscillatory effects of single parameters. With this, we are ultimately striving to propose a general method for process understanding applicable to recombinant protein production aiming establishing an analytical set up to characterize the system being studied. The method would be capable of introducing suitable feed profiles beyond fed batch and optimum process conditions that meet desired CQAs.
Hence, this project is proposing new methodologies to allow an efficient process development along Quality by Design (QbD) principles.

Publications:

  1. M.H. Jazini, Ch. Herwig, Effect of post-induction substrate oscillation on recombinant alkaline phosphatase production expressed in Escherichia coli, Journal of Bioscience and Bioengineering, VOL. 112 No. 6, 606–610, 2011.

Talks:

  1. M.H. Jazini, Ch. Herwig, Effects of substrate-related stress on recombinant protein production, 5th International Congress on pharmaceutical engineering, September 2011, Graz, Austria.
  2. M.H. Jazini, Ch. Herwig, Temperature and substrate‐related stresses enhance recombinant protein production, 2nd Bioproscale symposium, March 2012, Berlin, Germany.

 

Kontakt:

Mohammadhadi Jazini

Univ.Prof. Dipl.-Ing. Dr.techn. Christoph Herwig