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Karlsruhe Institute of Technology

Institute of Engineering in Life Sciences

Section IV: Biomolecular Separation Engineering

Fritz-Haber-Weg 2

76131 Karlsruhe

Tel: +49 721 608 42557
Fax: +49 721 608 46240

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Bioprinting and Lab Prototyping

Printing

For development and optimization of process steps as well as whole processes, it is important to minimize the time for implementation of new ideas. At MAB, rapid prototyping techniques are used, which allow a fast workflow from ideas to ready-for-use prototypes. We rely on multiple 3D printers (FDM and SLA) for rapid prototyping. The devices open up new ways in high throughput process development.

For biological applications, a 3D Bioscaffolder is employed which allows printing of high viscous materials and biomolecules on technical substrates.

 

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Characterization of Protein Solutions

Protein Characterization

The accurate characterization of protein solutions is indispensable for an optimal process design and formulation development. Here, the solubility of the target molecules and the long term stability of biopharmaceuticals are regarded as a bottleneck in the biopharmaceutical development. Therefore, our scientific group focuses on the analysis off protein-protein interactions, the resulting protein phase behavior, the predictability of protein phase behavior and its manipulation. We study model proteins, pharmaceutical relevant molecules like monoclonal antibodies, different classes of enzymes as well as virus like particles under ideal dilute and highly concentrated conditions.

 

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Experimental Process Development

 HTPD

The biopharmaceutical production industry is based on a vast number of complex process setups which all rely high experimental effort. A high amount of process knowledge and optimization helps meeting the requirements stated by the authorities such as the FDA, EMA, etc. High-throughput methodologies have become a central tool in experimental process development. Using high-throughput systems (HTS) including automated robotic platforms, development times and manufacturing costs can be reduced to a minimum due to miniaturization, parallelization and automation of experiments. In our institute HTS methods are used in cell cultivation and product formation studies (upstream processing) as well as downstream application (protein purification). Robotic screenings in high-throughput format include precipitation screenings, characterization experiments for aqueous two-phase systems, as well as chromatography in batch and column mode.

 

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Model-Based Process Development

MD

Modeling of biomolecular systems offers the possibility to gain a better understanding of protein behavior on molecular and macroscopic levels. Our research is focused on two different approaches. The molecular dynamics simulations (MD) consider protein molecules in their atomic surrounding and enable the deduction of a proteins macroscopic behavior. The mechanistic modeling of chromatography systems considers the purification process on a macroscopic level. Mass transfer and binding effects are described with differential equations. In combination with objective functions, an optimal process design can be achieved. 

 

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Process Control

Process Control

During production of biopharmaceuticals efficient process monitoring and control is central for an economic and reliable process. MAB is working on innovative new technologies for monitoring purification processes. A focus is set towards monitoring processes by spectroscopic methods in conjunction with chemometrics.

 

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