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Bioprocess Separations & Biologics Formulation Development

Downstream Processing in Red and White Biotechnology

The development of industrial scale bioprocesses has come into high scientific and industrial interest over the last decades. Especially in the red and white biotechnology process costs are often dominated by up to 80 % by the downstream processing.

Although innovative concepts for their purification, such as the aqueous two phase extraction exist; implementation of these unit operations as well as industrial implementation suffers from the leak of appropriate process understanding.

 Conventional process development/design approaches fail, due to the fact that knowledge on the complex interactions between the molecules in the fermentation broth is limited.

This task can be solved by accessing molecular interactions of the components considered, as well as physical properties based effects introduced to the system by the nature of the (bio)-system.


Biologics Formulation Development

Whilst identification and characterization of therapeutic proteins (e.g. monoclonal antibodies, mabs) in terms of clinical tests clearly fall into the medical disciplines, formulation and processing more and more require an interdisciplinary approach including the core engineering disciplines such as thermodynamics

With more and more complex pharmaceuticals being developed the need for a deeper understanding of stabilizing mechanisms, design tools, and especially thermodynamic models to estimate appropriate formulations (choice of excipients / surfactants) for the respective targeting (intravenous or subcutaneous injection) is unquestionable. In order to serve for medical applications, the dose of the biopharmaceutical drug should amount to 150 - 200 mg per injection. In order to comply with standard equipment this leads to the requirement of a target concentration of 150 -200 mg/mL with higher concentrations up to 300 mg/mL being desirable.


Bio-Thermodynamics offers several tools to account for physical and thermodynamic properties in complex mixtures and thus can serve as an innovative approach for the characterization of these systems.

The research carried out at the bioprocess separations group hereby focuses on :

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Current Research Projects in the group:


 

Applied catastrophic phase inversion

Abstract:

The potential of whole-cell biocatalysis as an efficient and green alternative to common chemical synthesis routes rises increasingly. Using a biphasic reaction system provides high stereo selectivity as well as high product titers due to the presence of an organic phase serving as substrate reservoir and product sink. The challenge for an industrial implementation of biphasic whole-cell biocatalysis is the formation of stable emulsions that cannot be separated by common unit operations. In contrast using the phenomenon of catastrophic phase inversion (CPI) phase separation is easily achieved by a sudden switch of emulsion type caused by addition of dispersed phase.

Weiterlesen: Lisa Vahle

 

Increasing Protein Solubility for High-Concentration Protein Formulations using Advanced Additives

Abstract:

The application of monoclonal antibodies and proteins is an emerging field in biotechnology due to their high specificity with antigens [1]. However, most of the proteins have a poor solubility in water and therefore their application is mostly limited to intravenous administration. In the course of this work, suitable additives shall be identified that increase the protein concentration up to 150 to 200 mg mL-1 to enable subcutaneous administration of these formulations with higher patient compliance.

Weiterlesen: Miko Schleinitz

 

Completed Research Projects in the group:


 

Reactive extraction of hydrophilic products of biocatalytic origin

 

Predicting phase behavior of aqueous-protein solutions

 

Thermodynamics based approaches for process optimization in biphasic whole-cell biocatalysis

 

Crystallization of pharmaceutical proteins – Predicting protein solubility

 

Modeling bio-relevant aqueous two-phase systems

 



Nebeninhalt

Kontakt

Foto von PD Dr.-Ing. Christoph Brandenbusch

PD Dr.-Ing. Christoph Brandenbusch

Adresse:

TU Dortmund
Fakultät Bio- und Chemieingenieurwesen
Emil-Figge-Str. 70
44227 Dortmund

Raum G2-513

 

 

DFG

 

 

CLIB

 

 

InPrompt