Purification of monoclonal antibodies using a novel continuous chromatography method

More efficient biopharmaceuticals production thanks to continuous downstream processing

© Fraunhofer IGB
Neue Pilotanlage zur kontinuierlichen Proteinreinigung der Firma LEWA im Technikum des Fraunhofer IGB.

As a part of the “Industry on Campus” project “Raw material and energy efficiency by process innovations”, Fraunhofer IGB researched optimized purification processes for pharmaceutical proteins.

The joint project wasis a public-private partnership funded by the state of Baden-Württemberg, in whose framework one of the partners from research and industry developed a pilot plant with which the participating companies and their customers can carry out tests under laboratory conditions.

Process innovation for pharmaceutical biotechnology

The research work of Fraunhofer IGB in the project aimed at intensified chromatographic purification processes of monoclonal antibodies and also other pharmaceutical products for the pharmaceutical industry. There is great need to optimize processes in this field since there is increasing cost pressure mainly from the expiration of patents and thus the competition from biosimilars and generica.

During the purification process of the monoclonal antibodies, in what is known as downstream processing, proteins are often separated from the fermentation broth by a capture step and purified to the desired purity level by further chromatography methods. Fraunhofer IGB has distinct expertise here and offers different variants of liquid chromatography.

Continuous chromatography saves time and materials

In the framework of the project, one of the industrial partners provided IGB with a new continuously operating laboratory plant desktop device to monitor the previous batch process developed by another project partner, in order to acquire data to improve the downstream processes with regard to product quality, time requirement and costs. These data were then used to put a pharma-suitable continuously operating pilot plant built by the same project partner into operation and optimize with trained staff in the IGB laboratory environment.

We demonstrated that the establishment of a continuous purification process offers the potential to increase productivity in the downstream field significantly without affecting the purity of the product. This also allows savings in time and process materials or raw material and the production becomes more efficient and cost-effective. In addition, researchers expect that scale-up of the production from the continuous chromatographic method will be simpler.

With completion of the “Industry on Campus“ project, since the end of 2016 a test plant in pilot scale is available for tests for industrial users of this technique in IGB.

Cooperation between Fraunhofer IGB and LEWA

In addition, LEWA provided the continuously operating laboratory plant desktop device (ChromaConCube). We are now looking for interested users from the pharmaceutical industry for test runs.

Are you interested in purifying your product in a continuous process?
Please contact us: we would be pleased to prepare a quote for you!

Joint project “Raw material and energy efficiency by process innovations”

Industrial production burdens the environment with emissions as well as by consuming resources such as energy and raw materials. With the latter , the possibility of substance conversion and finishing is becoming increasingly important. Such procedures can reduce the energy and resource consumption of raw material-related production fields with the ultimate aim of decoupling economic growth from resource consumption.

Process innovations that significantly increase the efficiency of production processes are thus in demand within process and material conversion industries. For this purpose, various research institutions and companies joined together in the “Kompetenznetz Verfahrenstechnik Pro3” association to seek ways to research efficiency-enhancing methods of substance conversion and finishing and bring them to application maturity in the framework of a the “Industry on Campus“ project funded by the state of Baden-Württemberg.

For “Industry on Campus“ projects, industrial companies and research institutions work together as a strategic partnership and are supported by the Baden-Württemberg Ministry of Science, Research and Art.

In addition to Fraunhofer IGB, the “Raw material and energy efficiency by process innovations” project includes several institutions of the Karlsruhe Institute of Technology KIT and the University of Stuttgart as well as diverse – mostly small and medium-sized – industrial companies from Baden-Württemberg.

Project information

Project title

Industry on Campus project (IoC) Stuttgart – Raw material and energy efficiency by process innovations

 

Project duration

November 2012 – Dezember 2016

 

Project partners

Scienctific partners:

  • Institut für Bio- und Lebensmitteltechnik, University of Stuttgart
  • Lehrstuhl für Molekulare Aufarbeitung von Bioprodukten (MAB), University of Stuttgart
  • Karlsruhe Institute of Technology (KIT), Karlsruhe
  • Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB, Stuttgart (Germany) (Coordinator)
  • Institute of Interfacial Process Engineering and Plasma Technology (IGVP), University of Stuttgart

Industrial partners:

  • Boehringer Ingelheim, Biberach
  • Lewa GmbH, Leonberg
  • Atoll GmbH (Repligen), Weingarten
  • Tosoh Bioscience GmbH, Stuttgart

Funding

We would like to thank the Baden-Württemberg Ministry of Science, Research and the Arts and the Pro3 Process Engineering Competence Network for supporting the project and the four industrial partners involved for providing cash and services (employees, equipment, consumables).