Disposable Cell Culture System Development

Tissue Engineering for Human Antibody Generation

Innovation stands at the heart and represents the future of any technology organisation. ProBioGen realises not only the importance of innovation, but has also a deep understanding of what it takes to make innovation successful:

Novelty - whether it is an evolution or revolution, an innovation can be nurtured out of the existing know-how or be created from an original, sometimes even seemingly crazy idea. Either way, ProBioGen is committed to providing the right organisational environment to enable such ideas to flourish, grow and mature into commercially viable technologies. In addition, the company has also established a vast scientific network with universities and institutions for the exchange of ideas and exploration of technological boundaries.

Applicability - no matter how novel a technology is, research is of no use to the real world unless it can be applied to processes used in the development of products, which translate ultimately into direct benefits for the patient. Our research scientists work closely with their development and commercial counterparts to ensure that new projects have not only overall applicable targets, but also that the validity of these targets are constantly challenged and refined at each stage of development.

Marketability - the success of any innovation always lies in the fine balance between technological and commercial viability. Our commercial staff stays at the heart of all innovation project teams to ensure that science does not lose touch with the customer. We firmly believe that spotting problems, foreseeing trends and addressing unmet needs form the basis of innovation.

To summarise our approach to innovation, we go by the motto:

• No idea is too wild to explore
• No problem is too hard to solve
• No need is too small to meet
• No limit is too far to reach
• No boundary is too close to push

Disposable Cell Culture System Development

New disposable culture systems are developed at ProBioGen to meet the requirements of large scale protein manufacturing, as well as the needs in specific tissue engineering and cell therapy. Our R&D team has vast experience in working with medical grade materials, sterilisation procedures and the regulatory requirements for biopharmaceutical applications using such systems. Standardised workflows for design, prototyping and testing of novel disposable systems have been developed. They are currently applied to ProBioGen's internal developments on regenerative medicine. In addition, ProBioGen provides tailor made culture systems and testing capabilities to customers in the areas of in vitro drug screening and cell therapy.

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Tissue Engineering for Human Antibody Generation

Therapeutic antibodies play an increasingly important role in modern medicine. Apart from their highly specific effectiveness, these antibodies have to be extremely safe and must show excellent tolerability in patients. The ideal active substance is a fully human antibody derived from human B lymphocytes matured during a natural in vitro immune response to antigens. The primary goal of the research & development activities is the generation of high affinity human antibodies for therapeutic use in an organoid system. Using tissue engineering technology, a complex tissue culture of antigen presenting dendritic cells, regulatory T-cells, and antibody producing B-cells allows the understanding and experimental modelling of the immunological occurrences within an in vitro lymph node. In particular, the following development activities are essential:

Obtaining, cultivating and characterising of primary immune competent cells:

• Development of matrix substances for 3D tissue cultivation
• Development of miniaturised perfusion bioreactors and their culture process
• Development of bioassays for monitoring in vitro immunological activity

A complex organoid tissue culture can also be used as a model for screening immunmodulating substances and as a test system for pharmaceutical and immuno- toxicological studies. It offers the opportunity to reduce the need for animal experiments. These research & development activities are supported by grants from the German Government (BMBF) and are carried out in close collaboration with the Charité Hospital, Berlin, the Department of Biology at the Humboldt University, Berlin, the Deutsches Rheuma Forschungszentrum, Berlin (DRFZ), the Fraunhofer Institute for Biomedical Technology (IBMT, St. Ingbert) and the GKSS in Teltow.

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