BioDevCenter: biologicals are the future of medicine

Not all advances in medical technology immediately catch your eye – take biologicals, for example. These are molecules that are biotechnologically designed for a specific application. In the German state of Baden-Württemberg, the Biologicals Development Center (BioDevCenter) and its infrastructure aim to bring them to market faster in the future.

In this MEDICA-tradefair.com interview, Dr. Thomas Joos and Prof. Bernd Pichler talk about the importance of biologicals in medical technology and the structure of the BioDevCenter in Reutlingen and Tübingen.

Dr. Joos, what is the objective of the BioDevCenter?

Dr. Thomas Joos: The Center is a lighthouse project selected by the German state of Baden-Württemberg. It is funded by the European Fund for Regional Development, which aims to strengthen research and development infrastructure across Europe. Its goal is to bring biotechnologically produced proteins, so-called biologicals, to the diagnostic and therapeutic market faster and more efficiently in collaboration with academic groups and companies.

What exactly are biologicals?

Joos: They are considered the future of medicine and can be used in a myriad of ways. For example, therapeutic antibodies have revolutionized cancer therapy and the treatment of rheumatic diseases. There are still gaps when it comes to the treatment of tumors, but personalized medicine holds great potential to make these types of treatments more targeted, personalized to consequently deliver more successful outcomes.

Biologicals are also important as it pertains to medical devices. They can be used as a technology to coat stents and other implants, to support wound care and wound healing or to aid drug absorption.

Prof. Pichler, could you give us more examples of the medical conditions biologicals can help treat?

Prof. Bernd Pichler: At the Werner Siemens Imaging Center, we primarily focus on diagnostic and theranostic processes, that being the combination of therapy and diagnostics. For example, we use specific molecules to radioactively label tumors for non-invasive positron emission tomography (PET) imaging to obtain a molecular profile of surface proteins. We subsequently label the same molecule with a therapeutic radioisotope to treat the tumor with radiation therapy.

We can also use the method to study whether tumor cells express specific receptors. Once we have identified them, we can use biologicals to deliver targeted cancer therapy. This is an interesting application for oncology as it facilitates the development of special molecules, which can be antibodies or smaller structures such as nanobodies or fragment antibodies.

Joos: We should also point out that Baden-Württemberg continues to be one of the top locations for the medical device industry and that biologicals are already being used in a variety of medical devices. Applications include dialysis membranes coated with albumin and heparin or substances that facilitate the controlled release of drugs. Several innovative approaches study the use of recombinantly produced spider silk. Other examples involve designer proteins to optimize the coatings of implants to prevent bacterial adhesion or support implant integration into the body. There are many exciting developments in this area, and we can deliver targeted support for these endeavors with the BioDevCenter.

Funding for the Center just launched in January 2023. Looking to the future, how do you envision the design and function of the Center?

Joos: For now, we can carry out the projects in the existing laboratories of the Werner Siemens Imaging Center or here at the NMI. That said, there are also plans for a new Institute facility and – depending on how the BioDevCenter evolves – it could even occupy one or two floors of the building.

Pichler: The infrastructure for research and the clinical application of biologicals is very expensive for two reasons. First, these are substances that are ultimately meant to be used inside the human body. That means they must be manufactured according to Good Manufacturing Practice (GMP) guidelines.

The second reason can be best explained via the imaging application. PET scans use short-lived radioisotopes, which we manufacture on-site and on-demand. For example, early in the morning in the Center, we produce a tracer labeled with the radioactive isotope fluorine-18, which has a half-life of two hours, designed for immediate application. You need a small-scale cyclotron (a reactor) for this, which goes along with radiation safety precautions and procedures due to its radioactivity.

The general operation costs of the laboratories run between two and three million euros a year, while the equipment we have here costs around 20 million. That is why it makes sense to consolidate all processes and ensure that the BioDevCenter not only obtains a regional, but also a nationwide infrastructure.

What are the next steps pertaining to the setup of the Center?

Pichler: We have several projects in different phases in the pipeline. One is conducting research with animals; another is preparing for GMP and subsequent clinical trials. Other molecules are still in the development stage.

Joos: At the NMI, we are investing in the further expansion of the laboratories at the same time. The project is funded for five years and we are now in an 18 to 24-month initiation phase. Over the next years, external projects can also be added to the pipeline. We are already in talks with several interested parties.