Professor Wallhäußer Award - Third Place

KyooBe Tech GmbH, founded in 2020 as a corporate start-up within the Bausch + Ströbel Group, offers innovative pharmaceutical manufacturing systems. KyooBe Tech focuses its technology development on two main areas: pathogen inactivation for vaccine production and the automated manufacturing of personalized cell and gene therapies.

The eFIT (electron Fast Inactivation Technology) system, utilizes low-energy electron irradiation (LEEI) for the rapid and continuous inactivation of pathogens. The key USPs of eFIT include lightning-fast inactivation (≤1 second) and scalability in throughput. Unlike conventional pathogen inactivation methods, eFIT completely avoids the use of chemicals, the generation of radioactive waste, or toxic operating substances. Instead, the system relies solely on electrically generated low-energy electron radiation.

This innovative approach enables a highly gentle inactivation process that largely preserves surface proteins critical to immune response — an essential factor in producing more effective vaccines. By eliminating toxic substances, eFIT not only reduces potential environmental impacts but also enhances occupational safety in production environments. The method's efficiency contributes to greater sustainability by significantly lowering energy consumption compared to prolonged thermal or chemical processes.

Thanks to its versatility, eFIT can be used to inactivate various pathogens and can be integrated into different biopharmaceutical processes, making it a flexible solution for diverse manufacturing needs.

Structure and Functionality of eFIT Lab

In 2024, KyooBe launched eFIT, the first LEEI-based system for pathogen inactivation. The system's core is a lead-shielded irradiation chamber, which consists of three main components: the electron beam, a cassette, and an integrated microfluidic chip (MFC).

A key innovation in the process is the generation of a continuous fluid stream, created using a precisely controlled vacuum. This vacuum transports the material to be inactivated from the input bag through the MFC and into the output bag. The electron beam is positioned at a defined distance above the MFC to irradiate the flowing material. This configuration ensures even irradiation across the entire material volume, which is crucial for effective pathogen inactivation.

The system's special advantage lies in its ability to monitor critical process parameters inline — such as temperature, irradiation intensity, and flow rate — allowing for precise control and regulation of the inactivation process.

The MFC itself features channels 1.5 mm wide and 100 µm deep. This shallow depth ensures that the electron beam can effectively penetrate the entire volume of the flowing material. The channels are sealed with a titanium foil, offering mechanical stability and efficient permeability to low-energy electron radiation. This geometry ensures the material is exposed to the beam in a thin, uniform layer with a controlled and steady flow rate, enabling precise and complete inactivation of pathogens.

The eFIT Lab platform, enables volumetric throughputs of up to 330 mL/h, depending on flow speed and irradiation intensity. The system is designed for vaccine development and small-batch production. Next step is the development of the eFIT Pro platform, which uses a macrofluidic chip and will allow high throughput rates of up to 100 L/h.

 

Scientific Validation and Application Areas

Developed over more than ten years of research by the Fraunhofer Society and further advanced by KyooBe Tech, LEEI technology (now eFIT) has reached industrial maturity. Numerous studies and publications have demonstrated that eFIT can successfully inactivate relevant pathogens. Moreover, the inactivated pathogens proved highly effective as potential vaccines in animal models, inducing strong cellular and humoral immune responses in mice — for example, against Respiratory Syncytial Virus (RSV) and Tick-borne Encephalitis Virus (TBEV).

Additionally, LEEI has been shown to be capable of inactivating immune cells (e.g., CD123-CAR-NK-92 cells) while reducing graft-versus-host disease (GvHD). This points to a promising future in allogeneic cell therapy, enabling its safety and clinical applicability. Another innovative application of eFIT is the depletion of potential contaminants in protein products. It has been demonstrated that Zika or BVDV viruses added to fetal bovine serum can be reduced by up to 6 log levels or more, while maintaining product quality.

With eFIT, KyooBe Tech delivers a groundbreaking solution to key challenges in biopharmaceutical production. Learn more about this technological milestone in vaccine manufacturing: kyoobe.tech/vaccine-manufacturing