Next-generation fiber-optic biosensor solution to support bioprocessing quality control at pharma giants

Top-class research too often fails in finding its way to commercialization. FOx Biosystems, a KU Leuven spinoff company, partners with Comate in developing a performant market-ready product. Comate and Unitron collaborated in engineering an automated, medium-throughput analysis solution around the innovative biosensor technology of FOx Biosystems. The initial graphic system renders of Comate helped FOx Biosystems acquire capital for executing the development. FOx Biosystems’ CEO Filip Delport: “The engineers and designers of Comate are really making the difference in developing a technically refined analysis instrument, equipped with our revolutionary optical fiber sensing technology. We rely on Comate in every phase of the development process to maximize our chances for a successful market introduction. Our new biosensor tops existing instruments in speed, ease of use and operational efficiency. These assets are key elements to improve biomolecular interaction analysis across life science industry and research markets.” Just recently, FOx Biosystems additionally secured 4 million euros in capital with the Limburgse investeringsmaatschappij LRM, KU Leuven Gemma Frisius Fund and several biotech investors, to strengthen its development and sales organization. The headquarters of FOx Biosystems will move to Bioville, the life sciences bio incubator in Diepenbeek, Belgium.

“The engineers and designers of Comate are really making the difference in developing a technically refined analysis instrument, equipped with our revolutionary optical fiber sensing technology. We rely on Comate in every phase of the development process to maximize our chances for a successful market introduction.” – Filip Delport (FOx Biosystems)

A disruptive analysis approach is born

The sophisticated sensor technology for biomolecular interaction analysis originates from research performed at KU Leuven. Based on the doctoral research of Filip Delport, the startup FOx Biosystems was established. Currently, Filip Delport leads the company in the role of CEO.

FOx Biosystems toolFOx Biosystems data

 

The R&D results of current users are impressive, particularly in terms of working in ‘dirty’ samples and revealing new information on their biomolecules of interest. FOx Biosystems’ tools can disrupt the development and production of biological antibody-based medicines. Such pharmaceutical drugs are used to treat rheumatoid patients, persons suffering from Crohn’s disease, etc.

“The collaboration with Comate is built on our belief that its design and engineering specialists are perfectly fit for the challenge. From a realistic viewpoint, it did not make sense to develop the performant analysis machine by ourselves.” – Filip Delport (FOx Biosystems)

From a lab setup to a market-ready product

To bring the expertise of FOx Biosystems to the market, a team supervised by Filip Delport devised an elaborate business plan. FOx Biosystems established a partnership with Comate Engineering and design to help translate the laboratory analysis setup to a market-ready product.

“As part of our collaboration with FOx Biosystems, we explore the specific needs of pharmaceutical companies and research organizations, indicates Sander Van den dries, Comate Partner and Director. “We are developing the new biosensor for optimal use and maximal efficiency in realistic settings and focus profoundly on manufacturability.”

Filip Delport, CEO FOx Biosystems: “The collaboration with Comate is built on our belief that its design and engineering specialists are perfectly fit for the challenge. From a realistic viewpoint, it did not make sense to develop the performant analysis machine by ourselves.”

Making the technology tangible and attractive

The Comate specialists started their work after in-depth discussions about FOx Biosystems’ analysis tool and its anticipated use in medicinal development labs and production rooms. Very early on, the designers designed a graphic system render which realistically visualizes how the new instrument looks like. “The graphic illustrations of Comate were well received by investors and helped FOx Biosystems secure capital to execute the development of the device,” Delport said.

FOx Biosystems and Sander van den Dries from Comate

The technical engineering was executed by Comate in collaboration with Unitron. The project team developed a technically refined instrument that integrates the revolutionary optical fiber biosensing technology into an automated unit. “The solid, yet smooth casing was engineered as a single part using soft plastic molding,” explains Van den dries. “It supports pre-punched connections for faster interior assembly. The first prototype came with stylish status indicator LEDs which support the operation of the instrument.”

“The graphic illustrations of Comate were well received by investors and helped FOx Biosystems secure capital to execute the development of the device,”- Filip Delport (FOx Biosystems)

Digital bioprocessing quality control

After the user places the disposable sensor box and their samples into the instrument, the optical head picks up the disposable sensor tips and inserts them into the sample. In the optical head, light is emitted and travels through an optical fiber to the sensor tip and is reflected back to a spectrometer. Subsequently, the user sees the response displayed in real time as a wavelength resonance condition at about 600 nm dependent on refractive index close to the fiber optic surface.

Delport: “Thanks to our innovative biosensor technology, the graph shows clear shifts when specific biological interactions occur at the sensor tip. The size and kinetics of the wavelength shifts of the analyzed sample provide insight into specific antibody-related interactions that have taken place.” The gold-coated sensor tip is treated with a chemical solvent to add biological layer(s) on top.

The first customers & next-level developments

Delport says that the biosensor was engineered to handle up to four sensor units and is already in use at three academic institutions. “They mainly employ the white FOx 1.0 device of FOx Biosystems for diagnostic purposes and screening of nanobodies. The value for these customers is increased speed, ease of use, new types of assays and operational efficiency compared to other biomolecular analysis instruments on the market.”

Currently, the development continues and covers technically advanced engineering work to finish manufacturability, regulatory needs, integration with liquid handlers, and performance. Delport: “By adding miniaturized sample holders and the robotized sensor/sample handling, up to 350 samples can be analyzed with record time to result.”

FOx Biosystems toolFOx Biosystems team and Sander van den Dries from ComateFox Biosystems tool designed by Comate

 

Robust biomolecular analysis at a relentless pace

Comate contributed to the evolution of next-generation part assembly for the sensor optical connector. The 3D printed model has been replaced by two injection molded parts with easy assembly to mount the optical fiber. “Our Comate specialists designed the sensor support head and selected appropriate molding and production partners,” says Van den dries. The new sensor optical connector offers increased sensor centricity and accuracy and is perfectly suited for high-throughput analysis jobs.

“By proactively anticipating problems and proposing alternative solutions, Comate is able to quickly establish a new instrument version.” – Filip Delport (FOx Biosystems)

An additional advancement entails the customization of the sample holder, for temperature conditioning, shaking of a sample matrix and/or sample plate if needed. “By proactively anticipating problems and proposing alternative solutions,” says Delport, “Comate is able to quickly establish a new instrument version.”

Targeting large, international pharma corporations

Besides strengthening R&D, FOx Biosystems is also extending sales efforts by targeting large pharma corporations. The company is setting up partnerships and collaborations with established pharma suppliers and distributors to make its revolutionary biosensor an integral part of a process or diagnostic solution. Large pharma players see this as a viable offer with reliable delivery and agile support. This approach is more likely to deliver them the assurance they need to adopt the solution in their drug development and production operations.

The biosensor tool of FOx Biosystems nicely fits in the fast-evolving path to a new or updated biological antibody-based medicinal product or process. Delport: “Instead of sending off samples to another division or a third party, the new biosensor can be used for ‘real-time’ at-line measurements across the stages of discovery, development and production,. In a clinical diagnostics context, trough monitoring is one of many analysis types that illustrates the wide application reach of our biosensor.”

FOx Biosystems & Comate : A successful partnership

“The biosensor technology of FOx Biosystems has many advantages compared to existing biomolecular analysis instruments”, says Delport. “The ease of use, speed, cost-effectiveness and the minimal time for sample pre-processing, even in complex media, are key assets of our device. Currently, we are setting up a number of feasibility studies with international pharma companies. After completion of these studies, we expect a firm commercial uptake that leads to a solid install base in the pharma industry late 2020.”

“Now that we have progressed far enough toward a successful market introduction, we clearly see the value of our active collaboration with Comate. In every phase of development, the Comate specialists showed an extreme urge for quality, safety, appeal and intuitive use. – Filip Delport (FOx Biosystems)

“Now that we have progressed far enough toward a successful market introduction, we clearly see the value of our active collaboration with Comate. In every phase of development, the Comate specialists showed an extreme urge for quality, safety, appeal and intuitive use. We are convinced that our joined efforts will contribute to improve biomolecular interaction analysis in the life science industry and research market.”

 

Sander Van Den DriesSander Van Den Dries, Director of Comate Engineering & Design

 

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