The Bio-Nespresso Project: The design of a small-scale manufacturing unit for personalized medicine production

Abstract

Cancer is the second leading cause of death globally. Researchers are continuously investigating new ways to develop and improve cancer treatments. Currently, remarkable progress has been made in immunotherapy. This treatment uses monoclonal antibodies to enhance or recover the patient’s immune system to destroy the cancer cells. However, these new treatments are expensive and not tailored to the patient’s need.

As a solution, Prof. Schellekens, from the Pharmaceutical department at the university in Utrecht, and his colleagues, proposed to add the antibody manufacturing to the magistral preparation procedures in a pharmacy. This allows the pharmacist to produce medicine for only one individual patient which does not have to comply with the regulations commercially produced medicine have to. This would result in a less expensive medicine which can be adapted to the patient’s specific needs.

To realize this idea, pharmacists need to be able to manufacture those antibodies. Therefore, the concept arose for creating a manufacturing unit to enable pharmacists to produce personalized medicine for patient use. This concept is called: the Bio-Nespresso.

Through user, context and technology analysis, the vision arose for designing a machine that enables a hospital pharmacist’s assistant to manufacture 30 grams of monoclonal antibodies in a sterile and reliable way, without requiring any specific knowledge about antibody manufacturing. To realize this, a new party was introduced: The Supplier. This party delivers all antibody production-specific elements to the hospital pharmacy, enabling the pharmacist and pharmacist’s assistant to only focus on patient care and executing the production process.

This project resulted in a first design of the Bio-Nespresso. The machine provides the ability to produce different doses of medicines, up to an entire treatment. All production-specific elements are integrated into four disposable units, which together form a closed system to prevent contamination. The machine will guide and monitor the users actions when installing these disposables.

The design demonstrates what the stationing of the Bio-Nespresso at a hospital pharmacy should look like. This resulted in concrete challenges which can serve as a starting point for the development of the proof of concept.