A groundbreaking technique for delivering medicine that promises to eliminate the need for patients to spend hours at a time in hospital while drug infusions are dripped into their veins is being developed by researchers at a University of Bath spinout company.

The company, EnsiliTech, in partnership with the Centre for Process Innovation (CPI), has received £1.4 million from Innovate UK to refine its groundbreaking ensilication® technology so that it can be applied to life-saving antibody treatments.

Ensilication is a method for encasing biomolecules (proteins and nucleic acids) found in vaccines and medicinal antibodies in a silica shell. This wrapping technique keeps the biomolecules stable at room temperature and prevents them from clumping when they are mixed in a solution.

The new initiative between EnsiliTech and CPI – a British technology and innovation social enterprise that helps companies accelerate the development of their health-tech technologies to meet global healthcare needs – aims to improve sustainability of the antibody manufacturing process by eliminating the need for products to be stored and transported at low or ultra-low temperatures. The project will also explore the potential patient benefits of ensilicating antibody therapies.

Currently, antibody therapies are typically given to patients by intravenous infusion. Although treatment preparations vary, some antibodies need to be suspended in large volumes of fluid – up to 2 litres – and can take hours to administer through a drip. Antibodies tend to aggregate, or clump together, when they are compressed in a small volume, which is why some treatments need to be delivered in large volumes of fluid.

The EnsiliTech team believes their technology will make it possible to reformulate antibody treatments at far higher concentrations. As a result, less fluid will be needed to administer the same amount of active ingredient. The hope is that simple injections under the skin will eventually be possible for some treatments, significantly reducing the time patients spend receiving their medication.

Dr Asel Sartbaeva, co-founder and CEO of EnsiliTech, and researcher in the Department of Chemistry at the University of Bath, said: “We are excited to be working with CPI on such an important and impactful programme, as today access to antibody treatments is quite limited especially in low and middle-income countries, in part due to their dependence on ultra cold refrigeration*.

“Ensilicating antibodies will help us to remove this reliance. Also, by enabling higher concentration formulations, ensilication will allow for subcutaneous rather than intravenous administration, making treatments more patient-friendly and reducing the burden on healthcare facilities.

“This shift could enable more therapies to be administered in community or home settings, improving patient convenience and reducing hospital dependency.”

This initiative aligns well with the priorities set by the NHS and health services globally, which aim to free up hospital beds and enhance patient care within the community.

The antibody revolution

There is increasing interest in using antibodies in medical practice to treat a range of serious conditions. This treatment approach is already starting to revolutionise the treatment of some cancers, as well as infectious diseases, cystic fibrosis and autoimmune disorders such as Crohn’s disease.

For the new two-year project, the team will demonstrate the feasibility of using ensilication to deliver Trastuzumab – a monoclonal antibody treatment used to treat breast and stomach cancers.

The researchers will develop a new ensilicated version of Trastuzumab. They will also analyse both the energy savings and health-service cost savings from replacing the current formulation (which requires longer term storage at -80°C and transportation at a temperature of 2-8°C, and is delivered by infusion) with an ensilicated form of the drug (which would remain stable at room temperature, thanks to the ensilication process).

By the end of the project, the team hopes to demonstrate that ensilication can be applied to antibodies on a large scale, and that the technology can reduce the carbon footprint of storing and transporting antibodies, thereby creating savings to governments and health services. This would significantly improve access to antibody treatments, especially in low-and-middle-income countries.

The funding for this project comes from the UKRI’s Sustainable Medicines Manufacturing Innovation: Collaborative R&D competition.

*Currently, vaccines and medicinal antibodies must be stored and transported in low or ultra-low temperatures – from -70°C to 8°C. Maintaining refrigeration as medicines are transported to poor or remote communities is a huge logistical challenge, and the ‘cold chain’ often breaks down along the way, resulting in medicines spoiling and needing to be discarded. Breaks in the global cold chain are a serious and costly global public health issue.