Understanding Extracellular Vesicles (EVs)
Exosomes (or EVs) are natural, nano-sized particles produced by a variety of cell types that transmit materials and genetic instructions to co-ordinate cellular activities in our bodies.
EVs are key to cell-to-cell communication, and deliver ‘cargoes’ — such as protein and nucleic acids — to other cells to influence their behaviour. This form of communication can be directed to adjacent cells or those in distal tissues.
EVs play important roles in health and disease. One of their most promising features in terms of their natural therapeutic effects is their ability to regenerate tissues. It has become clear that the EVs that stem cells release, rather than the stem cells themselves, are responsible for much of the health benefit of stem cell transplantation. Due to their size, stability and composition, EVs are also likely to overcome some of the issues with drug delivery, including safety concerns, and the logistical issues associated with storage and transport of a ‘live’ product.
Because they naturally transfer active ingredients into cells, EVs also hold promise for delivering medicines across the body, particularly in areas that have been traditionally difficult to target such as tumours, the central nervous system (CNS) and the lungs.
Although no EV medicines have yet been approved for sale globally, their potential to treat currently untreatable diseases make them an extremely compelling development opportunity. Exopharm is one of only two exosome companies listed on public markets worldwide and one of a handful of companies taking exosome medicines into clinical trials and eventually commercialisation.
Manufacturing
Despite promise of administering exosomes as a cell-free treatment, the therapeutic exosome market has been held back by one key technological challenge: an efficient exosome extraction and purification process technology that would enable the manufacture of exosome-based medicines at clinical and then pharmaceutical grade and scale.
Exopharm’s Ligand-based Exosome Affinity Purification (LEAP) Technology provides a key step in the downstream manufacturing process to isolate and purify exosomes from a variety of cell sources. LEAP Technology is a proprietary affinity-based purification method that works by selectively recognising and binding the surface of EVs. Affinity purification techniques are widely used by the biopharmaceutical industry and are demonstrably scalable.
LEAP Technology has provided access to high-purity exosomes and has launched a virtuous circle of innovation at Exopharm, allowing it to solve other manufacturing and characterization challenges and to bring an exosome-based medicine into human clinical trials for the first time. This places Exopharm at the forefront of this emerging field worldwide.
To discuss our capabilities in EV manufacturing, contact our Business Development team at partnering@exopharm.com.
EV Engineering
Exopharm is using its manufacturing capability and know-how to develop engineered EVs (EEVs). These EEVs are designed as precision medicines for indications areas such as genetic disease, neurodegeneration, viral infection and cancer. They work by delivering drugs or other cargo into specific cells.
Our EEV products leverage three key technologies:
