EV Biologics announced today that it has signed a Letter of Intent (LOI) with Lonza Cell & Gene Therapy for Process Development and Gap Analysis for biomanufacturing of a novel therapeutic composition, comprising extracellular vesicles (EVs) and particles, as well as other secreted factors derived from selected stem/progenitor cells, such as mesenchymal stromal cells (MSCs).
Lonza is one of the leading global manufacturers serving the biotechnology and pharmaceutical industries. The Lonza Cell & Gene Therapy division is a leader in biopharmaceutical manufacturing and has invested in the development of EV production and purification processes.
EV Biologics CEO, Daniel Mckinney said ‘As we continue to advance our objective to optimize the therapeutic activity of EVs, including exosomes engineered for specific clinical indications, partnering with Lonza will facilitate a seamless transition between our ongoing scientific and technical innovation and scalable cGMP manufacturing of cell-derived and exosome-based therapeutics for preclinical research and future clinical trials.’
‘Lonza’s deep expertise in cGMP process development and scalable biomanufacturing of Cell & Gene Therapies will help EV Biologics to meet and exceed the rigorous requirements of the regulatory agencies and readily scale our technology for clinical trials and future commercialization, upon regulatory approval,’ said Dr. Jason Sanders, Chief Medical Officer, EV Biologics.
Exosomes are nano-sized vesicles that serve as mediators for cell-to-cell communication. With their unique nucleic acids, proteins, and lipids cargo compositions that reflect the characteristics of producer cells, exosomes can be utilized as cell-free therapeutics. – Cells, 2020
The intrinsic properties of exosomes in regulating complex intracellular pathways has advanced their potential utility in the therapeutic control of many diseases, including neurodegenerative conditions and cancer. Exosomes can be engineered to deliver diverse therapeutic payloads, including short interfering RNAs, antisense oligonucleotides, chemotherapeutic agents, and immune modulators, with an ability to direct their delivery to a desired target. – Science, 2020
Source – EV Biologics