Therapies using live cells offer the possibility of treatments for diseases and conditions that cannot be approached by conventional drugs.
Cells are being investigated for their abilities to reverse blindness, re-grow bone and nerves, restore the immune system and treat cancers for which there are no effective drugs.
Living cells, however, are fragile and short-lived outside their natural environment. A common approach to address these issues is to freeze the cells for storage but this causes problems when the cells are thawed again for injection into the patient. Many cell therapies simply cannot be frozen and for these products, complicated and expensive logistics are required to ensure their delivery to the hospital and the patient before their shelf life expires.
But how can logistics alone affect the commercial success or otherwise of a therapy?
The graphic below summarises the process for Sipuleucel-T to give an example.
The 18 hour shelf life of Provenge (Sipuluecel-T) meant that multiple GMP manufacturing plants needed to be built to address the geographical constraints of such a short time wondow before expiry of the therapy. Recovery of the extraordinarily high capital costs of building this manufacturing capacity impacted the price of the therapy. In turn, this affected reimbursement rates and prescriptions and, ultimately, the success of the business.
We believe that our cell encapsulation process would have had a dramatic impact on this therapy, by extending its shelf life so that a single manufacturing plant could have satisfied the entire market demand.