The cell therapy firm plans to take its Autologous Insulin Producing (AIP) cell transplantation approach to managing diabetes into Phase I clinical trials in the near future, and to support this has established a facility in Walloon, Belgium.
Speaking with Biopharma-Reporter.com, Orgenesis CEO Sav DiPasquale said the facility “will operate in Belgium and therefore take advantage of the country’s favourable attitude to life sciences, with access to grant funding and tax incentives.”
Furthermore, amongst several firms Orgenesis has teamed up with, ATMI Life Science is already established in Belgium and DiPasquale told us how the facility will use ATMI’s Integrity Xpansion disposable bioreactors to “reduce manufacturing costs and risks.”
ATMI has “developed a disposable bioreactor for adherent cells (cells that need a surface to be attached to) and they are experienced with liver cells which are the cells we use as a source,” he said
“ATMI provides a smaller and more cost effective footprint solution to grow and manipulate cells versus large and labour intensive processes used today.”
The firm hopes to be producing clinical grade materials following GMP certification within the next 12-15 months.
Cell Therapy for Diabetes
Taking cells out of a patient with insulin dependent diabetes and modifying them is not a new process, as pancreas islet transplantation - first developed in 1988 according to journal CellR4 - is currently approved and has been applied in a number of cases.
However, there are certain limitations with such a therapy including a shortage of donor tissue and rejection rate by the patient' immune system. Orgenesis’s cell therapy differs, according to DiPasquale, due to the use of autologous cells which avoids the need for immune suppressant therapy and is thus a distinct advantage.
“It based on a process called transdifferentiation,” he said, and “pre-clinical research in diabetic mice and rodents, both in-vitro and in-vivo using human liver cells have been transdifferentiated and produce insulin in a glucose regulated manner.”
Location, Location, Location
Biopharma-Reporter.com asked DiPasquale if such therapy meant cell manufacture must be located in close proximity to a patient or a trial site.
“Technically there is no issue with having the patient or trial in different locations as these cells can be transported,” he said, however, “for our process, we plan to keep the patient and the trial location in the same geographical area at least to begin with.”
In the long-term Orgenesis plans to co-locate manufacturing facilities in other geographical areas, if it makes economic sense, he added.