Development of a regulatory compliant cassette for large volume cell culture, cryopreservation, thawing and perfusion

This application relates to the development of the consumables and associated equipment to allow the widespread clinical delivery of a bioartificial liver (BAL). Since the liver is one of the few organs that can repair and regenerate, therapies enabling regenerative medicine, that is creating living functional tissues to repair or replace organ function lost due to damage, are expected to play a role in several areas of liver disease. A bioartificial liver machine can temporarily replace the functions of the liver, allowing the damaged liver to regenerate whilst protecting the patient’s other organs from the life-threatening damage that ensues during liver failure. If the toxicity can be mitigated, within 24 to 48 hours, the majority of liver cells will enter DNA synthesis, closely followed by mitosis enabling the liver to regenerate, restoring full function within a few days.