LCT granted approval to manufacture xeno products for human use
Living Cell Technologies Ltd (ASX:LCT) today announced it has received a licence from the New Zealand Government to manufacture a novel animal cell product for humans under Good Manufacturing Practice (GMP).
The NZ regulator MedSafe issued a formal letter to LCT recommending a Licence to Manufacture Medicines be issued which will allow the use of its xenotransplant products in human patients. The facility will be used to manufacture cell therapy products including DiabeCell® - LCT's diabetes product.
The scope of the GMP accreditation includes the company's proprietary micro-encapsulation process and also the manufacture and preparation of free islets from neo-natal pigs.