Pluristem Therapeutics’ cGMP Facilities Approved for Clinical Manufacturing in Europe
Business Wire
Posted: 2009-02-02 04:00:00
Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (DAX:PJT), a bio-therapeutics company dedicated to the commercialization of unrelated donor-patient (allogeneic) cell therapy products for a variety of disorders, announced today that the Company has received approval (in the form of a declaration) from Biotec Services International Limited, stating that Pluristem's Investigational Medicinal Product (IMP), PLX-PAD, is manufactured in accordance with standards of Good Manufacturing Practice (GMP), equivalent to those applied in the EU. Biotec Services is an international clinical trials supply company providing release services of the IMP into the European Union by a Qualified Person (QP).
Upon IND and IMPD clearance by the regulatory authorities, Pluristem plans to initiate clinical trials in Europe and in the U.S.A., administering PLX-PAD to patients afflicted with critical limb ischemia, which has not responded to traditional medical or surgical interventions.
“We have invested approximately $2 million at Pluristem, building a state of the art facility and training our team to manufacture our cell therapy product, PLX-PAD,” stated Zami Aberman, Chairman, President and CEO of Pluristem. “The successful audit of the manufacturing site by a Qualified Person from the UK is assurance that our product is manufactured as required under GMP standards.”
About Qualified Person
Following the implementation of the Clinical Trials Directive 2001/20/ EC in May 2004, any company wishing to undertake European clinical studies has to comply with a series of regulations. A Qualified Person (QP) is required to release supplies of Investigational Medicinal Product (IMP) that have been manufactured outside the EU for use in European clinical studies. The QP conducts audits of manufacturing facilities outside the EU, ensuring that each batch has been manufactured in accordance with current Good Manufacturing Practices (cGMP) guidelines. |
