Date: 2014-07-31
Type of information: Validation of a production plant
Compound: 3D cell therapy manufacturing processes
Company: Pluristem Therapeutics (Israel)
Therapeutic area: Regenerative medicine
Type agreement: validation of a production plant
Action mechanism:
Disease:
Details: * On July 31, 2014, Pluristem Therapeutics, a developer of placenta-based cell therapies, announced that it has completed the approval process and received final clearance from a fifth regulatory agency for its 3D cell therapy manufacturing processes in use at its new facility in Haifa. The latest approval comes from Israel’s Ministry of Health and follows similar clearances from the FDA, the European Union’s Qualified Person, Germany’s Paul Ehrlich Institute, and the South Korean Ministry of Food and Drug Safety.The Haifa facility has the capacity to produce approximately 150,000 doses of PLX cells annually, with batch-to-batch consistency. Pluristem\'s state-of-the-art GMP manufacturing site is located in MATAM industrial park, in Haifa, Israel and is equipped with 500 square meters of clean rooms in which PLX cells can be manufactured in sufficient quantities to support late-phase clinical trials and commercial demand at time of regulatory approval. Pluristem manufactures its products in full compliance with the FDA and European Medicines Agencies (EMA) current Good Manufacturing Practices (cGMP).
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