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Pluristem’s GMP Facility Gains EU Approval

To use PLX cell therapies in Phase I-III trials

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By: Kristin Brooks

Managing Editor, Contract Pharma

Pluristem Therapeutics’ new manufacturing facility has been approved by European auditors and has received the Qualified Person Declaration. The approval allows the company to use cell therapies manufactured at its facility in Haifa, Israel, in Phase I-III trials conducted in the EU.   The audit for manufacturing and cell expansion operations covered design, construction, and validation of the new facility, equipment, utilities, and quality management systems in accordance with GMP legislation, ...

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