Pluri
Cell therapy CDMO with proprietary packed-bed technology and global regulatory approvals.
Listed on cdmo.directory
Full-service CDMO specializing in cell therapy manufacturing with GMP facilities, proprietary packed-bed expansion technology, and regulatory approvals from FDA, EMA, PMDA, and other key agencies for clinical-stage production. Headquartered in Haifa, Israel.
Modalities
Development & manufacturing
Structured CDMO capabilities from verified public sources.
Manufacturing (M)
Regulatory clearances
Services
- Cell Therapy Manufacturing
- Allogeneic Cell Therapy Manufacturing
- Cell-Line Development
- Process Development
- CMC Analytical Development
- Formulation Development
- Technology Transfer
- Cold-Chain Storage & Logistics
- Autologous Cell Therapy Manufacturing
- CMC Regulatory Submission Support
- Sterile Fill-Finish & Aseptic Manufacturing
About this organization
Overview
Pluri is a global CDMO focused on cell therapy manufacturing and process development. Since 2003, the company has advanced therapeutics through preclinical to Phase III clinical development, with over two decades of experience in cell expansion, process scale-up, and analytical development.
Manufacturing Capabilities
- Cell Types: Allogeneic products, Mesenchymal (MSC) and Pluripotent (iPSC) stem cells, immune cells, and gene-edited cells
- Process Formats: Adherent and suspension manufacturing processes, from lab scale to commercial scale-up
- Proprietary Technology: Packed-bed system for highly efficient, scalable, and automated production of adherent cells in perfusion format
- GMP Facilities: 600 m² of ISO 7 & 8 clean rooms, including aseptic filling suite; four self-contained, segregated cell therapy production suites; on-site WFI production; GMP warehousing; cryopreservation facilities
Service Areas
- Cell isolation and donor selection
- Harvesting and cell expansion
- Process development and scaling
- Process automation and technology development
- Final formulation development and filling
- Cryopreservation
- Storage, shipment, and thawing for administration
- Analytical method development
Regulatory Approvals
Quality systems and manufacturing facilities have been approved for clinical trial material production by the U.S. FDA, European Medicines Agency (EMA), Israeli Ministry of Health (MOH), Japan's PMDA, and Korean Ministry of Food and Drug Safety (MFDA).
Intellectual Property
Pluri holds over 250 patents and offers a proprietary, scalable manufacturing platform following GMP standards.
Certifications
Locations
Headquarters
Haifa · Haifa · Israel
USA Office
USA
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