Services

Full-service, solution-driven CDMO, supporting our partners throughout the manufacturing value-chain.

areas of expertise and capabilities include:

  • 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

Adding value through manufacturing process development

Our aim is to support our partners from the earliest stage, using our decades of experience to help develop productive, scalable and reproducible manufacturing processes. Pluri CDMO’s team has broad experience, including allogeneic products; Mesenchymal (MSC) and Pluripotent (iPSC) stem cells; immune cells; and gene-edited cells. We have worked with adherent and suspension manufacturing processes, from lab scale to commercial scale-up.

Innovation and Proprietary Technology

In some cases, it may be appropriate to implement our proprietary packed-bed system. This technology, developed over many years at Pluri, can support highly efficient, scalable and automated production of adherent cells in packed-bed, perfusion format.
This system has been used to support the production of a variety of different cell types with high levels of control, offering considerable advantages over conventional systems.

Manufacturing and
Quality Systems

Hundreds of batches have been produced in our versatile and flexible GMP facilities, comprising 600M (6,458 square feet) of ISO 7 & 8 clean rooms, including an aseptic filling suite. There are four self-contained, segregated cell therapy production suites; clean utilities including on-site WFI production; GMP warehousing; product storage; and cryopreservation facilities.

We offer a wide range of analytical capabilities on site as well as method development, method transfer, qualification and validation. Our quality systems and manufacturing facilities have been approved for production of material used in clinical trials by regulatory agencies worldwide.

Logistics and Supply Chain

With a long history of supporting clinical trials in international jurisdictions, Pluri has developed considerable experience in meeting the logistical challenges inherent in supplying cell-based products to patients around the world. We offer extensive knowledge of cold chain solutions in many countries and can provide bespoke solutions for our partners to ensure safe disposition of their products.

©2023 Pluri Inc.

©2023 Pluri Inc., its logo, brand, product, and process names appearing in this issue are the trademarks of Pluri™ Inc. or its affiliated companies. All other brand, product, and process names appearing are the trademarks of their respective holders. Reference to or use of a product, or process other than those of Pluri™ Inc. does not imply recommendation, approval, affiliation, or sponsorship of that product, or process by Pluri™ Inc. Nothing contained herein shall be construed as conferring by implication, estoppel, or otherwise any license or right under any patent, copyright, trademark, or other intellectual property right of Pluri™ Inc. or any third party, except as expressly granted herein.  All information herein is for general information only and is subject for change without notice.

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