TRANSFORMING CELL TERAPY - pluri-biotech.com

Introducing PluriCDMO

PluriCDMO offers a unique combination of experience, expertise and technological innovation for the manufacture of cell therapy products.

Founded in 2003, Pluri is a pioneer in cell therapy, developing advanced therapies and the technologies for their scalable, efficient and cost-effective manufacture.

We offer our customers unique technology, world class facilities and the experience and expertise of our pioneering team, to manufacture innovative new cell-based therapies.

Our Services

PluriCDMO is a full-service solutions-driven CDMO. We support our customers across a variety of activities:

Cell isolation and donor selection: supporting our customers in selecting the best starting materials for clinical development

Process Automation: integrating automation and proprietary technologies to drive products to market

Harvesting and cell expansion: employing advanced technologies for robust and scalable cell production

Final formulation development and filling: ensuring product quality from start to finish

Process development and scale up: increasing productivity without compromising quality

Cryopreservation: maintaining cell viability and functional integrity

Analytical method development & validation: ensuring product quality and consistency through development to market

Storage, shipment and thawing for administration: offering comprehensive logistics solutions to maintain product quality from our facility to clinical sites worldwide

Experience & Expertise-
A Proven Track Record

Over 400 batches have been manufactured in our GMP facility over the past 15 years, supporting Phase I- III clinical trials in the USA, Europe, Korea and Australia.

Pluri has experience with a broad variety of products and cell types both autologous and allogeneic cells, including IPSCs, MSCs, Immunological cells, Tumour Infiltrating Lymphocytes, Exosomes and viral vector-modified or gene edited cells.

Our CDMO team has successfully led cell culture manufacturing for 10 clinical trials globally, ensuring compliance with all regulatory standards. From cell expansion to freeze/thaw, to shipping, storage and stability, we have the know-how to scale-up your product efficiently and reliably.

Innovation and Technology

Underpinned by our expert team, Pluri’s unique 3D cell culture technology is at the heart of our offering. In order to support the cost-effective manufacture of billions of cells, Pluri has developed a scalable manufacturing platform that has been successfully used to manufacture a variety of cell types, from placenta-derived MSCs to primary immune cells.

Pluri’s 3D technology is based on a fixed bed of proprietary non-woven polymer matrix, which can be utilized in a conventional stirred tank bioreactor system in perfusion, providing a high-performance platform for the high-density culture of stem cells.
Pluri’s closed, automated system is scalable (> 100 fold), providing over 1010 cells from a 14L bioreactor.

End-to-End Solutions

From development of scalable manufacturing processes, to quality control, to global logistics, Pluri CDMO offers flexible, comprehensive support for your cellular therapy manufacturing needs.

Experience in autologous and allogeneic products, primary human stem cells, including Mesenchymal (MSC) and pluripotent (iPSC) cells, Immune cells, gene edited cells including viral vector and CRISPR-modified cells, and exosomes and secretome preparation.
Purpose-built GMP clean-room facilities comprising 6,458 sq ft of ISO 7 and 8 rooms, including an aseptic filling suite.
Experienced and trained employees with an average tenure > 5 years.
In manufacturing facilities and quality systems, Pluri meets the highest international standards, having manufactured products for Phase I, II and III clinical trials regulated by US FDA, European Medicines Agency, Israeli Ministry of Health, Japans PMDA, and Korean Ministry of Food and Drug Safety.
Pluri offers comprehensive and bespoke logistic and cold chain storage and shipment solutions for our customers, based on our extensive experience in supporting clinical trials in international jurisdictions.

TRANSFORMING CELL THERAPY

with scalable manufacturing technology

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