Allogeneic Cell Therapy

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Allogeneic cell therapy stands out in the field of cell and gene therapy for its scalability requirements with challenges similar to those of traditional biologics. A key challenge is the ability of the allogeneic manufacturing platforms to support growth of living cells for a large patient pool. The right partner can help you accomplish this and establish a robust, efficient, and scalable process that meets commercial demand. As you navigate in the evolving cell and gene environment, trust in your partner to deliver becomes critical. Flexible capacity to grow with your project will come into play and become an underlying key success factor for the long run.

iPSC manufacturing expertise

the next wave in cell therapy

We can help you overcome scalability challenges by offering expansion from 2D platforms to closed systems with our proprietary L7 GMP platform services. We have developed manufacturing processes to help you achieve scalable production in a GMP setting.

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Tissue sourcing & acquisition

Our in-house Bone Marrow Donor Program’s dedicated full-time staff can help you to navigate through the complexities of tissue sourcing to obtain the clinical and commercial starting material you need.

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Cell based immonutherapies

Whether you are developing an autologous or an allogeneic CAR-T therapy you will be focused on a similar goal, but will face very different obstacles, each with its own complexities. Let’s address those, together.

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Exosomes development and manufacturing

Leverage our knowledge in 2D/3D cell culture and viral manufacturing expertise, alongside the latest exosome characterization technologies to define your complete path for exosome manufacturing.

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Regulatory support dedicated to cell & gene therapy

Rely on a dedicated regulatory partner for the expertise and experience you need to de-risk your therapy's pathway.

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Supporting your therapy from concept to patient

By partnering with us, you partner with a growing team of scientists who have expertise in the development and manufacture (isolation, generation, banking, expansion and/or differentiation) of a broad spectrum of cell types including mesenchymal stem cells (MSCs), induced pluripotent stem cells (iPSCs), T-cells, natural killer cells (NK cells) and many others.

First-class expertise in manufacturing a broad spectrum of cell therapies

Cell and Product Type	Capabilities
Induced pluripotent stem cells (iPSC)	Reprogramming from cord blood, peripheral blood, fibroblasts, and bone marrow derived cells Expansion in 2D and computer-controlled 3D bioreactors Directed differentiation into all three lineages (ectodermal, endodermal and mesodermal) in 2D and computer-controlled 3D bioreactors
T-cells and Natural killer (NK) cells	Viral and non-viral genetic modification for CAR knock-in and TCR knock-out Expansion in 2D and computer-controlled 3D manufacturing systems
Mesenchymal stem cells (MSC)	Cell isolation from several tissues Expansion in large-scale 2D and computer-controlled 3D bioreactor
Exosomes and other extracellular vesicles (EVs)	Generation from different cell lines in 2D and computer-controlled 3D bioreactor Isolation, characterization and fill & finish
Hematopoietic stem cells (CD34+ stem cells)	Viral and non-viral genetic modification and differentiation into different hematopoietic lineages Expansion in 2D and computer-controlled 3D manufacturing systems
Human pluripotent stem cells (hPSCs)	Expansion in 2D and computer-controlled 3D bioreactors Directed differentiation into all three lineages (ectodermal, endodermal and mesodermal) in 2D and computer-controlled 3D bioreactors
β-cells	Differentiation from pluripotent stem cells and iPSCs in 3D computer-controlled bioreactor culture
Neurons	Neural stem cells, motor neuron and dopaminergic neuron differentiation from pluripotent stem cells and iPSC in 2D culture
Immortalized and engineered cell lines	Expansion in 2D and computer-controlled 3D manufacturing systems
Tissue engineered product	Expansion and maintenance in 2D cell culture systems

Technologies:

Our allogeneic services are based on a technology portfolio that enables robust and cost-efficient manufacturing for high production volumes of a single donor’s living cells.

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3D bioreactor manufacturing for cell therapies

Our allogeneic 3D process has been developed based on our extensive experience from handling a variety of bioreactors and cell lines to help you overcome the challenge of scale-up in allogeneic cell therapy.

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Exosomes development and manufacturing

Exosomes are small membrane vesicles that are secreted by a multitude of cell types, which play a role in cell to cell communication. They can serve as clinically valuable tools for early diagnosis, prognosis and potentially targeted treatment.

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iPSC manufacturing expertise

iPSC manufacturing systems enable scalable production of iPSCs in a cGMP setting, helping you develop and commercialize new therapies.

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Nucleofector™ Products

Nucleofector™ Products for efficient non-viral modification of primary cells, enabling generation of iPSC or CAR-T cells, or CRISPR-mediated engineering.

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Therapeak™ Cell and Gene Therapy Media

Quality and safety are crucial to allow reliable results in clinical processes and ultimately, protect patients’ lives. We are dedicated to providing high quality cell and gene therapy products for global customers via our TheraPEAK™ Line of media and rea...

Why choose us?

20+ years of cell and gene therapy GMP expertise
>120 process development projects in cell and gene therapy
World's first reported iPSC GMP bank
Scale-up expertise with 2D and 3D manufacturing platforms
>75 allogeneic cell therapy customers served globally
Expertise and regulatory consulting throughout your journey
Tissue acquisition dedicated team
An integrated offer of meda/buffers, viral and non-viral modification and consumables

cell and gene therapies