20+ Years of Cell & Gene GMP Experience
>75 Allogeneic CT Customers Served Globally
Pioneering Emerging Modalities Including iPSCs and Exosomes

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 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.

Expertise manufacturing a broad spectrum of cell-types

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.

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

Natural Killer (NK) and T-cell therapies (CAR-T, TCR, TIL, T-Reg)

NK and T-cell therapies require specialized expertise process development, cell engineering, cell culture, and cell expansion. Lonza has extensive experience in the development and manufacture of NK and various T-cell therapies, including CAR-T, TCR, TIL, and Treg cells. We support multiple commercial and late-phase products across our network with a strong history of delivery, working with some of the pioneers in the allogeneic space. Our large, diverse and experienced team of scientists in process development has the expertise to choose the right technology for your product and demand, with a scale-appropriate model to start clinical trials early, aiding a smooth transition into a larger scale process, when the need comes.

woman working in lab T/NK

Induced pluripotent stem cells (iPSCs)

iPSCs are a powerful tool for cell therapy development. Lonza is a pioneer in the development and manufacturing of iPSCs, including reprogramming, cell expansion and differentiation into various cell types: T-Cells, NK Cells, MSCs, Beta Cells, Neurons, Cardiomyocytes amongst others. We have the expertise to optimize iPSC culture conditions, ensure consistent cell quality, and optimize robust differentiation protocols. Our teams of scientists regularly publish research on advancements in the field of iPSC development, characterization and manufacturing. Furthermore, Lonza manufactured the world’s first reported GMP bank for the National Institute of Health (NIH).

Learn more

man working with equipment in lab MSCs

Mesenchymal stem cells (MSCs)

Lonza has been developing and manufacturing MSCs since the early 2000s, including tissue sourcing and cell banking, supporting multiple late-stage projects over the years. We have the expertise to optimize MSC culture conditions, ensure consistent cell quality, and develop robust and compliant 2D and 3D manufacturing processes for our customers. We are experts in industrial manufacturing of MSCs, having produced hundreds of GMP batches. We have developed and optimized an operational model that reduces Cost-of-Good (COGs) to serve large-scale, commercial demand.

technician working with Thermo Scientific tank

Hematopoietic stem cells (HSCs)

Are a valuable source of cells for cell therapy and regenerative medicine, but their use can be limited by the availability of suitable donors and the challenges associated with HSC isolation, culture, and expansion. With hundreds of GMP batches produced, Lonza has extensive experience in the development and manufacture of HSCs, including tissue sourcing, cell isolation and expansion. We have the expertise to optimize HSC culture conditions, ensure consistent cell quality, and develop robust manufacturing processes.

Contact our experts

two men laughing in lab - iPSCs

Developing your autologous cell therapy manufacturing

Our approach to developing and manufacturing your therapy from concept to commercialization and beyond

Our New Product Introduction (NPI) and Lifecycle program, maps out your entire journey to commercialization. It accounts for each key milestone with checkpoints, to ensure you meet all required quality standards as your autologous cell therapy progresses towards commercialization. The NPI program leverages our heritage and longstanding experience in establishing cGMP manufacturing standards. It combines both corporate and local quality standards customized for cell and gene therapies, to de-risk your journey to commercialization.

Learn more

NPI graphic

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Services and Technologies

Services
Cell & Gene Therapies Process Development
Cell & Gene
Cell & Gene Therapies Process Development
Identify critical quality attributes while creating a robust, scalable and reproducible cGMP clinical/commercial manufacturing pro...
/cell-and-gene/process-development
Cell & Gene Therapies, cGMP Manufacturing
Cell & Gene
Cell & Gene Therapies, cGMP Manufacturing
Access a systematic approach to tech transfers, manufacturing and pre-license inspection readiness to reliably take your therapy t...
/cell-and-gene/cgmp-manufacturing
Cell & Gene Regulatory Services
Cell & Gene
Cell & Gene Regulatory Services
Partner with our dedicated cell & gene regulatory team to define the optimal regulatory strategy for your therapy's accelerated pa...
/cell-and-gene/regulatory-services-cell-gene
Bioassay Services
Cell & Gene
Bioassay Services
We offer two main strategies for your bioassays development for a successful product characterization towards GMP manufacturing. L...
/cell-and-gene/bioassay-services
Clinical Tissue Acquisition Services
Cell & Gene
Clinical Tissue Acquisition Services
We can help you navigate the complexities of human tissue sourcing and acquisition. Meet regulatory guidelines to obtain clinical ...
/cell-and-gene/tissue-acquisition
Technologies

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Why work with us?

Extensive experience and expertise in the development and manufacture of cell therapies to take your product to market.

  • Our dedicated process development teams will help you to de-risk your manufacturing process before transferring it to GMP manufacturing and scale-up as appropriate. We are equipped to support the full analytical development lifecycle from new assay development to assay validation to supporting late stage products.
  • 8+ years of clinical manufacturing expertise within a wide range of immunotherapy applications.
  • Extensive experience with 2D and 3D immunotherapy bioprocessing.
  • Proprietary non-viral 4D-Nucleofector™ transfection technology to enhance robustness.
  • Best practices in process development characterization to address some of the key challenges for cell & gene therapy manufacturing include: eliminate or minimize open / manual unit operations; optimize of sub-optimal unit operations; implement in-process control / decision points; scale-out / automation and process characterization.
  • An end-to-end service offering including:
    • Phase appropriate assay and process qualification
    • Full characterization
    • Tissue acquisition
    • Cell processing (isolation, activation, editing, expansion and purification)
    • Formulation and fill & finish
    • Supply chain orchestration
    • Lifecycle regulatory support
  • R&D team focused on further developing next generation scalable and closed GMP technologies
Our global network
Cell & Gene therapy manufacturing services
Geleen building
Geleen, The Netherlands
Sienna site
Siena, Italy
Singapore - Mammalian, Cell & Gene Technologies
Tuas, Singapore
Cell and Gene
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Careers

By joining Lonza, you will get to work with some of the world’s top experts in the space, while developing advanced therapies with a potentially life-saving outcome.

Behnam Ahmadian - Global Head of Process Development 
Behnam Ahmadian Baghbaderani

Global Head of Process Development

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