Autologous cell therapies are at the forefront of the cell and gene therapy revolution. Here, cells from an individual patient are collected, processed ex vivo and then returned to the same patient.

The manufacturing of such personalized medicines poses complex new challenges. With small patient-scale batch sizes, centralized production using scale-up processes is no longer applicable and scale-out approaches become the norm. Today, the cost of production still represents a major hurdle on the path to market. New technologies are needed that enable robust and cost-efficient manufacturing, and yield replicable high quality medicines. Moreover, for autologous therapies, the patient stands at the beginning and end of the supply chain. Proximity of manufacturing to patients is key to reduce supply chain complexity.

While the therapeutic opportunities for patients are exciting, the stakes for patients and drug developers are high. Partnering in such a dynamic environment can improve the chances of success.

Process development excellence

With our highly tailored, step-by-step approach to commercial readiness, you can be sure of a robust, reproducible and commercially viable Good Manufacturing Practice (GMP) process, de-risking your path to successful commercialization.

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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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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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Technologies


Our autologous services are based on a technology portfolio that enables robust and cost-efficient manufacturing of patient-specific cell therapies.


A connected vein-to-vein network for successful scale-up and out


Global tech transfers across Lonza sites

MODA™-ES Platform for EBR* and manufacturing traceability

Manufacturing, tracking, scheduling software (Vineti is Lonza's preferred SCO* partner)

Shipping and logistics across the globe (Cryoport is Lonza's preferred logistics partner)

*EBR: Electronic batch records | SCO: Supply Chain Orchestration

We continuously develop new technical solutions, in house and through partnerships, to meet your future manufacturing requirements. Our partners for our vein-to-vein network include:

  • Vineti for supply chain orchestration (SCO), to enable real-time end-to-end connection between manufacturing and points of care while optimizing manufacturing capacity management. This partnership comprises fully integrated offering including logistics, scheduling, distribution, Chain of Condition, Chain of Custody, Chain of Identity, and Lonza’s proprietary solutions including MODA-ES™. Read more
  • Cryoport for the transport and delivery of patient tissues on a global basis. The Partnership incorporates Cryoport’s Cryoportal® Logistics Management Platform, SmartPak II™ Condition Monitoring System and Cryoport’s unique Chain of Compliance™ for regulatory solutions. Read more

Close to the patient


In autologous therapies, proximity to patients matters. Our global network of five facilities across Europe, North America and Asia brings us closer to you and your patients thereby minimizing your logistical and supply chain risk.

cell and gene therapies


our global network

Our global network of 4 centers of excellence spans across 3 continents to serve patients across the world. The sites in Pearland, TX (USA) and Geleen/Maastricht (NL) offer a fully integrated range of cell- and gene-therapy services including process development, bioassay services and clinical and commercial product supply as well as regulatory affairs consultancy for submission support. Our sites in Portsmouth, NH (USA) and Singapore (SG) serve both as clinical and commercial manufacturing sites for cell therapies.

Portsmouth, NH, USA

Clinical Manufacturing, Commercial Manufacturing, Cell and Gene Manufacturing

101 International Drive
Portsmouth, NH 03801
United States of America

Houston, TX, USA

Clinical Manufacturing, Commercial Manufacturing, Cell and Gene Manufacturing, Viral Vector Manufacturing

14905 Kirby Dr
Houston, TX 77047
United States of America

Tuas, Singapore

Production, Sales & Support

35 Tuas South Ave 6
Tuas 637377
Singapore

Geleen, The Netherlands

Clinical Manufacturing, Commercial Manufacturing, Cell and Gene Manufacturing, Process Development, Analytical Development

Urmonderbaan 20B
Geleen
Netherlands

Why choose us?

  • 20+ years of cell and gene therapy GMP expertise
  • >120 process development projects in cell and gene therapy
  • Experience with a variety of autologous cell therapy automation technologies
  • Integrated supply chain solutions through partnerships
  • A global network of manufacturing sites across 3 continents
  • Expertise and regulatory consulting throughout your journey
  • Tissue acquisition dedicated team
  • An integrated offer of media/buffers, viral and non-viral modification and consumables