Autologous Cell and Gene Therapies Manufacturing

75+ Process Development Projects

We provide best-in-class Process Development services to de-risk your manufacturing process for cGMP clinical and commercial manufacturing.

60+ Clinical & Commercial Manufacturing Programs

Clinical and commercial manufacturing.

A Global Network

With five clinical and commercial manufacturing sites across three continents, we can provide patient proximity for your therapy.

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 With small patient-scale batch sizes, centralized production using scale-up processes is no longer applicable and scale-out approaches become the norm.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 for consistent reproducibility at scale. Moreover, for autologous therapies, the patient stands at the beginning and end of the process for a linked chain of identity (CoI) and chain of custody (CoC). This requires a heavier focus on the proximity of manufacturing to patients 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.

The top four challenges for autologous cell therapy developers begin with the long-term commercial viability of the drug product and the ability to provide a reasonable cost of goods (COGs) that can be supported by market reimbursement. This major hurdle is emphasized due to the quality and variability of the starting material, the inevitable disease progression from the time of tissue collection to treatment and the logistical challenges of the flexible scheduling mechanisms and scale-out challenges. We offer an end-to-end solutions and a streamlined manufacturing approach to help customers overcome these challenges.

Chimeric antigen receptor (CAR) T

Chimeric antigen receptor (CAR) T is an immunotherapy that genetically modifies a patient’s T cells to recognize specific targets on cancer cells leading to potentially curative outcomes. We have extensive experience with several different technologies for each of the unit operations, i.e. isolation, gene modification and volume reduction. With hundreds of CAR-T batches manufactured each year and capacity expanding across our global CGT network, Lonza stands out as an experienced and reliable partner to support your CAR-T product from bench to IND, tech transfer to clinical, and from clinical to commercial. Our flexible operational models and global network capabilities can support early phase low-volume demands up to large-scale commercial demand with a focus on optimizing Cost-of-Goods (COGs) and securing critical capacity to meet patient needs.

Tumor Infiltrating Lymphocyte (TIL)

Tumor Infiltrating Lymphocyte (TIL) is a cell therapy derived from a patient’s own TILs, enhanced through engineering, then infused back into the patient for treatment of solid tumors. Lonza has more than 10 years of experience with TIL process development, tech transfer and clinical manufacturing. We have extensive experience in tissue dissection and tissue processing, and other unit operations that are unique challenges of TIL processes. As TIL therapies mature in the market, Lonza is well positioned as an industry-leading partner to bring TIL therapies to commercial on our established commercialization platform.

Hematopoietic Stems Cell (HSCs)

We have experience with Hematopoietic Stems Cell (HSCs) derived autologous cell therapies in process development, bioanalyical platforms, tech transfer and clinical manufacturing. Successful delivery of HSCs rely on a robust process and Lonza’s process development team has over 15 years of experience with developing, optimizing and scaling HSCs therapies into a reproducible GMP process. Lonza has expertise and experience with several different technologies for each of the unit operations, i.e. isolation, gene modification and volume reduction. Furthermore, we have extensive experience manufacturing HSCs across our global network for the US and EU markets.

T-cell receptor (TCR)

We have more than five years experience with T-cell receptor (TCR) based adoptive therapy in process development, bioanalyical platforms, tech transfer and clinical manufacturing. Unique unit operations, including gene editing and introducing the TCR, are critical for TCR manufacturing processes and Lonza can provide solutions to your development needs to scale your process for GMP. Furthermore, our experienced teams will de-risk tech transfer of your TCR process through our proven new product introduction platform to streamline path to clinical success.

Regulatory T (T-reg)

T-reg is a therapy that engineers patients Regulatory T (T-reg) cells for the treatment of serious automimmune and chronic inflammatory health conditions. Unique unit operations, including cell expansion and cell sorting, are critical for T-reg manufacturing processes and Lonza can provide solutions to your development needs to scale your process for GMP. Furthermore, our manufacturing teams are experienced with T-reg processes and can de-risk tech transfer of your T-reg process through our proven new product introduction platform to streamline path to clinical success.

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.

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Industrializing your manufacturing process

With small patient-scale batch sizes, centralized production using scale-up processes is no longer applicable and scale-out approaches become the norm for Autologous cell therapy manufacturing. 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.

At Lonza, we are technology agnostic and as the most experienced cell therapy CDMO, we have experience using the majority of all technologies required for autologous cell therapy manufacturing, testing and release. In addition, we are also introducing proprietary technologies to address specific challenges or automation and digitalization of your manufacturing process, including:

Electronic batch-records and manufacturing traceability with our MODA™-ES Platform
Closed, automated manufacturing with our Cocoon® platform
Standard unit operation platforms for a streamlined path into GMP manufacturing

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A vein-to-vein network of partnerships to address the need for just-in-time manufacturing from Autologous cell therapies

Autologous cell therapies are at the forefront of the cell and gene therapy revolution. Cells from an individual patient are collected, processed ex vivo and then returned to the same patient as the most personalized treatment possible today.

This vein-to-vein journey brings a new need to pharmaceutical manufacturing to produce and deliver medicines to your patients in the shortest possible timelines, without any shelf-life. We refer to it as “just-in-time manufacturing”.

Our role as a manufacturing partner has evolved to integrate the entire supply-chain network around the manufacturing of our customers’ autologous cell therapies. We are fully connected and in sync with the fluctuations of patient demand.

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A global network of manufacturing sites across three continents

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

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