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 With small patient-scale batch sizes, centralized production using scale-up processes is no longer applicable and scale-out approaches become the norm.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

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With small patient-scale batch sizes, centralized production using scale-up processes is no longer applicable and scale-out approaches become the norm.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

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.

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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Our approach to develop and manufacture 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 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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