Confidently scaling cell and gene therapies

Cell and gene therapies hold great curative promise with a rapidly rising number in clinical trials. However, even before the most pressing pharmaceutical challenges have been resolved, manufacturers are already confronted with the next challenge: high development and production costs. This calls for a shift from manual and fragmented to automated processes.

The numbers are clear; cell and gene therapies (CGTs) are on the rise:

+40% annual growth expected through 2030
CGTs make up 34% of all injectable therapies in development
Current treatment costs can reach up to $4 million per patient
Biologics dominate the development pipeline (84%) despite just 12% market share

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Laboratory worker in protective gear handling sterile equipment.

Scalability from R&D to high-volume production

A key reason for the high cost of CGTs is the continued reliance on manual production processes. These labor-intensive procedures limit scalability and consistency. As a strategic partner to the pharmaceutical and biotech industry, Syntegon addresses these challenges directly. In early stages, containment equipment from our subsidiary Klenzaids ensures GMP-compliant production with aseptic, bioclean, and containment solutions. Automated systems make the leap from clinical to commercial production both efficient and compliant. For example, Versynta microBatch, a gloveless production cell designed for very small batches, eliminates manual intervention inside the isolator, ensuring compliance with regulations like Annex 1. Moreover, a variety of fully automated filling solutions is available for higher production volumes.

Doctor holding a stethoscope in front of white coat.

Mastering GMP compliance with expertise and services

CGT developers with little prior experience in commercial production often face steep learning curves when moving toward GMP-compliant manufacturing. Our experts support them throughout this critical phase with expertise and services from our subsidiary Valicare – from facility design and PQM strategies to the implementation of fully GMP-compliant processes. Modular cleanroom concepts like cult.tainer enable a fast, step-by-step approach to compliant production environments, helping manufacturers avoid costly regulatory delays.

Integrated fill-finish and cold storage solutions

More than 99 percent of cell and gene therapies are delivered as injectables, around half of them are filled in vials. Successful CGT production thus often hinges on the right liquid filling equipment that combines economic efficiency with strict aseptic or sterile operation. Our broad portfolio is tailored to these needs. For example, the ARF and ALF platforms enable high-quality larger-batch vial filling, while single-use systems such as peristaltic pumps offer sterile filling options. End-to-end solutions for RTU containers are particularly suited to minimizing product loss. In addition, Telstar’s ultra-low temperature freezers ensure safe and customizable long-term storage – reaching temperatures as low as -86 °C, which is particularly relevant for preserving gene therapies and, in some cases, cell-based products.

3D rendering of a DNA double helix on a dark background.

Strategic partnership for the future of CGTs

From initial consultation to automated equipment and comprehensive services, Syntegon offers integrated solutions and seamless support during the entire project. We help CGT manufacturers streamline production, secure regulatory compliance, and bring therapies to market faster – helping reduce cost drivers throughout the production lifecycle. With decades of experience, a global reach, and a forward-thinking technology approach, we empower biopharmaceutical companies to transform the potentials of cell and gene therapies into accessible, life-changing treatments.

Ready to scale your cell and gene therapies to the next level?

Contact our experts today