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Cell & Gene Therapy Manufacturing Systems

Engineering scalable systems for advanced therapy production.
Integrated process systems supporting the transition from clinical development to commercial manufacturing.
Section of a panel with single use hoses and valves
Hands arranging single use hoses on a panel

From innovation to manufacturable therapies. Efficient scale‑up to industrial manufacturing.

Cell and gene therapies represent one of the most transformative areas in modern medicine. These advanced therapeutics require specialized manufacturing environments capable of supporting complex biological processes while maintaining strict quality and regulatory control.

ZETA supports advanced therapy developers and manufacturers with integrated process systems designed for cell culture expansion, viral vector production, purification, and cryogenic handling. Our engineering expertise enables scalable manufacturing environments that support both clinical-stage production and commercial manufacturing of advanced therapies.

Manufacturing platforms for advanced therapies

Cell and gene therapy production relies on specialized manufacturing platforms designed to support both cell expansion and genetic modification processes. These systems must operate within tightly controlled environments to ensure the safety, purity, and potency of advanced therapies.

Typical manufacturing systems include:

An icon showing cell cultures in dark and light blue

Cell expansion bioreactors

Controlled environments used to expand therapeutic cell populations for treatment.
An icon showing cell cultures in dark and light blue

Viral vector production systems

Bioreactor and purification platforms used to manufacture viral vectors required for gene delivery.
An icon showing cell cultures in dark and light blue

Downstream purification technologies

Filtration and chromatography systems that isolate viral vectors and therapeutic materials.
An icon showing cell cultures in dark and light blue

Cryogenic storage and handling systems

Controlled freezing and storage solutions used to preserve sensitive biological materials during manufacturing and distribution.

Key challenges in cell & gene therapy manufacturing. Engineering reliable processes for complex biologics.

Cell expansion

Scaling therapeutic cell populations while maintaining viability and biological function.

Cryogenic preservation

Maintaining cell stability during freezing, storage, and transport using controlled cryogenic systems.

Patient-specific manufacturing

Supporting autologous therapies that require individualized production workflows.

Process monitoring and quality control

Ensuring sterility, potency, and consistency throughout the manufacturing process.

Viral vector production

Manufacturing viral vectors reliably and at sufficient scale to support gene therapy programs.

Hybrid manufacturing. Combining stainless and single-use systems.

Cell and gene therapy facilities often require highly flexible manufacturing environments capable of adapting to evolving process requirements. Hybrid production platforms combine stainless-steel infrastructure with single-use technologies to achieve both operational flexibility and long-term scalability.

Single-use technologies support rapid changeovers and reduced cleaning requirements, while stainless-steel systems provide durability and stability for core process infrastructure.

By integrating these technologies within modular process environments, manufacturers can establish facilities that support clinical development today while enabling expansion to commercial production in the future.

Detail from skid, consisting from piöes, hoses, valves

Process Integration for Gene Therapy Production

Seamless incorporation of single-use equipment allows maximum flexibility.

Modular, mobile equipment assemblies – including single-use bioreactors, detergent treatment units, chromatography, and filtration systems – ready for multiproduct manufacturing.

Person in cleanroom clothing in production area, mobile skids connected with hoses to the ceiling

Combining Stainless Steel and Single-Use

Integrated automation supporting flexible hybrid manufacturing environments.

ZETA integrated stainless-steel preparation systems and mobile single-use filtration units into a unified Siemens PCS7 control architecture, supporting flexible, GMP-compliant biopharmaceutical production.

Automation and process control. For advanced therapy manufacturing.

Automation plays a critical role in ensuring consistent and reproducible manufacturing of cell and gene therapies. Advanced process control systems enable operators to monitor key parameters, maintain stable process conditions, and ensure traceability throughout production. Digital process control improves reliability while supporting regulatory requirements for advanced therapy manufacturing.

Integrated automation platforms support:

Process monitoring and data capture

Batch documentation and compliance

Environmental monitoring

Equipment integration across production suites

Building Flexible Manufacturing Environments for Advanced Therapies

Learn how ZETA supports cell and gene therapy manufacturing with integrated process systems designed for scalability, process control, and evolving production requirements.

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