Solutions for CAR-T cell therapy

A modular cluster integrating robotic handling, GMP instruments, compatible sterilization functions and digital process orchestration. Automated loading, unloading, transfer, connection and sample-handling activities reduce exposure and manual variability while multiple operations run in parallel. Complete process-data capture supports patient-specific traceability and quality review; additional clusters expand capacity through scale-out without fundamentally redesigning the validated manufacturing model.

Configurable washing supports controlled treatment of laboratory glassware, reusable utensils and compatible components used in CAR-T quality-control and process-development activities. Adaptable cycles and load arrangements allow different laboratory materials to be processed with repeatable parameters and documented execution, without presenting the washer as part of the robotic manufacturing cluster.

A compact, configurable platform for high-temperature treatment of culture media, laboratory glassware, instruments, compatible components and, where required, laboratory waste. Configurable cycles, controlled parameters and documented execution support changing small-batch requirements in QC and process-development laboratories while remaining clearly separate from the core robotic manufacturing flow.

In laboratories handling biologically hazardous materials, microbial inactivation is only part of the challenge.

Before treatment is complete, contaminated air, aerosols, liquids and condensate can create potential exposure pathways for operators, the facility and the surrounding environment. The process must therefore do more than deliver the required thermal treatment. It must contain every potentially contaminated output and prevent its release until the cycle has been successfully completed.

A pre-filled syringe is a hermetically sealed container with a movable plunger. During thermal sterilization, the liquid expands, part of it vaporizes, dissolved gases are released and the gas already present in the headspace increases in pressure.
An aqueous solution expands by approximately 6% when heated from ambient temperature to 121°C, while the volume of a glass syringe increases by only about 1%.

The rapid growth of biologics, nanoparticle-based medicines and Advanced Therapy Medicinal Products (ATMPs) is redefining the relationship between pharmaceutical formulations and primary packaging.
Interactions between proteins such as insulin, nanoparticles and container surfaces are well-recognised phenomena that can influence product stability, efficacy and patient safety. As these therapies become increasingly sensitive, material compatibility can no longer be considered an intrinsic property of the container alone.

When manufacturers seek to move away from EtO towards a method that reduces toxic-residue concerns and the potential burden on patients, workers and the environment, selecting an alternative sterilant is only the beginning.
This is particularly true for the low-temperature sterilization of RTU glass vials in their complete packaging configuration. The sterilant must pass through the outer transport box, multiple porous barriers and enclosed packaging interfaces before reaching the internal vial surfaces. The same structure must then release residual sterilant within an acceptable aeration time.