3rd Generation Closed Filling System
- Invetech Pty Ltd
Invetech’s 3rd Generation Closed Filling System for Cell and Gene Therapy provides robust, cost-effective, ‘Good Manufacturing Practice’ (GMP)-based commercial manufacturing systems for life-saving treatments such as Chimeric Antigen Receptor T-Cell (CAR-T) therapy.
Cell therapies have traditionally been difficult and costly to produce as the entire manufacturing process must be kept in a sterile environment to avoid contamination of the cell product. Consequently, most cell therapy products have been manufactured by hand, using skilled technicians in high-grade cleanrooms, resulting in limited scalability. Invetech’s System delivers a robust, scalable, cost-effective solution for a critical element of this manufacturing pathway.
Invetech’s modern monolithic design language uses a monocoque stainless chassis and centralises the operator through Human-Machine-Interface (HMI) placement, streamlined left-to-right process flow and ‘everything visible and within reach’. The form encapsulates the critical performance functionality of the system, while accentuating differentiating secondary characteristics – robustness, ease-of-use and cleanability. Active end-user integration throughout the design process has delivered an intuitive, orchestrated system supporting the operator throughout processing. Visual HMI guidance creates an easy-to-follow sequence for the operator, with staged system checks providing confidence in process control. Operator contact opportunity with biological process fluids is eliminated through isolation in single-use disposables.
Invetech’s system enables the world’s leading biopharmaceutical companies to produce the next generation of life-saving therapies to treat terminal illnesses including relapsed, refractory cancers and autoimmune diseases.
Currently, most cell therapy products are manufactured by hand, with high failure rates and significant embedded costs in a process that doesn’t scale. Invetech’s system allows manufacturers to safely produce and scale their operations to maximise usage of scarce skilled resources. Typically, Invetech’s system increases dose production by a factor of 100 to 1,000 times existing dose output p.a. and reduces batch production man-hours from 144 hours/batch to less than 8 hours/batch.
The form of Invetech’s 3rd Generation Closed Filling System is revolutionary in the industrial bioprocessing industry, where traditional equipment remains convoluted and complex, showing little consideration of form and design beyond basic functionality. Through considered design, form and functionality of the system, it represents outstanding value to bio-pharmaceutical manufacturers engaged in commercial production of cell and gene therapies. Value typically derives from reduction in skilled labour requirements, increase in throughput, lower process variability, higher yield, and reduction of high-grade clean-room footprint. The system has been designed and manufactured in Melbourne, Australia and is exported to the world’s leading biotherapeutics companies.
Invetech’s 3rd Generation Closed Filling System represents a step-change advance from previous generations. The system is modular, enabling configuration to the process requirements of our clients. It is integrated – the equipment, the single-use disposable, the industrial controls and data management together provide seamless process automation. Two world-first features drive value through simplification of the operator interface. Firstly, drop-in disposable loading enabled by frontloading pinch-valves and rigid spars simplifying disposable handling, eliminates a common industry problem of intricate and failure-prone tubeset loading. Secondly, a traversing heat-sealing head sequentially seals and separates output bags, removing repetitive manual tasks and key failure modes.
Invetech’s 3rd Generation Closed Filling System is a compact filling system that can be managed by a single operator and utilising closed disposables for all fluid contact surfaces to enable low-grade cleanroom operations. It has a standardised system architecture, highly configurable to meet specific manufacturing needs including throughput, batch size, fill volume, contact materials, controls interface and temperature control. It is a robust industrial solution, intended for 24/7 operations over a 10+ year lifespan. It minimizes human workload through intelligent design, while embodying effective control and governance, and has a clean, minimalist, safe and functional design.