Invetech – 3rd Generation Closed Filling System

  • 2020

  • Engineering

Designed By:

  • Invetech Pty Ltd

Commissioned By:

Invetech Pty Ltd

Designed In:


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 (a new form of immunotherapy that uses specially altered T-cells to directly and precisely target cancer cells).

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  • 1. Design a robust, scalable, cost-effective system for closed filling of critical process fluids within GMP biopharmaceutical manufacturing principles. 2. Create a closed filling solution designed to minimize cleanroom specifications. 3. Allow for a configurable batch size/number of bags/fill volume to enable flexible manufacturing across cell product, master and working cell banks, viral vector, and media. 4. Allow for batch processing that can occur within a single shift, with a single operator. 5. Design for global 24x7 operations of high-volume manufacturing for commercial therapies. 6. Create data management processes for everything from standalone operations to fully integrated solutions.

  • The project met all of the following key aspects of the design brief; 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. A standardised system architecture, highly configurable to meet specific manufacturing needs including throughput, batch size, fill volume, contact materials, controls interface and temperature control. A system that has high-throughput whilst still allowing for ease of operator use, particularly with regard to integrating automated ‘seal and separate’ processes to eliminate manual sealing – previously a significant operator injury risk through RSI.

  • Invetech’s 3rd Generation Closed Filling System enables the world’s leading biopharmaceutical companies to produce the next generation of life-saving therapies including CAR-T. These cell therapies are emerging as the next generation of medicine, demonstrating near-curative potential for previously 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 and to protect those resources from repetitive strain injuries.

  • 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 3rd Generation Closed Filling System delivers a robust, scalable, cost-effective solution for a critical element of this manufacturing pathway. 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. This is achieved through; • Being a robust industrial solution, intended for 24/7 operations over a 10+ year lifespan. • Minimizing human workload through intelligent design, while embodying effective control and governance. • Being clean, minimalist, safe and functional. • Having a modular design that enables configuration for broader, effective field of use and rapid maintenance. • Closed disposables. • High-precision fluidic control for accurately metered volumes and minimal loss. • Being easy to qualify, validate, maintain and operate. • Automated air-management, disposable integrity testing, filling, operator interactions, seal and separate, disposable set loading and unloading. • Ability to operate standalone, or fully integrated into data and control infrastructures.