SUCCESS STORY

CGT production: Easy scalability thanks to robotics

In pharmaceuticals, the transition from laboratory to production scale is always a challenge. Scaling is particularly complex for cell and gene therapies (CGT). In a system platform for sterile filling of CGT drugs, two Stäubli TX2-60 Stericlean robots perform flexible handling of different dosing formats.

CUSTOMER BENEFITS

Flexible handling of different dosing formats
Stable and safe filling process
Compliance with the highest purity standards
Use of one system for different CGTs

TASK

Flexible processing of vials, syringes, and IV bags

Cell and gene therapies (CGTs) represent a milestone in the pharmaceutical industry. However, the production of large quantities is a real challenge. Automation provides opportunities to increase production and ensure quality while reducing both costs and risks in the process.

BAUSCH Advanced Technology Group (BATG) develops and manufactures automated aseptic fill-finish equipment. It is a leader in the life science market with locations in the U.S., Germany and Brazil. BATG’s latest solution streamlines the CGT manufacturing process and paves the way for reliable scaling.

In addition to increasing production volumes and adhering to strict aseptic conditions, versatility was a key factor. Because the production of CGT therapies requires smaller batch sizes, BATG developed a system that can process CGTs in multiple dosage formats seamlessly and – for reasons of cost efficiency and extremely high purity requirements – do so completely automatically.

SOLUTION

Robotics enables the technological leap

The modular Vers-A-Tech™ platform enables aseptic filling and closing of vials and syringes as well as infusion bags on a single machine. This includes loading, unpacking and uncapping, surface decontamination, filling and capping, lyophilization, crimping and ejection – all with 100% in-line process control.

At the heart of the system platform is a Stäubli TX2-60 Stericlean robot designed to operate in a GMP Class A environment and handle various types of containers in isolators without the risk of contamination. The new system fills and seals nested vials, syringes, and infusion bags at a rate of up to 20 containers and up to five infusion bags per minute.

Two TX2-60 Stericlean units perform most of the handling tasks in the fill-finish process, from transporting the still empty containers for decontamination, separating them before filling, and positioning and sealing the containers to transporting the nested containers to the freeze dryer. If infusion bags are filled instead of syringes or vials, the robots adapt automatically.

At the heart of the Vers-A-Tech platform are Stäubli TX2-60 Stericlean robots designed to operate in a GMP Class A environment.

The Stäubli TX2-60 Stericlean stands out with its high cleanroom classification, dynamics and precision.

The modular Vers-A-Tech platform adapts to various requirements: Syringes and vials as well as IV bags can be filled in a process-safe, sterile and highly productive manner.

CUSTOMER USAGE

Flexible solution enables easy scalability

With the Stäubli TX2-60 Stericlean robots, Vers-A-Tech can fill and finish up to 1,200 nested vials or syringes per hour and up to 300 infusion bags per hour. As companies add new CGTs to their portfolios, the flexible design of the system and the adaptability of Stäubli robots enable Vers-A-Tech to fill the required quantities as well as the desired dosage forms.

This will allow users to quickly enter more segments of the expanding CGT market. Dozens of new CGTs holding the promise of more effective treatments for cancer and other serious diseases will be hitting the market in the next few years. Their success will depend on production lines that can reliably deliver higher volumes and meet stringent regulatory standards.