Virtual Pharma Expo 2024: Fill-Finish Configurations for Cell & Gene Therapies

AST vice president of sales and marketing Josh Russell demonstrating the use of the GENiSYS R robotic line for aseptic fill finish manufacturing
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Josh Russell, AST’s Vice President of Sales and Marketing, recently took part in the Virtual Pharma Expo: Aseptic Fill/Finish, Manufacturing and Packaging with a walkthrough of some of the latest AST technology, demonstrated on our GENiSYS® R robotic line. 

This year, AST wanted to provide an exciting look from our manufacturing facility located in Washington State, where we design, build, assemble, and test our aseptic processing systems. The facility also serves as our research and development hub, where the AST technical team conceptualizes and brings to life the latest AST advancements and the next iterations of our aseptic fill-finish technologies. Josh presents an exclusive look at a GENiSYS R system currently being built and prepared for FAT and provides an on-the-ground perspective on how AST designs our solutions for flexibility and efficiency.

One of the ways we achieve this is by offering solutions that are configurable to our customers’ container and process needs. Lead time is crucial, and the cost and delay often associated with fill line customization are not tenable for manufacturers looking to stay on budget and on time. Josh provides insight into how we utilize highly adaptable systems to meet the majority of customer applications through proven scalable technology and modular layouts. Here are some highlights of key solutions and advancements demonstrated on this GENiSYS R line: 

Solution: Semi-automated bag opening allows for operator-prompted debagging and no-touch transfer to the MTO. Once in the MTO and received by an adjustable conveyor, the operator peels and disposes of the lid and liner, and using a touch button, indexes the tub or tray into to the Fill-Close Module.

  • Advancement: Automated processing of the West’s Daikyo Crystal Zenith® tray pack. One of the challenges of processing tray packs is that they are pliable and can be difficult to handle. The vials are also typically compacted and close together, and their material makeup makes them prone to tipping during processing. Common challenges include inverting the vials in such a way that they can be processed successfully, without scratching or bruising the vial during processing.

This GENiSYS R system uses robotic tooling to invert the vial and transfer it to a custom fixture on the centering plate, where a container transfer robot commences filling the vials.

Solution: High yield, fully traceable fill operation, utilizing a two-head filler where product fill occurs on a gravimetric balance. This real-time in-process weigh check (IPC) enables complete stewardship of highly targeted, high-value drug products like cell and gene therapies. Fill operations are primed and calibrated on the weigh cell for a zero-waste approach.

  • Advancement: The AST Pump. Highlighted here are two AST peristaltic pumps, a user-friendly solution specifically designed for isolator barrier installation. A single-operating door can be easily opened using a pull knob. The operator can thread the fluid pathway/peristaltic tubing, secure it, and close the door. Featuring an ergonomic design, installation can be completed one-handed through a glove port.  

Solution: Machine intelligence with end-to-end visual and sensor verification points. AST’s line of GENiSYS fill-finish systems utilizes a comprehensive suite of visual and sensor checks across critical points in the fill, close, and capping process to ensure product integrity and as-needed reject handling.

  • Advancement: The GENiSYS R features re-stoppering functionality where visual systems will detect a missing stopper or a stopper not properly seated and reapply in order to close the vial successfully.  This system also utilizes enhanced error detection for tumbled containers and collisions.  

Optimal Configuration: Minimizing Run Time, Maximizing Yield for Cell & Gene Therapies

Cell and gene therapies require complete product stewardship to get to patients successfully, and this requires considerations for yield, product exposure, and overall processing time.  The GENiSYS R system demonstrated here, configured to process a gene therapy product, implements a “first in, first out” principle. This approach is crucial to product integrity and minimizes the overall processing time.

Process efficiencies in the Fill Close Module (FCM) are crucial. The fill and close positions operate by a tight two-by-two sequence, minimizing product exposure to the greatest extent possible. Engineered enhancements like simultaneous IPC and stoppering minimize throughput disruptions and, thus, the overall time a vial stays in the machine.  Modular layout is also a key consideration: a linear configuration of the Vial Sealing Module allows vials to be capped and exit in the order they were filled and get to their final destination, the patient, as quickly as possible.

The GENiSYS R is a fully integrated turnkey solution. Check out the full demonstration above and contact our experts today!