INTERPHEX 2026 is gearing up for an exciting annual assembly of the latest innovations across the Pharmaceutical and Biotechnology industries. This year, AST will be co-exhibiting with Marchesini Group following the announcement of their strategic partnership in December 2025. As part of the collaborative showcase at booth 2501, AST is offering an end-to-end demonstration of the latest-generation isolated GENiSYS® R.
The Javits Center, NYC, will once again serve as host to the latest and greatest in product and service advancements from the pharmaceutical industry, as stakeholders gather from around the globe to attend INTERPHEX 2026. This year, the AST Team is excited to present the GENiSYS R, a fully automated, robotic fill-close machine designed for cell and gene therapy production. Featuring the complete system and barrier technology in-booth, the GENISYS R is the latest iteration of innovative, flexible fill-finish for the full scope or RTU containers. Housed in the Atmos™ isolator, the solution offers manufacturers a turnkey solution that leverages time-to-market benefits like a unified control platform for accelerated FAT and start-up, and a low-concentration VPHP decontamination system that drastically reduces machine downtime.
With the ongoing growth of targeted manufacturing for cell and gene therapies and other biologics, there’s a new threshold of quality, precision, and planning required from sterile parenteral production. Beyond typical QA measures, every aspect of variability must be accounted for throughout the fill-finish process, along with a clear, comprehensive, and responsive contamination control strategy as outlined in the revised Annex 1.
The GENiSYS R addresses these needs by providing manufacturers with a tool that leverages end-to-end product stewardship using configurable, modular technology: a flexible line configuration that utilizes highly repeatable, proven technologies with demonstrated efficacy in meeting the high degree of variability and quality demanded by multi-product production. The booth exhibit will feature the isolated GENiSYS R, demonstrating the full filling and closing process. This is a complete fill-finish production system designed to be a turnkey solution within a traceable, cGMP manufacturing environment. As part of the recently announced strategic partnership between AST and the Marchesini Group, the GENiSYS R demo will be followed by a downstream processing demonstration at the Marchesini Group booth exhibit.
Product Features
- Optimized batch processing of up to 20 containers per minute
- End-to-end hands-free processing of trays and tubs
- Modular construction- AST’s exhibited GENiSYS R at INTERPHEX will feature the Automatic Bag Opener (ABO), Automatic Tub Opener (ATO), Fill-Close Module (FCM), and Vial Sealing Module (VSM)
- Multi-format flexibility, with minimal changeover time
- Closing method flexibility, including press-fit capping or syringe and cartridge closing methods (vacuum, vent tube, or combination stoppering)
- AST dispensing technology with servo-driven accuracy for the most precise filling operations. The system can feature peristaltic, rotary piston pump, or combination pump options.
- Lyo Prep and Lyo Transfer integration available
- The Vial Sealing Module can be equipped for linear or nested vial processing and has all the features necessary for Annex 1 compliance.
- Unified, user-friendly HMI platform for the fill-finish, decontamination, and isolator systems that creates and edits batch recipes, and generates secure electronic batch records that are 21 CFR Part 11 compliance-ready
Process Features:
- Minimal change parts, including no change part requirements in the ABO and ATO
- Aseptic robotic automation: GENiSYS R robots avoid all interaction with refuse areas and never drop below working height
- Real-time in-process weight checks occur directly on the weigh cell and simultaneously with stoppering for minimal compromise to machine speed.
- Optimized Lyo Integration: As a batch is parked for the Lyophilization process, the FCM and VSM can continue to process other batches with no interruptions in data recording.
- Aluminum crimp caps are sealed using a spinning disk to minimize particle generation and create an aesthetic, pharmaceutical-grade seal without scratching polymer vials.
- Product stewardship advancements with end-to-end sensor and visual system checks, including multi-point reject detection, misaligned vial detection, and restoppering functionality to ensure machine safety and batch integrity.
If you’re in New York City the week of April 21-23, be sure to drop by and get a first-hand look at AST’s latest technologies and solutions. You can also schedule a one-on-one, dedicated visit with our team here. We’ll see you in the Big Apple!
