Tacoma, WA - AST, a leading provider of flexible aseptic filling systems, announces they are now offering delivery of their most popular isolated equipment within 6 months of purchase. This is a dramatic improvement over typical industry delivery times, which are often up to 24 months. AST knows that time to market is critical in delivering drug products to sick patients, and quick delivery demonstrates their commitment to reducing the time it takes to provide critical treatments.
With this announcement, the systems available for this quick-delivery program are AST’s GENiSYS® R and GENiSYS Lab benchtop systems, both integrated with an isolator. Each system is designed to meet strict regulatory requirements for injectable drug products.
The isolated GENiSYS Lab product line includes the Container Filling System (CFS), Container Closing System (CCS), and Vial Sealing System (VSS), which automate the critical aseptic operations for container processing. With advanced features and reporting capabilities, isolated GENiSYS Lab machines are ideal for production of Advanced Therapeutic Medicinal Products (ATMP), such as cell and gene therapies.
AST’s GENiSYS R is a robotic filling and closing system for small batch aseptic production applications. It has the flexibility to process vials, syringes, and cartridges on a single machine platform. The design provides unrivaled capabilities for customers requiring flexibility to process multiple product and container types on a single machine. The quick-delivery option includes semi-automatic bag opening, manual tub opening, robotic filling and closing, and automatic vial sealing. Additional system features include in-process weigh checks (IPC), an Electronic Batch Records (EBR) system and the ability to process any commercially available nested Ready-to-Use (RTU) container.
In 2022, AST proved their ability to fast-track machine delivery by supplying a quick-delivery GENiSYS R system to a major worldwide CDMO. This ability to deliver fill-finish equipment within 6 months of purchase order provides significant business advantages, allowing for shortened production schedules and more quickly realized return on investment. “AST is a company that is continually trying to push the accepted boundaries of the fill-finish industry. During the pandemic we witnessed the urgency of getting critical treatments to patients in need. Our quick-delivery GENiSYS R & GENiSYS Lab system options will provide a significant advantage to our customers, but more importantly it will directly impact the patients whose lives depend on receiving medications as quickly and safely as possible,” said Joe Hoff, AST president and CEO.
AST is a privately held U.S. based company that revolutionized the cGMP aseptic small batch fill-finish industry. Using robotics and advanced automation, the ASEPTiCell® was the industry's first multiformat cGMP aseptic fill-finish machine capable of processing ready-to-use vials, syringes and cartridges using a single machine. Today AST is recognized as an industry leader in flexible aseptic filling, offering an extensive range of products that support drug product development, clinical and commercial needs using their GENiSYS® Lab, GENiSYS C, GENiSYS R, and ASEPTiCell product lines.