Automated Systems of Tacoma, LLC (AST), a leading provider of flexible aseptic filling systems, and Goodwin Biotechnology, Inc. (Goodwin), a Contract Development and Manufacturing Organization (CDMO) announce their partnership on a GENiSYS® C20 multi-format filling and closing machine for syringes, cartridges and vials. Goodwin has purchased a GENiSYS C20 and Vial Sealing Module system, capable of automated cGMP aseptic small batch processing, and will collaborate with AST on its installation at its Plantation, Florida facility.
AST’s GENiSYS C and VSM-20 is the ultimate “multi-format” filling and closing platform for small batch aseptic applications. The design provides unrivaled flexibility in a compact layout, with an intuitive and simple user interface. The GENiSYS C will allow Goodwin to process nested, ready-to-use vials, syringes and cartridges. The system is equipped with advanced features, including: peristaltic pumps with automatic line purge and pump calibration, integrated in-process weighing (IPC), environmental monitoring, and electronic batch record (EBR) reporting that can be used to create 21 CFR Part 11 compliant batch reports.
Karl Pinto, CEO of Goodwin Biotechnology, said, “At Goodwin, we pride ourselves on being able to provide our clients with a fully integrated service offering from process development to cGMP bulk drug manufacturing and aseptic fill and finish, all under one roof. While we continue to offer our specialized, semi-automated filling solutions, the fully automated and flexible AST GENiSYS C system will more than double our capacity and enable us to increase the batch sizes and formats we are able to deliver. This investment is another important step in our evolution from making clinical stage products into supporting commercial manufacturing of complex biologics for our valued client base.”
Goodwin is specially equipped to work with modern, complex biopharmaceutical products that require careful handling and smaller batch sizes. Goodwin’s laboratories assist with process development for scaling up production of new and exciting drug products, and provide cGMP fill and finish services in their ISO5 filling suite. "AST’s GENiSYS C and VSM-20 system is perfectly suited to automate cGMP aseptic small batch processing for modern drug products. AST is excited and grateful to partner with such an innovative partner on the installation of this GENiSYS C and VSM-20, and we look forward to supporting Goodwin and their customers as they bring important new drugs to market for years to come," said Joe Hoff, AST's President and CEO.
About Automated Systems of Tacoma, LLC
AST is a privately held company that revolutionized the cGMP aseptic small batch fill/finish industry with the ASEPTiCell over 10 years ago. Using robotics and advanced automation, the ASEPTiCell® was the industry's first robotic multi-format 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. For more information visit, www.ast-inc.com.
About Goodwin Biotechnology
Goodwin is a uniquely qualified and flexible, US‐based CDMO (contract development and manufacturing organization) that offers a Single Source SolutionTM to enhance the value of complex biopharmaceuticals for our clients. With over 28 years of experience as an independent integrated contract manufacturer, Goodwin has worked as a strategic partner with companies and institutions of all sizes. Based upon their impressive track record, Goodwin has received numerous industry awards that span from Frost & Sullivan’s Customer Value and Leadership Award for Best Practices in Mammalian Contract Manufacturing to the Biologics cGMP Manufacturer of the Year in 2018 by Global Health & Pharma News. For more information, visit https://www.goodwinbiotechnology.com/.