Automated Systems of Tacoma, LLC (AST), a leading provider of flexible aseptic filling systems, and Quality Chemical Laboratories, LLC (QCL), a Contract Development and Manufacturing Organization (CDMO) announce their partnership on two multi-format filling and closing machines for use in cGMP aseptic small batch processing. QCL has purchased a GENiSYS R robotic filling and closing system with auto loading/unloading lyophilizer integration, and a GENiSYS® C semi-automated filling and closing system, both to be installed at their new 90,000 ft2 Wilmington, North Carolina facility as they expand and diversify into the parenteral CDMO space.
QCL, already an established leader in contract analytical chemistry, microbiology, organic synthesis, and clinical stage oral product development and manufacturing services, is leveraging their ongoing success and excellent customer relationships to expand their business into a top tier CDMO of parenteral products. Dr. Yousry Sayed, Founder, President and CEO of QCL, stated, “The GENiSYS C and GENiSYS R will allow us to serve our clients by enabling us to provide services from testing and validation through manufacturing all on the same campus. We are excited about the flexibility and quality these systems will provide to us to enable QCL to expand our capacity to fulfill a wide variety of customer projects.”
QCL’s flagship filling line, the GENiSYS R, is a robotic filling and closing platform for small batch aseptic applications, with the flexibility to process vials, syringes and cartridges on a single platform. The design provides unrivaled capabilities for customers needing flexibility in small-batch aseptic processing. QCL’s GENiSYS R will be configured with fully automatic bag/tub opening, filling/closing, vial sealing and lyophilizer integration with automatic loading/unloading.
The GENiSYS C filling and closing system is a flexible and compact footprint capable of processing all nested vial, syringe and cartridge formats on a single machine. QCL’s GENiSYS C will be configured with semi-automatic bag/tub opening, and automatic filling/closing and vial sealing.
Both systems are configured with aseptic isolator barriers, innovative IPC weigh check systems, and EBR systems offering robust and reliable data systems to meet QCL’s customer needs for both cGMP and data integrity compliance.
Quality Chemical Laboratories sought out an isolated, robotic system as their flagship filling line after surveying regulatory recommendations and industry trends. Both the GENiSYS C and GENiSYS R will give QCL the flexibility to fulfill a wide range of projects and provide the sterility assurance their customers’ products require. "The entire team at AST is excited to partner with QCL in their expansion, and grateful to showcase our GENiSYS platforms in their beautiful new facility! We look forward to supporting Quality Chemical Laboratories 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 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 Quality Chemical Laboratories
QCL is a privately owned Contract Development and Manufacturing Organization founded by Dr. Yousry Sayed in 1998 with an original mission as a contract lab with expertise in raw material and compendial testing. Continuously led by Dr. Sayed, QCL has grown organically to encompass finished product testing and product development for both small and large molecules. Our sweet spot is pre-formulation, product development, and getting clinical trial materials to the clinic on aggressive timelines. We provide all the analytical development and validation, execution of stability studies, and testing of APIs, Finished Products, and Raw Materials.
QCL currently employs over 240 people within a 90,000 ft², six-building “campus” maintaining a single FDA registration and multi-disciplinary DEA registrations. Greenfield construction with contiguous build-out expansion will double QCL’s current footprint to 180,000 ft2 by Q1 2022 and broaden our services to late phase clinical and commercial GMP manufacturing including state of the art parenteral manufacturing as well as additional testing capacity. For more information, visit www.qualitychemlabs.com