CDMO QCL Expands Fill Finish Capabilities

Automated Systems of Tacoma (AST), a provider of flexible aseptic filling systems, and Quality Chemical Laboratories (QCL), a contract development and manufacturing organization (CDMO), have formed a 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, NC

facility as they expand and diversify into the parenteral CDMO space.

QCL, a provider of contract analytical chemistry, microbiology, organic synthesis, and clinical stage oral product development and manufacturing services, says it is leveraging their experience to expand their business into a top tier CDMO of parenteral products.

“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,” said Yousry Sayed, founder, president and chief executive officer, QCL. “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. 

Joe Hoff, president and chief executive officer, AST, said, “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.”