Industry-First Solution Revolutionizes CGT Sterile Processing

As cell and gene therapies (CGT) rapidly expand, there is a growing need for more efficient sterile processing techniques. To provide CGT manufacturers with alternatives to using cumbersome biosafety cabinets or tube welding to maintain sterility, CPC (Colder Products Company) introduces the smallest aseptic connector available. The innovative MicroCNX® Nano Series connectors help maintain sterility in CGT processes using 1/8- or 1/16-inch tubing and launches today at the Advanced Therapies Week meeting in Dallas.
Cell therapy and gene therapy are advancing quickly, but the industry has had to rely on older techniques like biosafety cabinets or tube welding for sterile processing,” said Troy Ostreng, senior product manager for CPC’s biopharmaceutical business. “Now, CGT processing assemblies that include the MicroCNX Nano connector allow users to easily click together the connector halves to create a sterile flow path. It is a major advancement for CGT applications."
CGT manufacturers rely on 1/8-inch and 1/16-inch flow paths to move cells efficiently, with minimal turbulence, and to help reduce holdup volume, so the connection method needs to contribute to these goals. Tube welding requires extra tubing on either side of the weld, which is a source of holdup volume.
Welding 1/16-inch tubes together also requires time-consuming precision to ensure the tubing’s flow path remains open after clamping and heat application. Any offset of the tubing at the weld point can lead to leakage and/or contamination risk. In contrast, the Nano Series does not require extra tubing, and the connectors can be quickly joined outside of a biosafety cabinet.
“Just like single-use technologies have significantly advanced biopharmaceutical processing, we believe small-format aseptic connectors are the future of CGT sterile processing,” said Ostreng. “MicroCNX Series products offer a faster, more efficient approach to creating sterile closed systems.”
The Nano connector’s small size also allows it to fit directly into the freeze cassettes used in CGT product cryopreservation. The connectors can be frozen to -190°C, which supports cell health during storage and transport.
The new product’s termination and flow path are made from polyphenylsulfone (PPSU), a high- performance polymer that is chemically compatible with harsh chemicals used in cryopreservation like dimethyl sulfoxide (DMSO).
Like earlier MicroCNX products, the MicroCNX Nano Series is compatible with tubing types that are commonly used in developing advanced therapies including silicone, thermoplastic elastomer (TPE), and polyvinyl chloride (PVC).
For more information about the performance and versatility of the MicroCNX Nano Series connectors or any of the other innovative connection solutions CPC offers, visit booth #215 or cpcworldwide.com/MicroCNX
About CPC Biopharma
CPC (Colder Products Company) is the leader in single-use connection technology, offering a wide variety of connectors for manufacturing in biopharmaceuticals, cell therapy, and gene therapy. The company’s innovative, flexible products enable users to easily combine multiple components and systems including process containers, tubing manifolds, transfer lines, bioreactors and other bioprocess equipment. Robust single-use connectors maintain media sterility and integrity while improving production yields, decreasing time to market and reducing costs. The company’s well-known AseptiQuik® connectors provide quick and easy sterile connections even in non-sterile environments. Learn more at cpcworldwide.com/bio. Connect with confidence with CPC, an operating company within Dover Corporation.