ISO 13485 certification announcement - GMP compliant proteins

Proteintech announces ISO 13485 Certification for Its HumanKine® Human Cell-expressed Cytokines and Growth Factors

ROSEMONT, IL [06/01/20] – Proteintech Group, Inc, the benchmark in antibodies and proteins, announces completion of its ISO 13485 certification for medical devices.

With  this certification, Proteintech’s HumanKine® Human cell-expressed cytokines and growth factors are now available in GMP-compliant versions for use in clinical trials and commercial manufacturing. 

Cytokines and growth factors are critical components to cell and gene therapies. Unlike traditional pharmacologics, cell and gene therapies require the expansion and maintenance of living cells. Cytokines and growth factors coordinate and sustain these processes.

With the rise in clinical trials, there is not only a greater demand for GMP-compliant proteins, but also a demand for safer and more active proteins. Besides being xeno-free and free of animal-derived components, Proteintech’s HumanKine® Human cell-expressed proteins are produced with native folding, glycosylation, and processing. These properties result in higher efficacy and stability than proteins produced using other systems.

Jeff Lee, Chief Operating Officer at Proteintech, said, “It is exciting to have our certification completed in less than 10 months after opening.   The timing is great, as it aligns with the completion of several of our product validations.”

Deepa Shankar, Chief Scientific Officer at Proteintech, commented, The advances in cell and gene therapy and regenerative medicine have been astounding. As these therapies scale up, the need for quality reagents is more significant than ever. By investing in a new GMP facility and the quality systems to ensure GMP-compliance and ISO 13485 certification, we at Proteintech aim to meet this demand with our suite of GMP grade Human-expressed, well-characterized bioactive proteins.”

Proteintech has launched four GMP grade cytokines and has many more planned for launch later this year. To find out more about these cytokines and to browse other products click here.

ISO 13485 completion certificate for Proteintech Group, Rosemont Illinois.