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

Proteintech Group, Inc, the benchmark in antibodies and proteins, announces completion of its ISO 13485 certification for medical devices.

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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 ...

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