These properties result in higher efficacy and stability than proteins produced using other systems.
#Iso 13485 gmp free
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. 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. Cytokines and growth factors coordinate and sustain these processes. Unlike traditional pharmacologics, cell and gene therapies require the expansion and maintenance of living cells. With t his 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.Ĭytokines and growth factors are critical components to cell and gene therapies.
#Iso 13485 gmp iso
ROSEMONT, IL – Proteintech Group, Inc, the benchmark in antibodies and proteins, announces completion of its ISO 13485 certification for medical devices. Proteintech announces ISO 13485 Certification for Its HumanKine® Human Cell-expressed Cytokines and Growth Factors
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We have associates and offices around the world and our consultants are knowledgeable about various markets. (Choosing the same registrar (certification body) for ISO 13485 Certification and CE Marking will help you avoid two separate audits).
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A requirement of CE mark and for the permission to sell medical devices in the European Union.Achieving compliance with European regulatory requirements.
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