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In vitro recombinant protein production can be prone to variability due to various reasons ranging from quality of raw materials to inconsistency in the process. HumanKine® GMP (Good Manufacturing Practice) recombinant proteins are manufactured and validated in accordance with ISO 13485 quality management system and is compliant with GMP.
HumanKine® GMP recombinant proteins offer safety, purity, stability, and potency to use in ex vivo manufacturing processes, as defined in USP (United States Pharmacopeia) Chapter Ancillary Materials for Cell, Gene, and Tissue-Engineered Products, USP Chapter Growth Factors and Cytokines Used in Cell Therapy Manufacturing, WHO TRS, No. 822, 1992 Annex 1 Good Manufacturing Practices for Biological Products.
|ISO 13485 completion certificate for Proteintech Group, Rosemont, Illinois. April 2020|
Animal component free (ACF), xeno free (XF) and tag free (TF) policy
Driven by the desire for improved product consistency and safety of our products, we follow a strict animal component free (ACF), xeno free (XF) and tag free (TF) policy.
|Product name||Catalog number||Activity||Purity|
|Activin A||HZ-1138-GMP||0.5 - 3.5 ng/mL||> 95%|
|BMP-4||HZ-1045-GMP||1.5 - 9 ng mL||> 95%|
|Noggin||HZ-1118-GMP||3 - 15 ng/mL||> 95%|
|PDGF-bb||HZ-1308-GMP||0.5 - 3 ng/mL||> 95%|
In order to facilitate a smooth transition from preclinical to clinical, Humankine® offers a wide range of Research Use Only (RUO) and GMP grade recombinant proteins which are exclusively expressed and purified from HEK293 human cells. The RUO and GMP products are both manufactured using the same expression systems, production process and operating procedures in a GMP facility. This guarantees that there is no variability in the quality and performance of these products.
The key differentiator of our GMP products from RUO is that we adhere to a rigorous quality process that is ISO13485 certified and GMP compliant. The GMP grade products come with extensive documentation, thorough QC testing and traceability. The RUO grade offers reliable products which are more cost-effective during early research and development.