cGMP Grade Cytokines & Growth Factors

Proteintech is ISO13485 certified and our cGMP Policy ensures:

  • Raw material qualification, documentation and traceability

  • Regular check and qualification of clean rooms and instruments

  • Validated process and standard operating procedures

  • Well defined standards and In Process Quality Check (IPQC)

  • Systematic and organized training program for personnel

  • Deviations and Corrective Action Preventive Action (CAPA)

ISO13485 seal

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® cGMP (current Good Manufacturing Practice) recombinant proteins are manufactured and validated in accordance with ISO 13485 quality management system and is compliant with cGMP.

HumanKine® cGMP recombinant proteins offer safety, purity, stability, and potency to use in ex vivo manufacturing processes, as defined in USP (United States Pharmacopeia) Chapter 1043 Ancillary Materials for Cell, Gene, and Tissue-Engineered Products, Growth Factors and Cytokines Used in Cell Therapy Manufacturing, WHO TRS, No. 822, 1992 Annex 1 Good Manufacturing Practices for Biological Products.

cGMP Grade Cytokines and Growth Factors

All HumanKine cytokines and growth factors are expressed in HEK293 cells.

Product Activity (EC50) Purity
Activin A 0.5-3.5 ng/mL  >95%
BMP-2 7.5-37.5 ng/mL >95%
BMP-4 1.5-9 ng/mL  >95%
Cystatin C 0.5-2.6 µg/mL >95%
FGFbasic-TS 0.07-0.4 ng/mL >95%
FLT3 Ligand 0.4-3.0 ng/mL >95%
G-CSF 0.009-0.05 ng/mL >95%
GM-CSF 0.08-0.8 ng/mL >95%
HSA N/A >95%
IFN gamma 0.02-0.14 ng/mL >95%
IGF-I 2-14 ng/mL >95%
IL-2 0.05-0.35 ng/mL >95%
IL-3 0.4-2.0 ng/mL >95%
IL-4 0.07-0.4 ng/mL >95%
IL-10 0.18-2.0 ng/mL >95%
IL-12 1-5 ng/mL >95%
IL-15 3-17 ng/mL >95%
IL-28A 0.01-0.06 ng/mL >95%
M-CSF 0.7-4.0 ng/mL >95%
Noggin 3-15 ng/mL  >95%
PDGFbb 0.3-3 ng/mL >95%
TGF beta 2 0.018-0.18 ng/mL >95%
TGF beta 3 0.15-0.75 ng/mL >95%
TNF alpha 0.002-0.026 ng/mL >95%
VEGF165 0.3-3.75 ng/mL >95%
Wnt3A 25-125 ng/mL >90%

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Proteintech's cGMP Facility in Chicago, IL
Proteintech's gmp compliant laboratory