cGMP Grade Cytokines & Growth Factors
The demand for Autologous and Allogeneic cell therapy is rapidly growing, thereby increasing the need for high quality raw material that can ensure maximum patient safety.
Proteintech GMP grade HumanKine growth factors and cytokines are produced in human cells, ensuring the right post-translational modifications required for the highest bioactivity. Our entire line of HumanKine products is exclusively manufactured using a human expression system, in accordance with USP and WHO standards, ensuring maximum safety and reproducibility.
Raw material qualification
Quality check at every step of production
Animal component free and Xeno free production process
ISO rated clean rooms for manufacturing and filling
Regulatory support and Facilitiy available for on site audit
cGMP Grade Cytokines and Growth Factors
All HumanKine cytokines and growth factors are expressed in HEK293 cells.
|Product||Activity (EC 50)||Purity|
|Activin A||0.5-3.5 ng/mL||>95%|
|Cystatin C||0.5-2.6 µg/mL||>95%|
|FGF-7 (KGF)||4-20 ng/mL||>95%|
|FLT3 Ligand||0.4-3.0 ng/mL||>95%|
|IFN alpha 2B||0.004-0.02 ng/mL||>95%|
|IFN beta||0.015-0.08 ng/mL||>95%|
|IFN gamma||0.02-0.14 ng/mL||>95%|
|TGF beta 1||0.01-0.17 ng/mL||>95%|
|TGF beta 2||0.018-0.18 ng/mL||>95%|
|TGF beta 3||0.15-0.75 ng/mL||>95%|
|Thrombin (Coagulation Factor II)||1000-5000 units/mg||>95%|
|TNF alpha||0.002-0.026 ng/mL||>95%|
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RUO vs GMP
To facilitate a seamless preclinical to clinical transition, we offer both RUO and GMP grade cytokines and growth factors. Both product grades are produced under the same conditions in a GMP facility, using identical production processes. The GMP grade products come with extensive documentation, as well as thorough QC testing and traceability, whereas our line of RUO grade products are more cost-effective during early research and development.
|Quality Management System: Manufactured, tested, released & distributed under ISO 13485||✔||✔|
|Adherence to GMP guidelines||✘||✔|
|Master cell bank fully characterized||✔||✔|
|All processes according to released SOPs||✔||✔|
|Change control, OOS and deviation procedures||✔||✔|
|Production and QC equipment qualified||✔||✔|
|Process validation by 3 consistency batches||✘||✔|
|Purity||> 95%||> 95%|
|Sterility testing USP<71>||✘||✔|
|Mycoplasma testing USP<63>||✘||✔|
|Endotoxin testing USP<85>||< 1.0 EU/µg||< 0.1 EU/µg|
|Validation of shelf life by accelerated and real-time testing||✔||✔|
|Identity of product confirmed||Two methods||Two methods|
|Supplier and raw material control||✔||✔|
|Activity value on CoA||EC50||EC50 and specific activity
(if NIBSC standard available)
|Regulatory support: DMF, on-site audits, change notifications, quality agreements etc.||✘||✔
|View all HumanKine products||View all GMP HumanKine products|
Animal component and Xeno free
GMP Lot-to-lot Consistency
Consistency in raw material features is critical for efficient manufacturing of cell based therapies. A well-defined manufacturing process of HumanKine growth factors ensures high lot -to-lot consistency in its identity, purity and bioactivity.
GMP BMP-4 (HZ-1045-GMP)
Figure 1: Three independent lots of GMP BMP-4 were tested for their ability to induce alkaline phosphatase production in ATDC5 (mouse chondrogenic) cells. The EC50 for this assay is 1.5-9 ng/mL. The activity of each lot is nearly identical. Each lot was also analyzed for purity on an SDS-polyacrylamide gel under reducing and non-reducing conditions.
GMP PDGFbb (HZ-1308-GMP)
Figure 2: Three independent lots of GMP PDGFbb were tested for their ability to induce the proliferation of NIH/3T3 (mouse fibroblasts) cells. The EC50 for this assay is 0.3-3.0 ng/mL. The activity of each lot is nearly identical. Each lot was also analyzed for purity on an SDS-polyacrylamide gel. This data demonstrates the lot-to-lot consistency of this protein.
Documents available on request
- Certificate of Analysis (COA)
- Certificate of origin (COO)
- Sterility certificate
- BSE/TSE statement
- Viral testing certificate for Master cell bank
- Drug Master Files- filing in progress.