Recombinant Human Growth hormone (hGH)
A DNA sequence encoding the mature hGH protein was expressed in P. Pastoris
0.2 μm-filtered solution in 20mM glycine, 200mM Mannitol, 20mM NaH2PO4 , pH 7.4; m-cresol 2mg/ml, glycerol 4 mg/ml
Protein concentration per 1ml:
3.3 mg ±4%
|Release Testing:||Specification||Lot Result|
|Specific Activity||3.4 IU/mg||3.0-5 IU/mg|
|Endotoxin level:||<20 EU/mg||<10 EU/mg|
|Host-cell DNA:||≤ 200ng/mg||Complies (1.1ng/mg)|
Activity was determined using a Nb2-11 cell proliferation assay
Purity was determined by SDS PAGE and coomassie stain (under reducing and non-reducing conditions). Identity was confirmed by end-of-production DNA sequencing and N-terminal protein sequencing. Sterility test of vialed product was performed according to Eur.Pharm. (Inoculation method).
Endotoxin was determined using the gel clot assay according to Eur.Pharm.
Host-cell DNA was determined using fluorimetric assay.