[Study on methods for quality control of recombinant human neu epitope peptide 12].
OBJECTIVE
To establish methods and requirements for the quality control of recombinant human neu epitope peptide 12.


METHODS
Biological activity of recombinant human neu epitope peptide 12 was evaluated in FVB/N transgenic mice (TgN MMTV neu 202 Mul, Jackson Lab., USA) administered with samples. The percentage of antibody-positive mice detected by ELISA was used in the biological activity evaluation. The peptide map was performed by peptic digestion. The antigen content was determined by SEC-HPLC.


CONCLUSIONS
The quality control methods, such as biological activity, peptide map, antigen content, and the requirements for the quality control of recombinant human neu epitope peptide 12 were established. The established methods and requirements were already used for the quality control of recombinant human neu epitope peptide 12 products.
Ji
Hong
H
Beijing Municipal Institute of Drug Control, Beijing 100035, China.
Wang
Jun-zhi
JZ
Rao
Chun-ming
CM
Zhang
Yi
Y
Wang
Min
M
D000818:Animals; D000911:Antibodies, Monoclonal / Q000032:analysis; D001709:Biotechnology / Q000379:methods*; D000939:Epitopes / Q000032:analysis / Q000737:chemistry / Q000276:immunology; D005260:Female; D018734:Genes, erbB-2; D006801:Humans; D051379:Mice; D008807:Mice, Inbred BALB C; D008822:Mice, Transgenic; D010446:Peptide Fragments / Q000737:chemistry / Q000276:immunology; D010449:Peptide Mapping; D011786:Quality Control; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis / Q000737:chemistry / Q000276:immunology; D011993:Recombinant Fusion Proteins / Q000032:analysis / Q000737:chemistry / Q000276:immunology; D013678:Technology, Pharmaceutical / Q000592:standards
D000911:Antibodies, Monoclonal; D000939:Epitopes; D010446:Peptide Fragments; D018719:Erb-b2 Receptor Tyrosine Kinases; D011993:Recombinant Fusion Proteins