[Quality control methods and requirements for recombinant human lymphocyte function associated antigen 3 IgG1 fusion protein (rhLFA3-IgG1)].
To establish methods and requirements for quality control of rhLFA3-IgG1, biological potency of rhLFA3-IgG1 was determined by CD2 molecule competitive binding assay on Jurkat cell surface. Purity of rhLFA3-IgG1 was analyzed by SEC-HPLC and IEC-HPLC. Peptide mapping was preformed by tryptic digestion and RP-HPLC after sample reduced and carboxymethylation by DTT and indoacetic acid, respectively. CHO host cell protein and Protein A residual were detected by ELISA separately. The quality control methods and requirements, such as biological potency, the physical-chemical characteristic of rhLFA3-IgG1 had been established. The methods and requirements for quality control of rhLFA3-IgG1 showed advantages of assuring the products safety and efficacy, which can be used for routine quality control of rhLFA3-IgG1.
Gao
Kai
K
National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China.
Han
Chun-mei
CM
Ding
You-xue
YX
Hou
Sheng
S
Rao
Chun-ming
CM
Wang
Jun-zhi
JZ
D000077944:Alefacept; D001667:Binding, Competitive; D001709:Biotechnology / Q000379:methods*; D018801:CD2 Antigens / Q000378:metabolism; D018968:CD58 Antigens / Q000096:biosynthesis / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid; D006801:Humans; D007074:Immunoglobulin G / Q000096:biosynthesis / Q000737:chemistry; D019169:Jurkat Cells; D008970:Molecular Weight; D010449:Peptide Mapping; D011786:Quality Control; D011993:Recombinant Fusion Proteins / Q000096:biosynthesis* / Q000737:chemistry
D018801:CD2 Antigens; D018968:CD58 Antigens; D007074:Immunoglobulin G; D011993:Recombinant Fusion Proteins; D000077944:Alefacept