With world-class analytical techniques, GenScript is proud to provide a wide range of analytical testing services to ensure product quality and consistency during all stages of drug discovery and development. GenScript's experts have expertise to take both recombinant proteins and monoclonal antibodies, from research and product development through characterization and quality control tests. Services are available for both standalone analytical assays and broad testing programs, to meet your specific needs.
Analytical services | Analysis target | Available method |
---|---|---|
Identification & characterization | Protein identification | Western Blot |
Molecular weight | LC-MS; MALDI-TOF MS | |
Peptide mapping | RP-HPLC-UV | |
Sequence coverage | LC-MS/MS | |
N-terminal/C-terminal sequence identification | LC-MS/MS | |
Disulfide bond identification | LC-MS/MS | |
N-glycosylation site identification | LC-MS/MS | |
N-glycan analysis | HILIC-HPLC/MS | |
PTM analysis | LC-MS/MS | |
Higher order structure | CD | |
pI | cIEF; icIEF | |
Charge variants | IEC-HPLC | |
Amino acid analysis | RP-HPLC-UV/FLD | |
Purity & quantitation | Purity | SDS-PAGE; CE-SDS; iCE-SDS; SEC-HPLC |
Quantitation | UV; Bradford; Lowry; BCA; ELISA; AC-HPLC(protein A) | |
Impurity | Host cell DNA(HCD) | qPCR; SYBR green method |
Host cell Protein(HCP) | ELISA | |
Residual Protein A | ELISA | |
Safety & Stability | Bacterial Endotoxins | Tal reagent |
Microbial limit | Membrane filtration | |
Sterile examination | Membrane filtration | |
Abnormal toxicity | Animal test (mouse) | |
Mycoplasma | PCR | |
Insoluble particles | Light obscuration test | |
Visible particles | Lamp test | |
Denaturation Temperature | DSC |
Figure 1. Original mass spectrum
Figure 2. Deconvoluted mass spectrum
Figure 3. Deconvoluted mass spectrum after deglycosylation
Figure 4. N-glycan types of antibodies
(Trends in biotechnology, Volume 34, Issue 10, p835–846)
Figure 5. Total ion chromatogram of N-glycan by LC-MS method
Name | Formula | MW(labled) | Charge | Theoretical MW | Experimental MW | PPM | RT(min) | Intensity | |
---|---|---|---|---|---|---|---|---|---|
A1 | 1424.6 | +2H | 713.3 | 713.3 | 0.3 | 12.11 | 41858 | ||
M3 | 1221.5 | +2H | 611. | 611. | 0.9 | 12.11 | 1630 | ||
F(6)A1 | 1570.6 | +2H | 786.33 | 786.33 | 0.6 | 13.5 | 114406 | ||
G0 | C67H105O37N9 |
1627.7 | +2H | 814.84 | 814.84 | 0.8 | 14.02 | 2714 | |
G0F | C73H115O41N9 |
1773.7 | +2H | 887.87 | 887.87 | 0 | 15.26 | 2E+06 | |
G2-2SA | C101H159O63N11 |
2535 | +2H | 1268.5 | 1268.5 | -3.2 | 15.29 | 101 | |
M5 | 1545.6 | +2H | 773.81 | 773.81 | 0 | 16.51 | 101 | ||
G1a/G1b | C73H115O42N9 |
1789.7 | +2H | 895.86 | 895.86 | -0.8 | 16.82/17.23 | 446 | |
F(6)A1G(4)1 | 1732.7 | +2H | 867.35 | 867.35 | 0.5 | 16.85 | 56477 | ||
G0F-GN | C81H128O46N10 |
19.8 | +2H | 989.41 | 989.41 | -1 | 17.54 | 4359 | |
G1Fa/G1Fb | C79H125O46N9 |
1935.8 | +2H | 968.89 | 968.89 | -0.6 | 17.95/18.42 | 6666 | |
G2 | C79H125O47N9 |
1951.8 | +2H | 9.89 | 9.89 | -0.1 | 19.93 | 5205 | |
G1F-GN | C87H138O51N10 |
2138.9 | +2H | 1070.4 | 1070.4 | -0.6 | 20.19 | 40 | |
G1F-SA | C90H142O54N10 |
2226.9 | +2H | 4.4 | 4.4 | -0.5 | 20.27 | 29 | |
G2F | C85H135O51N9 |
2097.8 | +2H | 1049.9 | 1049.9 | -0.7 | 20.99 | 1898 | |
G2-SA | C90H142O55N10 |
2242.9 | +2H | 1122.4 | 1122.4 | -1.9 | 21. | 1037 | |
F(6)M4A1G(4)1Ga(3)1 |
2056.8 | +2H | 1029.4 | 1029.4 | 2.1 | 22.23 | 647 | ||
G2F-GN | C93H148O56N10 |
2301.9 | +2H | 1152 | 1152 | -0.5 | 22.94 | 583 | |
G2F-SA | C96H152O59N10 |
2389.9 | +2H | 1196 | 1196 | 0.1 | 23.03 | 78 | |
G2F-2SA | C107H169O67N11 |
2681 | +2H | 1341.5 | 1341.5 | -0.7 | 25.26 | 3239 |
Figure 6. 20+ N-glycan types identified in the table
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