Page 2 - Shimadzu Nexera lite inert

Improved Data Reliability by Preventing System Corrosion by Halogenic Salt
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Nexera lite inert Aggregates of antibody drugs show immunogenicity and cause a decrease in puri cation ef ciency and production.

Therefore, an aggregation test is one of the most critical evaluations when manufacturing biopharmaceuticals and
controlling their quality. However, a metal-free LC system is required for good repeatability over a long time due to
high-concentration, salt-containing mobile phases such as Sodium chloride. With no metal material in the ow path, Nexera
lite inert provides stable aggregate assay results with good repeatability.
mAU
The analysis of proteins such as antibody drugs requires careful operation because a high-salt mobile
800 monomer
phase sometimes corrodes the system. In addition, the adsorption of proteins to metal surfaces often mAU Analytical Conditions
6 aggregates Mobile phase 0.2 mol/L Potassium phosphate buffer
results in poor chromatographic performance. 4 containing 0.25 mol/L Potassium chloride (pH 6.2ʣ
Nexera lite inert is a robust HPLC system that eliminates the risk of corrosion by high-salt mobile phases 600 2 Flow rate 0.5 mL/min
0
and sample adsorption onto metal surfaces. It improves the data quality of protein analysis in biological -2 fragments Column TSKgel G3000SWXL
samples with superior reproducibility, without any special considerations for stable and long-term use. -4 10.0 15.0 20.0 (300 mm×7.8 mmI.D., 5 µm)
400 min Column temp. Ambient
Detection UV, 280 nm

200
Rusting

0
0.0 5.0 10.0 15.0 20.0 25.0 min Stainless-steel pump LC-40i
Monoclonal IgG antibody aggregate analysis Corrosion resistance test results of pump heads
by size exclusion chromatography

Superior Retention Time Stability by Highly Accurate Solvent Delivery

Thanks to the outstanding ow-rate stability, the Nexera lite inert provides excellent retention time repeatability.
Analytical Conditions
Mobile phase: 0.1 mol/L Potassium phosphate buffer
Repeatability of retention time:
(pH 7.0) containing 0.2 mol/LSodium
% RSD =0.08
chloride aq.
Flow Rate: 0.5 mL/min
Column: Shim-pack Bio Diol
(300 mm×4.6 mm I.D., 5 µm)
5 injection
th
Column temp.: 25ˆ
th
̐ injection Detection: UV, 280 nm
3 injection
rd
2 injection
nd
1 injection
st
0.0 5.0 10.0 15.0 min
Analysis of the aggregates in the antibody drug (n=5)

Real-Time Monitoring of Mobile Phase pH

In ion exchange or size exclusion chromatography, the pH of the mobile phase sometimes affects
the separation of compounds. The pH Monitor, pHM-40, continuously monitors and records the
pH of the mobile phase. The pH and detector chromatograms are saved within the same data le
and can be overlapped, ensuring ef cient data traceability.

Nexera lite inert
High Performance Liquid Chromatograph