The Thermo Scientific Dionex Ultimate 3000 Bio LC System is applied for the impurity analysis of Teriparatide formulation sample. Analysis is performed on Mabpac SEC -1

The Thermo Scientific Dionex ultimate 3000 Bio LC system is Applied for the Aggregate impurities analysis of Filgrastim. The analysis was performed on Mabpac SEC-1 using the IP monograph method. IP has revised the resolution criteira from 2.0 to 3.0. The critical resolution of Aggregate and monomer was more than 3.0 .

Analysis of protein aggregation and fragment of pertuzumab by size-exclusion chromatography, showing the universal applicability of the Thermo Scientific MAbPac SEC-1 column for aggregate and fragment analysis. Aggregate analysis is major CQA for protein based drugs and requires tight monitoring and control.

To generate a robust and reproducible bottom-up protein profiling workflow that addresses throughput requirements for plasma biomarker discovery

Analysis of protein aggregation of Aflibercept i.e fusion protein by size-exclusion chromatography, showing the universal applicability of the Thermo Scientific MAbPac SEC-1 column for aggregate analysis of fusion protein. Aggregate analysis is major CQA for protein based drugs and requires tight monitoring and control.

A UHPLC workflow for mAb aggregate analysis that operates continuously for weeks.

Analysis of protein aggregation of five important biotherapeutic monoclonal antibodies (mAbs) by size-exclusion chromatography, showing the universal applicability of the Thermo Scientific MAbPac SEC-1 column for aggregate analysis of mAbs. The biopharmaceutical industry continues to develop mAb-based biotherapeutics have several key quality attributes that require quantification. This shows the ability to determine quickly and accurately the percentage of aggregates and fragments for five therapeutics as shown with full details in the AN21601 download.

The importance of correct UHPLC instrument setup for protein aggregate analysis by size-exclusion chromatography is shown by using the Thermo Scientific Vanquish Flex Quaternary UHPLC system. For this analysis, pre-column dispersion was reduced to show the effects of dispersion in front of the column at different flow rates. After the flow rates are reduced to 300 μL/min with the MAbPac-SEC-1 column formats of 4 mm i.d., the use of low volume tubing and fittings becomes essential in order to maintain resolution of aggregates from the main peak. Refer to attached pdf file for full experiment.

The Thermo Scientific Dionex UltiMate 3000 LC Bio-LC system is applied for the Size exclusion analysis of Rituximab. The separation was performed on a Thermo Scientific MabPac SEC-1 column with a UV detection at 220 nm. With a run time of 30 minutes, the method allows easy separation of Aggregates and Dimer of Rituximab

A mix of five proteins in varying size was separated on a Thermo Scientific MabPac SEC-1 column using a Thermo Scientific Vanquish UHPLC system. The molecular weight range was 0.13 kDa – 670 kDa. Elution with high resolution of all five proteins was achieved within 15 minutes.

Size exclusion chromatography (SEC) is one of the major analyses in biotherapeutics characterization. Here we show the separation of a mAb (monomer) and its aggregates (e.g., dimer) with the Thermo Scientific Vanquish Flex UHPLC system. Produced from biological cell cultures, mAbs may contain significant amounts of dimers, trimers and other higher order aggregates. The MAbPac SEC-1 is specially designed for analysis of mAbs and their aggregates.