Analytical instruments including the PA 800 and CESI 8000 systems from Beckman Coulter, placed on a lab bench with a computer setup.

At Applied BioAnalytics we know that each therapeutic is unique, as are the teams developing them. Your team and your therapeutics in particular. We offer personalized and comprehensive services based on industrial standard procedures and detailed knowledge of regulatory requirements. Our staff’s expertise includes but is not limited to:

Your source for new & improved methods, including qualification

▪ Size heterogeneity and purity assessment via CE-SDS and CE(SDS)-MS
– Including the use of our flat baseline CE-SDS gel
▪ Charge heterogeneity analysis via cIEF
▪ Charge variant analysis via CZE

▪ N-Linked oligosaccharide profiling via CE-LIF
▪ Quantitative monosaccharide analysis via CE-LIF
▪ Quantitative sialic acid speciation via CE-LIF

▪ Exoglycosidase mediated glycan sequencing /mapping via CE-LIF
▪Viral vector purity, empty/full, and quantification via CGE

Example 1 –
High resolution glycan profiling

N-glycan composition profiling is essential for quality testing of biotherapeutics because the glycan structure is designated as a critical quality attribute (CQA) that must be monitored during manufacturing. The glycan profile of a finished product is used to assess the consistency of a manufacturing process from batch to batch. Our capillary electrophoresis separation-based glycan profiling technology enables extraordinary resolution, which cannot be addressed by LC methods alone.

Peer-reviewed publication showcasing sample preparation scale-up for deep N-glycomic analysis using capillary electrophoresis and CE-ESI-MS, featuring technical diagrams, electropherograms, and data visualizations relevant to biomolecular research.

Mol Cell Proteomics. 2019 Dec;18(12):2524-2531

Example 2 –
Automated carbohydrate sequencing

In addition to high resolution glycosylation profiling, carbohydrate sequencing is an important part of bioprocess analysis, especially when clients have unknown peaks in their sample. In glycan sequencing, carbohydrates are sequentially digested by various linkage-specific exoglycosidase enzymes allowing complete, high confidence structural elucidation for biological-relevance exploration or structural identity confirmation. Our in-house developed and validated semi- and fully automated sequencing methods ensure robust and fast service not available from other companies.

Scientific Reports article on automated N-glycosylation sequencing of biopharmaceuticals using capillary electrophoresis, featuring data tables, electropherograms, and annotated results supporting advanced glycan analysis workflows.

Sci Rep. 2017 Sep 15;7(1):11663

Example 3 –
Purity and heterogeneity measurements & demonstrative measurement results

Precise determination of low-level impurities of biologics is a challenging bioanalytical task through the entire biologics and biosimilar development pipeline. Biopharma analytical laboratories require quantitative and validated data, which is exactly what Applied Bio-Analytics offers via utilization of the CE-SDS-MW method, which allows for the resolution of reduced and non-reduced mAb’s by size and to subsequently quantify the heterogeneity and impurities that may be present in mAb preparations. High quality CE-SDS data provides the critical confidence required for right decision-making – not necessarily available using other technologies. High reproducibility of our CE-SDS-MW measurement was confirmed by a 6-day trial with six runs per day using our internal standard monoclonal antibody sample. Our optimized methods offer excellent relative standard deviation (RSD) values for HC peak %Corrected area (under 0.2%), which is below the RSD value reported by the vendor of the kit used (see Figure 1 and Table).

A preview of a scientific research article from Analytica Chimica Acta, showing a cover page with a title, abstract, and molecular illustration, followed by pages featuring a detailed flowchart and electropherogram data plots. The document demonstrates advanced analytical techniques and scientific data presentation.

Sarkozy D, Guttman A. Analysis of Peptides and Proteins by Native and SDS Capillary Gel Electrophoresis Coupled to Electrospray Ionization Mass Spectrometry via a Closed-Circuit Coaxial Sheath Flow Reactor Interface. Anal Chem. 2023 May 9;95(18):7082-7086. doi: 10.1021/acs.analchem.2c04332.

Electropherogram showing SDS-MW separation of Daratumumab monoclonal antibody (mAb) across six analytical runs. Distinct peaks indicate molecular weight components, including 10 kDa marker, light chain (LC), non-glycosylated heavy chain (ngHC), and heavy chain (HC). The plot demonstrates consistent migration profiles and separation efficiency over time.

Figure 1. SDS-MW separation of Daratumumab mAb sample

able displaying the statistical analysis of SDS-MW separation of Daratumumab monoclonal antibody (mAb) across six runs. It includes migration time and percentage corrected area for five identified peaks (LC, ngHC, HC, Peak #4, and Peak #5). For each peak, average values, standard deviations, and %RSD (relative standard deviation) are provided, demonstrating the method’s precision and reproducibility.
Table 1. Statistical evaluation of SDS-MW separation of
Daratumumab mAb sample

Example 4 –
Charge variant and
charge heterogeneity analysis &
demonstrative measurement results

Working with biologics, especially with mAbs, requires information on different charge variants to determine identity and stability. Post-production analysis by cIEF can give information about purity, stability, and post-translational modifications of therapeutic proteins. By capillary isoelectric focusing (cIEF) we offer our clients ultra-high resolution charge heterogeneity data. cIEF is inherently consistent allowing global assessment, which is critical to both R&D and meeting regulatory requirements.

Marton Szigeti et al, Highly robust and reproducible charge heterogeneity analysis of monoclonal antibodies by cIEF, AT Europe Virtual Symposium, November 3-6, 2020Sci Rep. 2017 Sep 15;7(1):11663

Electropherogram showing capillary isoelectric focusing (cIEF) analysis of Daratumumab monoclonal antibody (mAb) sample using capillary electrophoresis (CE). Six overlaid runs display consistent peaks centered between pI markers 10.0 and 7.0, indicating a stable isoelectric point distribution across multiple measurements.

Figure 2. cIEF analysis of Daratumumab mAb sample with CE

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