Due to their specificity and efficacy, protein-based or antibody-based biologics have become a rapidly growing area in the biotherapeutics market for the diagnosis and treatment of autoimmune diseases, cancer, cardiovascular diseases, infectious diseases, and inflammation. During the research and development of therapeutic proteins or antibodies, the amount of impurities, structural variants, and post-translational modification variants must be monitored, characterized, and quantified, which are critical quality attributes (CQAs) to demonstrate the stability and efficacy of the final products. Quality control and stability evaluation of biologics are challenging due to their complex microscopic heterogeneity.
High performance liquid chromatography (HPLC) is an important analytical technique for characterizing and quantifying impurities and variants in proteins, antibodies, and related substances. Due to the complex nature of these molecules, Amerigo Scientific offers BioCore columns designed for liquid chromatography analysis of antibodies, proteins and related substances. There are a variety of chromatographic columns for characterization based on different separation modes, including size exclusion chromatography (SEC) for aggregates and fragments, ion-exchange chromatography (IEC) for charged variants, hydrophobic interaction chromatography (HIC) for drug antibody ratio (DAR) analysis in antibody-drug conjugates (ADCs), reversed phase chromatography (RPC) for exact mass determination of antibodies and their subunits, hydrophilic interaction chromatography (HILIC) for glycans, and protein A affinity chromatography for titer analysis of proteins and antibodies. These BioCore columns can be used in biotechnology research, and development of biopharmaceuticals or diagnostic reagents.
BioCore SEC Columns
Size exclusion chromatography (SEC) is an important analytical technique for determining aggregate and fragment content in antibody biologics. BioCore SEC columns are designed for separating antibodies, proteins, peptides, oligonucleotides and related substances in biotechnology, biopharmaceutical development, and academic research.
| Product |
Functional Group |
Particle Size |
Pore Size |
Temperature Limit |
pH Range |
Application |
| BioCore SEC-120
|
Diol |
1.8, 3 & 5 µm |
120 Å |
40 °C |
2-8 |
Small-molecule drugs, peptides, glycans, small oligos |
| BioCore SEC-150
|
Diol |
1.8, 3 & 5 µm |
150 Å |
40 °C |
2-8 |
Peptides, heparin, glycans, small oligos, and small proteins |
| BioCore SEC-300
|
Diol |
1.8, 3 & 5 µm |
300 Å |
40 °C |
2-8 |
Aggregates and fragments in antibodies, proteins, and DNA/RNA |
| BioCore SEC-500
|
Diol |
1.8, 3 & 5 µm |
500 Å |
40 °C |
2-8 |
High order aggregates in antibodies, larger proteins, and DNA/RNA |
BioCore IEX Columns
Charge variant is generally considered a critical quality attribute in biopharma development and therefore needs to be closely monitored to ensure the safety and efficacy of biotherapeutics. Depending on the specific conditions of production or the intrinsic properties of proteins or antibodies, charge variants can contain acidic or basic variants. Ion-exchange chromatography (IEX) is a commonly used method that separates molecules based on differences in ionic groups on the surface of biomolecules. Amerigo Scientific offers a range of BioCore IEX columns for the separation of charged variants in antibodies, proteins and related substances.
| Product |
Functional Group |
Particle Size |
Pore Size |
Temperature Limit |
pH Range |
Application |
| BioCore WCX
|
Carboxylate |
5 & 10 μm |
Nonporous |
60 °C |
2-12 |
Charge variants in antibodies and proteins |
| BioCore SCX
|
Sulfonate |
| BioCore WAX
|
Tertiary Amine |
| BioCore SAX
|
Quaternary Ammomiun |
Other Columns
Protein glycosylation is one of inherent sources of the heterogeneity of biotherapeutics, which affects the safety, efficacy, and half-life of therapeutic glycoproteins. Amerigo Scientific provides hydrophilic interaction liquid chromatography (HILIC) columns for the N-glycan analysis of antibodies and proteins. In addition, we also provide columns based on protein A ligand-based affinity chromatography columns for the concentration determination of monoclonal antibodies and Fc fusion proteins.
Both hydrophobic interaction chromatography (HIC) and reversed phase chromatography (RPC) utilize changes in hydrophobicity for the separation of target molecules. Unlike RPC technique, HIC uniquely allows analysis under mild, nondenaturing conditions, preserving the native structure and activity of the molecules. Amerigo scientific offers BioCore HIC for the DAR analysis of ADCs or oxidation variants in antibodies.
| Product |
Functional Group |
Particle Size |
Pore Size |
Temperature Limit |
pH Range |
Application |
| BioCore Glycan
|
Polyamide |
3 µm |
180 Å |
80 °C |
2-9 |
N-glycan analysis in antibodies and proteins |
| BioCore Protein A LC
|
pH stable rProtein A |
15 µm |
1000 Å |
2-40 °C |
2-12 |
Fast titer analysis of mAb and Fc fusion proteins |
| BioCore HIC LC
|
Butyl |
5 µm |
1000 Å |
60 °C |
2-8 |
DAR analysis in ADCs, oxidation variants in mAbs |
| BioCore RP LC
|
Butyl |
5 µm |
Nonporous |
100 °C |
2-12 |
Intact protein and protein fragment analysis |
Features of BioCore Columns
- BioCore media are monodisperse spherical particles. The use of a uniquely designed surface modification and grafting technology ensures the biocompatibility of and selectivity of media required for the separation of antibodies, proteins, and related substances.
- Each batch of BioCore media is produced according to strict quality management standards and tested with relevant biomolecules to ensure performance and batch-to-batch consistency.
- BioCore columns employ innovative particle technology, advanced column chemistry, and robust packing method to ensure superior performance, quality, and robustness.
- Each BioCore column is manufactured by a well-developed packaging method and tested individually to ensure quality and consistency. Each column is shipped with a media assurance certificate and a column quality assurance report.
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