ICH Topic Q6b requests that “Chromatographic patterns and data on identity, homogeneity, and purity can be obtained by size-exclusion chromatography, reverse-phase liquid chromatography, ion-exchange liquid chromatography, affinity chromatography or other suitable procedures”
BioPharmaSpec performs a comprehensive range of chromatography methods to provide you with chromatographic patterns for your biopharmaceutical, including:
- Reversed Phase-HPLC (RP-HPLC)
- Cation Exchange Chromatography (CEX)
- Anion Exchange Chromatography (AEX)
- Hydrophobic Interaction Chromatography (HIC)
- Size Exclusion Chromatography (SEC)
- SEC-MALS analysis, for aggregation analysis
The above chromatographic analyses provide product distributions based on size, hydrophilicity/hydrophobicity and charge distribution.
BioPharmaSpec utilizes both electrophoretic and liquid chromatographic instrumentation and methodologies to provide you with information relating to the identity, homogeneity, and purity of your product. The techniques can also be used to purify impurities for identification and structural characterization.