Biological Therapeutics

Formulation

• Expertise in stabilisation via spray drying and lyophilisation
• Adsorption assessments with devices and clinical consumables

Stability

• Thermal stability: DSC, TGA, and hot-stage microscopy - glass transition temperatures (amorphous) or melting point (crystalline)
• Colloidal Stability: Dynamic light scattering and Nanosight particle tracking. Assessing temperature of aggregation for antibodies (Tagg)
• Hydrophobicity: Hydrophobic interaction chromatography (IHC)
• Size exclusion chromatography (SEC): Low degree aggregation into dimers, trimers, and fragments.

Structure

• Nano-differential scanning fluorimetry: Higher order structure and protein unfolding conditions.
• Intact mass analysis: Measure purity and degradation that are less apparent (oxidation, deamidation etc.)
• Bottom-up characterisation: Elucidation of degradation sites occurs (trypsin digestion).