BIOSOL 100

Spectrophotometric thermodynamic intrinsic solubilization kinetics analysis of biological charge variants

Qualitative and quantitative ingredient screening during analytical and toxicological development aimed at determining speed and size of the possible formation of primary and/or secondary ingredient aggregates and their reversibility (dissolution kinetics) or irreversibility (precipitate kinetics)
Anti-counterfeiting ingredient profiling including quantitative ingredient interaction potential profiling
Stability testing and QC – lot-to-lot consistency testing
Pre-formulation development identifying potential structural ingredient specific impurities
Optimization and planning of manufacturing processes

References:

Füssl F, Cook K, Scheffler K, Farrell A, Mittermayr S, Bones J
Charge Variant Analysis of Monoclonal Antibodies Using Direct Coupled pH Gradient Cation Exchange
Chromatography to High-Resolution Native Mass Spectrometry
Anal Chem 2018; (90) 7: 4669 – 4676
doi: 110.1021/acs.analchem.7b05241
FDA Center For Biologics Evaluation and Research (CBER)
Considerations in Demonstrating Interchangeability With s Reference Product
Guidance for Industry January 12, 2017