Does controlled nucleation impact the properties and stability of lyophilized monoclonal antibody formulations?

Article ID	Journal	Published Year	Pages	File Type
8411741	European Journal of Pharmaceutics and Biopharmaceutics	2018	34 Pages	PDF

Keywords

DSC High molecular weight species Micro-Flow Imaging Physico-chemical stability HP-SEC Tg′HMW SSA PES PVDF MFI DLS mAb CMC Tff Monoclonal antibody Tangential flow filtration Karl Fischer titration Freeze-Drying glass transition temperature Nucleation temperature Residual Moisture Specific surface area BET High concentration critical micelle concentration Low concentration lactate dehydrogenase LDH Controlled nucleation XRD X-ray powder diffraction Dynamic Light Scattering polyethersulfone Polysorbate Differential scanning calorimetry Size exclusion chromatography

Related Topics

Life Sciences Biochemistry, Genetics and Molecular Biology Biotechnology

Does controlled nucleation impact the properties and stability of lyophilized monoclonal antibody formulations?

Authors

Ilona Vollrath, Wolfgang Friess, Angelika Freitag, Andrea Hawe, Gerhard Winter,