Microwave-Assisted Freeze-Drying of Monoclonal Antibodies: Product Quality Aspects and Storage Stability.

In order to overcome the downside of long conventional freeze-drying (CFD) process times for monoclonal antibody formulations, microwave-assisted freeze-drying (MFD) was introduced. Recently, the general applicability and potential shortening of drying times were shown. However, little is known about the storage stability of MFD products compared to CFD references.

Overcoming challenges in co-formulation of proteins with contradicting stability profiles - EPO plus G-CSF.

The co-formulation of drugs is widely used for small molecules, e.g. fixed-dose-combinations of synergistic medicines in the treatment of infections, diabetes or neurodegenerative diseases.

A Comparison of Controlled Ice Nucleation Techniques for Freeze-Drying of a Therapeutic Antibody.

The aim of this study was to investigate if mechanistically different controlled ice nucleation techniques in freeze-drying are comparable to each other with respect to drying process performance and product quality attributes. Therefore, we studied 3 different model formulations including amorphous (sucrose, trehalose) and semi-crystalline (mannitol:sucrose 4:1) solids containing a monoclonal antibody IgG (5 g/L) processed either by application of ice fog or depressurization technique setting an ice nucleation temperature of -5°C. Subsequently, the same freeze-drying protocol on identical machinery was applied.

Significant Drying Time Reduction Using Microwave-Assisted Freeze-Drying for a Monoclonal Antibody.

Microwave-assisted freeze-drying (MFD) is a rapid drying process well known in food technology. However, little is known about its application to biologicals. In this study, we investigated the applicability and feasibility of this technology to different monoclonal antibody formulations and the influence on the resulting product properties.