Electrostatic spray drying for monoclonal antibody formulation.

Area of Science:

• Pharmaceutical technology
• Biologics formulation
• Protein chemistry

Background:

• Conventional spray drying often requires high temperatures, potentially compromising protein stability.
• Monoclonal antibodies (mAbs) are crucial therapeutics requiring stable formulations.
• Developing low-temperature drying methods is essential for preserving mAb integrity.

Purpose of the Study:

• To evaluate the feasibility of electrostatic spray drying (ESD) for mAb powder production.
• To compare the protein stability of mAb powders produced by ESD versus conventional spray drying.
• To investigate the impact of lower drying temperatures on mAb formulation.

Main Methods:

• Monoclonal antibody (mAb) formulation was dried using conventional spray drying and electrostatic spray drying (ESD) with charge.
• Characterization involved solid-state Fourier transform infrared spectroscopy (ssFTIR), differential scanning calorimetry (DSC), size exclusion chromatography (SEC), and ssHDX-MS.
• Particle properties including BET surface area, particle size distribution, and morphology were analyzed.

Main Results:

• ESD at 70°C and 5 kV successfully produced mAb powders with adequate moisture content, unlike conventional spray drying at the same temperature.
• ssHDX-MS data correlated well with monomer loss observed via SEC during accelerated stability studies.
• Low-temperature ESD (70°C, 5 kV) resulted in superior protein physical stability compared to high-temperature conventional spray drying (130°C).

Conclusions:

• Electrostatic spray drying is a feasible method for producing stable mAb powder formulations.
• ESD allows for lower drying temperatures, preserving mAb physical stability.
• This technique offers an advantage over traditional spray drying for sensitive biologics.