How spray drying processing and solution composition can affect the mAbs stability in reconstituted solutions for...

Area of Science:

• Pharmaceutical Science
• Biotechnology
• Chemical Engineering

Background:

• Spray drying is a widely used technique for biopharmaceutical formulation.
• However, the process can induce stresses that compromise protein stability.
• Optimizing formulation composition and process conditions is crucial for stable spray-dried biopharmaceuticals.

Purpose of the Study:

• To investigate the impact of spray drying processing and solution composition on monoclonal antibody (mAb) stability.
• To determine the influence of excipients and protein concentration on mAb stability during spray drying.
• To identify optimal formulation strategies for stable, spray-dried mAb powders for subcutaneous injection.

Main Methods:

• Decoupling of process stresses (shear, thermal/dehydration) to assess individual stressor effects.
• Systematic variation of mAb-A concentration and excipient types (sugars, amino acids, surfactants) and concentrations.
• Analysis of reconstituted spray-dried mAb-A powders for aggregation and turbidity.

Main Results:

• Excipients and protein concentration were found to be more critical for stabilizing mAb-A than spray drying operating conditions.
• Increased concentrations of excipients, particularly surfactants, correlated with reduced aggregation and turbidity.
• A suitable formulation composition was identified to ensure robust stability of spray-dried mAb-A.

Conclusions:

• Formulation composition, especially excipient type and concentration, plays a pivotal role in stabilizing mAbs during spray drying.
• Surfactants are particularly effective in mitigating aggregation and turbidity in reconstituted spray-dried mAb powders.
• These findings advance the development of stable and effective pharmaceutical formulations for subcutaneous injection.