Technology development to evaluate the effectiveness of viscosity reducing excipients.

Area of Science:

• Biopharmaceutical formulation
• Protein aggregation science
• Pharmaceutical technology

Background:

• High protein concentrations often exhibit increased viscosity, hindering subcutaneous injection and processing.
• Developing effective formulations requires a portfolio approach due to diverse protein-protein interactions.
• Traditional excipient screening is time-consuming and costly in industrial settings.

Purpose of the Study:

• To investigate protein-protein interactions influencing viscosity in concentrated formulations.
• To evaluate the interaction parameter kD as a predictive screening tool for formulation development.
• To accelerate the screening and development of pharmaceutical excipients for protein formulations.

Main Methods:

• Utilized dynamic light scattering to measure the interaction parameter kD.
• Employed in-silico calculations for excipient parameters.
• Assessed the correlation between kD and high-concentration viscosity behavior.

Main Results:

• The interaction parameter kD was identified as a key factor in protein-protein interactions.
• A qualitative correlation was established between kD and high-concentration viscosity.
• The kD parameter demonstrated suitability for high-throughput screening formats.

Conclusions:

• The interaction parameter kD can serve as an effective screening tool for protein formulations.
• This approach accelerates formulation development by reducing time and cost.
• kD facilitates the development of subcutaneous injectable protein formulations.