High-Throughput Process Development for the Chromatographic Purification of Viral Antigens

Area of Science:

• Biotechnology
• Process Development
• Vaccine Manufacturing

Background:

• Chromatography is crucial for separating products and impurities in biotechnology.
• Developing purification processes for multivalent viral antigens is complex due to diverse protein subunits.
• Traditional methods are labor-intensive, costly, and time-consuming, necessitating efficient strategies.

Purpose of the Study:

• To address the challenges in developing purification strategies for viral antigens, particularly for multivalent vaccines.
• To introduce and demonstrate an automated method for rapid evaluation of chromatography conditions.
• To accelerate the process development of viral antigen purification.

Main Methods:

• Utilized a Tecan Freedom EVO automated liquid handler for high-throughput screening.
• Employed scale-down purification with <1.0 mL column volumes.
• Evaluated various resin chemistries and buffer conditions to identify optimal purification strategies.

Main Results:

• Demonstrated a methodology for automated purification script development.
• Successfully applied the automated script for efficient purification development of different rotavirus antigen serotypes.
• Enabled rapid evaluation of viral antigen separation with limited prior knowledge of chromatography behavior.

Conclusions:

• Automation and scale-down approaches significantly enhance throughput in purification process development.
• The described automated method facilitates rapid identification of suitable purification strategies for viral antigens.
• This approach accelerates the development and validation of purification processes for complex vaccine products.