Improved virus purification processes for vaccines and gene therapy

Area of Science:

• Biotechnology
• Pharmaceutical Manufacturing
• Process Engineering

Background:

• Upstream production of virus particles for vaccines and gene therapy is advancing, leading to higher titers.
• This progress creates a bottleneck in downstream processing, impacting overall production efficiency and cost.
• Increasing demand for cost-effective biopharmaceutical manufacturing necessitates innovative downstream strategies.

Purpose of the Study:

• To review the current state-of-the-art in viral downstream purification processes.
• To analyze classical unit operations and their recent advancements in viral purification.
• To explore novel strategies for process intensification and discuss their impact on efficiency.

Main Methods:

• Comprehensive literature review of viral downstream purification techniques.
• Analysis of established unit operations (e.g., chromatography, filtration).
• Investigation of emerging technologies, including continuous and semi-continuous systems (e.g., multicolumn chromatography).

Main Results:

• Classical downstream operations are being optimized for viral purification.
• Continuous and semi-continuous processing, particularly multicolumn technology, shows significant potential for process intensification.
• Integration of process understanding principles, such as Quality by Design (QbD), is crucial for robust viral purification.

Conclusions:

• Downstream processing remains a critical challenge in viral vector production.
• Novel approaches like continuous manufacturing offer pathways to overcome current limitations.
• Future developments will likely focus on integrated, intensified, and QbD-compliant purification strategies for efficient viral production.