Quantification methods for viruses and virus-like particles applied in biopharmaceutical production processes

Area of Science:

• Biotechnology
• Pharmaceutical Manufacturing
• Analytical Chemistry

Background:

• Cell-based production of virus particles is crucial for vaccines, gene therapies, and oncolytic treatments.
• Regulatory standards necessitate robust process analytics for efficient development and production control.
• Accurate quantification of viral products and contaminants is essential for pharmaceutical release.

Purpose of the Study:

• To review and categorize analytical methods for quantifying viruses and virus-like particles.
• To compare techniques based on their analytical focus, advantages, drawbacks, assay time, and throughput.
• To identify trends and future directions in viral particle quantification.

Main Methods:

• Literature review of analytical techniques for virus quantification.
• Categorization of methods based on analytical objectives (infectivity vs. particle counting).
• Comparative analysis of methods regarding speed, throughput, and applicability.

Main Results:

• Various analytical methods are available for virus quantification, focusing on infectivity or particle enumeration.
• Techniques differ significantly in assay time, sample throughput, and suitability for different applications.
• A clear trend towards rapid, high-throughput, and automated methods is observed.

Conclusions:

• Advancements in miniaturization and automation are driving the development of faster analytical methods.
• Enhanced process-relevant databases will support improved process control in viral production.
• The future of viral particle analytics lies in integrated, high-throughput, and automated solutions for efficient biopharmaceutical manufacturing.