Detergent-based viral inactivation: A Case Study Demonstrating Enhanced Monoclonal Antibody Purification

Virus inactivation is a critical operation in therapeutic protein manufacturing. Low pH buffers are a widely used strategy to ensure robust enveloped virus clearance. However, aggregation of certain protein products at low pH presents a challenge. One of the classical methods for viral inactivation (VI) is the detergent treatment step in the manufacturing of various drug modalities, including antibodies, plasma-derived products, and AAV. Additionally, detergent-based processes can be performed upstream of downstream steps, thereby increasing the viral safety of the overall process.

In this presentation, we will discuss the application of a novel biodegradable detergent to enhance VI while in compliance with the regulation. An extensive study with different model viruses demonstrated its capability of providing >6.5 Log of viral inactivation and high virus-killing kinetics independent of operational temperatures (4 ⁰C to RT). Other benefits of using this detergent include no environmental toxicity, and no impact on product stability or process performance. This detergent can easily be removed from the product and detected by a simple analytical assay.