Viral Clearance breakthrough: Enhancing efficacy and protein stability with a regulatory compliant, novel detergent

Implementing of effective viral clearance processes during biologics manufacturing are the final shield to ensure product and patient safety. One of the classical methods for viral inactivation (VI) is the detergent treatment step in manufacturing of various drug modalities, including antibodies, plasma-derived products and AAV. In this presentation, we will discuss on the application of a novel biodegradable detergent to enhance VI while in compliance with 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, no impact on product stability or process performance. This detergent can easily be removed from the product and be detected by a simple analytical assay.

This presentation was given at BPI Europe, April 11, 2024.

Presented by:

Willy Hesselink Senior Technical Application Project Manager Willy Hesselink is Senior Technical Application Project Manager at Avantor´s biopharma production unit. Prior to this role, he was R&D Manager at Avantor Performance Materials. Willy brings over 20 years of industrial expertise in the R&D of raw materials + excipients for biopharma processes. In his current role, he has led many process optimization and TCO projects in collaboration together with clients. Willy holds a B.Sc. in analytical chemistry from the Saxion Univ. of Applied Sciences in Enschede, Netherlands.