Demonstrating the Effectiveness of an Alternative to Triton X‐100 for Detergent‐Mediated Viral Inactivation in Biomanufacturing

Biotechnology and Bioengineering, Journal Year: 2025, Volume and Issue: unknown

Published: Feb. 5, 2025

ABSTRACT Detergent‐mediated viral inactivation is an important process step for ensuring safety of parenteral biotherapeutics, including plasma proteins and monoclonal antibodies (mAb). The conventional Triton X‐100 detergent has ecological toxicity concerns REACH classification that mandate replacement in the biopharmaceutical industry. Criteria a include efficacy, acceptable biodegradation profile, removal, quality suitable drug product manufacturing. A non‐ionic, C11‐15 secondary alcohol ethoxylate, Deviron 13‐S9 detergent, been demonstrated to meet necessary requirements performance. Benchmarking studies with demonstrate comparable performance panel enveloped viruses multiple matrices, human IgG, clarified cell culture harvest, fractionated plasma. efficiency or better than achieving > 5 log reduction values. Critical micelle concentration was determined across different temperatures media. be readily biodegradable according OECD 301B guidelines. absence binding typical chromatography resins used downstream purification confirmed. removal from protein‐containing matrix using protein resin. These findings support as viable alternative robust inactivation, environmental compatibility, alignment regulatory requirements.

Language: Английский

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Discovery of a Double-Stapled Short Peptide as a Long-Acting HIV-1 Inactivator with Potential for Oral Bioavailability

Journal of Medicinal Chemistry, Journal Year: 2024, Volume and Issue: 67(12), P. 9991 - 10004

Published: June 18, 2024

Different from most antiretroviral drugs that act as passive defenders to inhibit HIV-1 replication inside the host cell, virus inactivators can attack and inactivate virions without relying on their cycle. Herein, we describe discovery of a hydrocarbon double-stapled helix peptide, termed D26. D26 is based gp41 protein lentiviral lytic peptide-3 motif (LLP3) sequence, which efficiently infection cell-free virions. It was noted highly resistant proteolytic degradation exhibited remarkably extended in vivo elimination half-life. Additionally, relative its linear, nonstapled version, much higher exposure sanctuary sites for HIV-1. Amazingly, this lead compound also demonstrated detectable oral absorption. Thus, it be concluded promising candidate further development long-acting, orally applicable inactivator treatment infection.

Language: Английский

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Efficient concentration of viral nucleic acid in wastewater through surfactant releasing and a two-step magnetic bead extraction and purification

The Science of The Total Environment, Journal Year: 2024, Volume and Issue: 951, P. 175742 - 175742

Published: Aug. 24, 2024

Language: Английский

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Identification of anti-SARS-CoV-2 compounds from Qingwen Zhike prescription and exploration of their underlying mechanism by UPLC-Q-Exactive Orbitrap MS, high-throughput screening assays and transmission electron microscopy

Journal of Pharmaceutical and Biomedical Analysis, Journal Year: 2024, Volume and Issue: 255, P. 116649 - 116649

Published: Dec. 24, 2024

Language: Английский

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