DETERGENT FOR VIRAL INACTIVATION
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United States of America
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Issued Date -
Feb 6, 2025
app pub date -
Dec 16, 2022
filing date -
Dec 16, 2022
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Abstract
The present disclosure provides compositions and methods of inactivating a lipid enveloped virus in a product feedstream in a manufacturing process of a therapeutic protein using environmentally compatible detergents. The present disclosure provides a detergent mixture comprising two environmentally sustainable detergents: n-Octyl-β-D-Glucopyranoside (OG) and n-Dodecyl-β-D-Maltopyranoside (DDM). The performance of this OG:DDM detergent combination is superior to that of Lauryldimethylamine Oxide (LDAO), ECOSURF™ EH9, or Triton X-100 in the purification of therapeutic proteins such as abatacept and belatacept. OG:DDM combinations are highly effective for viral inactivation, while having essentially no impact on protein stability, protein charge distribution (e.g., sialic acid levels), impurity clearance, protein deamination, or protein oxidation. Accordingly, combinations of OG and DDM can be used as substitutes of Triton X-100 for viral inactivation steps in the production of biologics.
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