A METHOD FOR SEPARATING ADENO-ASSOCIATED VIRUS CAPSIDS, COMPOSITIONS OBTAINED BY SAID METHOD AND USES THEREOF

• Main Authors: BLOM, Hans, MALOISEL, Jean-Luc, LIND, Ola, HAGNER MCWHIRTER, Asa
• Format: Patent
• Language: English; French; German
• Published: 22.05.2024
• Subjects: BEER; BIOCHEMISTRY; CHEMISTRY; COMPOSITIONS THEREOF; CULTURE MEDIA; ENZYMOLOGY; METALLURGY; MICROBIOLOGY; MICROORGANISMS OR ENZYMES; MUTATION OR GENETIC ENGINEERING; PROPAGATING, PRESERVING OR MAINTAINING MICROORGANISMS; SPIRITS; VINEGAR; WINE

The present disclosure is directed to a method for separating adeno-associated virus capsids fully packaged with genetic material from adeno-associated virus capsids not fully packaged with genetic material, the method comprising the following steps: a) adding a liquid sample comprising adeno-associated virus capsids to a chromatography material, wherein the liquid sample comprises adeno-associated virus capsids of a purity of at least 90% and of a concentration of at least 1012 adeno-associated virus capsids/ml, of which at least 10% of the adeno-associated virus capsids are adeno-associated virus capsids fully packaged with genetic material, wherein the chromatography material comprises a strong, or partially strong, anion exchange chromatography material comprising a support and a ligand for binding to the adeno-associated virus capsids; wherein the chromatography material comprises a surface extender connecting the ligand to the support, wherein the surface extender is a polymer, wherein the polymer is selected from: (i) a polymer having a naturally occurring skeleton, such as a polysaccharide, such as starch, cellulose, dextran, or agarose; and (ii) a polymer having a synthetic skeleton, such as a polyvinyl alcohol, a polyacrylamide, a polymethacrylamide, or a polyvinyl ether; b) eluting the adeno-associated virus capsids fully packaged with genetic material from the chromatography material; wherein the adeno-associated virus capsids eluted in step (b) are eluted into eluate fractions, which eluate fractions combined comprise at least 50% of the adeno-associated virus capsids of the liquid sample added in step (a), of which at least 60% of the adeno-associated virus capsids are fully packaged with genetic material. Further disclosed are compositions, including pharmaceutical compositions, obtained by said separation method, as well as uses of such compositions, and uses of an anion chromatography material for separation of adeno-associated virus capsids.