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US 2026/0297693 A1Published application
Digital droplet based assay for detecting replication competent lentiviral vector
AssigneeSana Biotechnology, Inc.
InventorsAndrew TUCKER, Aesha VAKIL, Semih TAREEN
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Abstract
Among other things, the present disclosure provides methods for the detection of replication competent lentiviral vectors.
Claims39
A method of detecting replication competent lentivirus (RCL) comprising a fusogen, the method comprising:
- (a) performing a nucleic acid amplification technique on a reaction mixture,
- wherein the reaction mixture comprises a test sample that comprises test nucleic acid,
- wherein the nucleic acid amplification technique is capable of amplifying a nucleic acid encoding at least a portion of the fusogen,
- wherein a fusogen amplicon will be produced if the nucleic acid encoding the fusogen of the RCL is present in the test nucleic acid;
- and
- (b) determining whether the fusogen amplicon is produced by the nucleic acid amplification technique, wherein the presence of the fusogen amplicon indicates presence of RCL.
3 more elements
A method of manufacturing a drug product, comprising
- detecting replication competent lentivirus (RCL) in the drug product by:
- (i) performing a nucleic acid amplification technique on a reaction mixture,
- wherein the reaction mixture comprises a test sample that comprises test nucleic acid,
- wherein the nucleic acid amplification technique is capable of amplifying a nucleic acid encoding at least a portion of the fusogen,
- wherein a fusogen amplicon will be produced if the nucleic acid encoding the fusogen of the RCL is present in the test nucleic acid;
- and
- (ii) determining whether the fusogen amplicon is produced by the nucleic acid amplification technique, wherein the presence of the fusogen amplicon indicates presence of RCL.
4 more elements
Dependencies are inferred from the claim text.