Characterization of impurities in adeno-associated virus (AAV) samples and formulation compositions for stabilizing AAV

Methods for characterizing DNA impurities in an adeno-associated virus (AAV) sample or biopharmacy are provided, the methods comprising the use of size exclusion chromatography and spectrophotometry. Also provided are methods and compositions for minimizing leakage of packaged DNA from AAV vectors,...

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Bibliographic Details
Main Authors LIU DAVID, TZUR FAYSAL, JIANG BO
Format Patent
LanguageChinese
English
Published 01.08.2023
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Summary:Methods for characterizing DNA impurities in an adeno-associated virus (AAV) sample or biopharmacy are provided, the methods comprising the use of size exclusion chromatography and spectrophotometry. Also provided are methods and compositions for minimizing leakage of packaged DNA from AAV vectors, the methods comprising the use of excipients such as sugars, amino acids, surfactants, or polyols. 提供了用于表征腺相关病毒(AAV)样品或生物制药中的DNA杂质的方法,所述方法包含使用尺寸排阻色谱法和分光光度法。还提供了用于使包装的DNA从AAV载体中泄漏最小化的方法和组合物,所述方法包含使用如糖、氨基酸、表面活性剂或多元醇等赋形剂。
Bibliography:Application Number: CN202180073988