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US 2024/0254430 A1Published application
Scalable clarification process for recombinant aav production
AssigneeREGENXBIO Inc.
InventorsClaire G. ZHANG, Shaojie WENG, Ya-Chen CHANG, Franz M. GERNER
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Abstract
Provided herein are scalable methods for the clarification of a composition comprising recombinant Adeno-Associated Virus (rAAV) particles and an impurity.
Claims36
A method for the clarification of a feed containing recombinant adeno-associated virus (rAAV) particles and an impurity comprising:
- (a) contacting the feed with a primary depth filter to generate a primary filtrate comprising the rAAV particles;
- (b) contacting the primary filtrate with a secondary depth filter to generate a secondary filtrate comprising the rAAV particles;
- and
- (c) recovering the secondary filtrate;
- wherein
- (i) the feed comprises a cell culture, a cell lysate, or a combination thereof,
- (ii) the impurity comprises cells or cellular debris,
- (iii) the method separates the rAAV particles from the impurity without the use of centrifugation or tangential flow microfiltration prior to (a), and
- (iv) the feed volume is between about 100 liters and about 3000 liters.
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Dependencies are inferred from the claim text.