Methods and systems for manufacturing viral vectors
Assigneebluebird bio, Inc.
InventorsStephen Michael Dicker, Julia Ruth Deuel, Vimal H. Vaidya
Life of this patent
Estimating the term…
Abstract
Disclosed herein are methods and systems for manufacturing viral vectors (e.g., lentiviral vectors) using a static light scattering device in-line with a manufacturing process.
Claims100
A method for manufacturing viral vectors comprising using a multi-angle light scattering (MALS) device in-line with a manufacturing process to control a unit operation in the manufacturing process.
A method for detecting viral particles comprising using a multi-angle light scattering (MALS) device in-line with a manufacturing process to detect the viral particles produced during the manufacturing process.
A viral vector manufacturing process comprising clarifying viral particles harvested from host cells, separating the viral particles from impurities, filtering the viral particles, and concentrating the viral particles, wherein the manufacturing process is performed in-line with one or more MALS devices.
A method for manufacturing viral vectors comprising initiating a viral vector manufacturing process, detecting the presence of viral particles using a multi-angle light scattering (MALS) device in-line with the manufacturing process, and purifying the viral particles.
A method for removing impurities in a viral vector manufacturing process comprising separating a solution containing viral particles and impurities using chromatography and/or filtration in-line with a MALS device, wherein the MALS device controls separation of the viral particles from the impurities based on particle size.
A method for increasing the recovery of infectious viral particles in a viral vector manufacturing process comprising separating infectious viral particles from impurities in a solution using chromatography and/or filtration in-line with a MALS device, wherein the MALS device controls separation of the infectious viral particles from the impurities based on particle size.
The method of any one of claims 66-65, wherein a first MALS device is used to control separation of the infectious viral particles from the impurities and a second MALS device is used to control purification of the infectious viral particles.
A method for concentrating viral particles in a viral vector manufacturing process comprising filtering a solution comprising viral particles using tangential flow filtration in-line with a MALS device;
- wherein the MALS device determines the real-time concentration of the viral particles in solution and automates the filtering of the solution until the real-time concentration is substantially equal to a target concentration of the viral particles in the solution.
A method for controlling a unit operation in a viral manufacturing process comprising using a MALS device in-line with the manufacturing process to detect turbidity in a solution comprising viral particles and thereby control the unit operation.
A system for manufacturing viral vectors comprising a multi-angle light scattering (MALS) device in-line with the manufacturing process.
Dependencies are inferred from the claim text.