Methods and systems for manufacturing viral vectors

A viral vector and lentiviral vector technology, applied in the field of manufacturing viral vectors and systems, can solve the problems of inability to make real-time decisions, lengthy determination of viral vectors, non-existence, etc.

Inactive Publication Date: 2022-03-18
BLUEBIRD BIO INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Quantification and characterization of viral vectors often requires lengthy assays, which prevents real-time decision-making during the manufacturing process
Furthermore, currently no tandem solution exists to control the separation of intact viral vector particles from their process-specified impurities such as exosomes

Method used

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  • Methods and systems for manufacturing viral vectors
  • Methods and systems for manufacturing viral vectors
  • Methods and systems for manufacturing viral vectors

Examples

Experimental program
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Embodiment

[0106] MALS detectors are connected in series with viral vector manufacturing process unit operations for detection, automation or decision making based on data obtained during the manufacturing process.

[0107] Such as figure 2 As shown, a MALS detector was attached to the effluent of the chromatography skid in order to assess the presence and size of viral vectors passing through it. The information collected by the MALS detector can be used online to automate downstream valves that can separate populations of particles of different mean radii, as detected by MALS. The radius is measured in real time by MALS as the analyte passes through the inline flow cell. Multi-angle light scattering can directly measure the root mean square radius of particles. The root mean square radius is model independent; that is, it does not assume a specified molecular conformation. Root mean square radius values ​​can be used to calculate the geometric radius of spherical particles. There ...

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Abstract

Disclosed herein are methods and systems for manufacturing viral vectors (e.g., lentiviral vectors) using a static light scattering device in series with the manufacturing process.

Description

[0001] related application [0002] This application claims the benefit of U.S. Provisional Application No. 62 / 795,513, filed January 22, 2019, the contents of which are incorporated herein by reference in their entirety. Background technique [0003] Gene therapy using viral vectors is an area that has attracted significant attention. However, the ability to efficiently manufacture large quantities of viral vectors remains an issue. Currently there are no in-line process analytical technology (PAT) solutions for detection or quantification of viral vectors during the manufacturing process. There is also no in-line process for controlling the separation of non-infectious particles from infectious particles during the manufacturing process. Quantification and characterization of viral vectors often requires lengthy assays, which prevent real-time decision-making during the manufacturing process. Furthermore, currently no tandem solution exists to control the separation of in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A01H5/00A01H6/82A61K39/145A61K39/39C07K14/005C12N7/04
CPCC12N15/86C12N2740/16051C12N7/00C12N2740/16043C12N2710/10051C12N2710/10043C12N2710/24151C12N2710/24143C12N2740/15043C12N2740/15051C12N2710/16051C12N2710/16043G01N15/14G01N30/74
Inventor 斯蒂芬·迈克尔·迪克茱莉亚·鲁斯·德厄尔维姆·H·维迪亚
Owner BLUEBIRD BIO INC
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