Systems and methods for manufacturing biologically-produced products

Patent metadata

Field	Value
Publication number	US-2023053902-A1
Application number	US-202217690876-A
Country	US
Kind code	A1
Filing date	Mar 9, 2022
Priority date	Apr 1, 2017
Publication date	Feb 23, 2023
Grant date	—

Abstract

Aspects of the present disclosure relate to systems and methods for manufacturing biologically-produced pharmaceutical products. Some of the systems described herein comprise an upstream component comprising a bioreactor and at least one filter (e.g., a filter probe) integrated with a downstream component comprising a purification module comprising at least a first partitioning unit and a second partitioning unit. In some embodiments; these integrated biomanufacturing systems may be operated under continuous or conditions and may be capable of efficiently producing pure, high-quality pharmaceutical products.

First claim

1 . A biomanufacturing system, comprising:
a perfusion bioreactor, wherein the perfusion bioreactor comprises:
a reaction chamber configured to receive at least one feed stream comprising at least one cell culture medium;
a suspension comprising the at least one cell culture medium and at least a first type of biological cells configured to express at least one biologically-produced product;
at least one filter probe at least partially submerged in the suspension, wherein the at least one filter probe is configured to produce at least one filtrate stream lean in the first type of biological cells relative to the suspension, wherein the at least one filtrate stream comprises the at least one biologically-produced product;
an adjustment module fluidically connected to the perfusion bioreactor, wherein the adjustment module is configured to adjust one or more properties of the at least one filtrate stream to produce an adjusted filtrate stream; and a purification module fluidically connected to the adjustment module, wherein the purification module is configured to remove at least a first type of impurity and a second type of impurity from the adjusted filtrate stream to produce a purified filtrate stream, wherein the purification module comprises:
a first partitioning unit configured to remove at least the first type of impurity from the adjusted filtrate stream to produce a first partitioned filtrate stream lean in the first type of impurity relative to the adjusted filtrate stream, wherein the first partitioned filtrate stream comprises the at least one biologically-produced product; and
a second partitioning unit configured to remove at least a second type of impurity from the first partitioned filtrate stream to produce a second partitioned filtrate stream lean in the second type of impurity relative to the first partitioned filtrate stream, wherein the second partitioned filtrate stream comprises the at least one biologically-produced product, wherein the system is configured to be continuously operated.

2 - 14 . (canceled)

Assignees

• Massachusetts Inst Technology
• Rensselaer Polytech Inst

Inventors

• Love J Christopher
• Love Kerry R
• Crowell Laura
• Stockdale Alan
• Braatz Richard Dean
• Enshen Lu Amos
• Cramer Steven
• Timmick Steven
• Vecchiarello Nicholas
• Goodwine Chaz
• Mascarenhas Craig A

Classifications

• C12M41/44

  of volume or liquid level · CPC title

• G16C20/20

  Identification of molecular entities, parts thereof or of chemical compositions · CPC title

• C12M29/10 Primary

  Perfusion · CPC title

• C07K16/00

  Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies · CPC title

• C07K2317/14

  Specific host cells or culture conditions, e.g. components, pH or temperature · CPC title