# US 2023/0053902 A1 · Systems and methods for manufacturing biologically-produced products

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- Number: US 2023/0053902 A1
- Document ID: US20230053902A1
- Status: Published application
- Kind: A1
- Application number: 17/690,876
- Filed: 2022-03-09
- Published: 2023-02-23
- Earliest claimed: 2017-04-01
- Assignees: Massachusetts Institute of Technology; Rensselaer Polytechnic Institute
- Applicants: Massachusetts Institute of Technology; Rensselaer Polytechnic Institute
- Inventors: J. Christopher Love; Kerry R. Love; Laura Crowell; Alan Stockdale; Richard Dean Braatz; Amos Enshen Lu; Steven Cramer; Steven Timmick; Nicholas Vecchiarello; Chaz Goodwine; Craig A. Mascarenhas
- Web page: https://patentgrep.com/patent/US20230053902A1

## CPC

- C12M 29/10: {Perfusion}
- C07K 1/20: Partition-, reverse-phase or hydrophobic interaction chromatography
- C07K 16/00: Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C12M 41/44: {of volume or liquid level}
- C12M 47/10: {Separation or concentration of fermentation products (bioreactors combined with means for distillation or extraction of liquid fuel C12M43/02)}
- C12M 47/12: {Purification (C12M47/04 takes precedence)}
- G16C 20/20: Identification of molecular entities, parts thereof or of chemical compositions
- C07K 14/535: Granulocyte CSF; Granulocyte-macrophage CSF
- C07K 14/56: IFN-alpha
- C07K 14/61: Growth hormone [GH], i.e. somatotropin
- C07K 2317/14: Specific host cells or culture conditions, e.g. components, pH or temperature
- C07K 2317/22: from camelids, e.g. camel, llama or dromedary
- C07K 2317/569: Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
- G01N 30/8658: {Optimising operation parameters}
- G16B 40/00: ICT specially adapted for biostatistics; ICT specially adapted for bioinformatics-related machine learning or data mining, e.g. knowledge discovery or pattern finding
- G16C 20/10: Analysis or design of chemical reactions, syntheses or processes
- G16C 20/70: Machine learning, data mining or chemometrics
- C12M: APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; {APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS}
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- G16C: COMPUTATIONAL CHEMISTRY; CHEMOINFORMATICS; COMPUTATIONAL MATERIALS SCIENCE
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- G16B: BIOINFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR GENETIC OR PROTEIN-RELATED DATA PROCESSING IN COMPUTATIONAL MOLECULAR BIOLOGY

## 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.

## Claims

### 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.

### Claim at position 2

2-14. (canceled)