# US 11,898,137 B2 · Method and system for providing buffer solutions

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- Number: US 11,898,137 B2
- Document ID: US11898137B2
- Status: Granted
- Kind: B2
- Application number: 16/876,498
- Filed: 2020-05-18
- Published: 2020-09-10
- Granted: 2024-02-13
- Earliest claimed: 2016-08-02
- Assignees: Lonza Ltd.
- Applicants: Lonza Ltd
- Inventors: Tristan Wilkins
- Web page: https://patentgrep.com/patent/US11898137B2

## CPC

- C12M 41/32: {of substances in solution}
- C12M 23/44: {Multiple separable units; Modules}
- C12M 29/00: {Means for introduction, extraction or recirculation of materials, e.g. pumps (pumps per se F04B)}
- C12M 37/00: {Means for sterilizing, maintaining sterile conditions or avoiding chemical or biological contamination (C12M23/38 takes precedence; filtration in general and filters per se B01D24/00-B01D41/00; autoclaves B01J3/04; treatment of microorganisms with electrical or wave energy C12N13/00)}
- C12M 41/36: {of biomass, e.g. colony counters or by turbidity measurements (electrooptical investigation of individual particles G01N15/14, flow cytometers G01N15/1404)}
- C12M 43/00: {Combinations of bioreactors or fermenters with other apparatus}
- B67D 7/0294: {Combined with valves}
- 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}
- B67D: DISPENSING, DELIVERING OR TRANSFERRING LIQUIDS, NOT OTHERWISE PROVIDED FOR (cleaning pipes or tubes or systems of pipes or tubes B08B9/02; emptying or filling of bottles, jars, cans, casks, barrels, or similar containers, not otherwise provided for B67C; water supply E03; pipe systems F17D; domestic hot-water supply systems F24D; measuring volume, volume flow, mass flow or liquid level, metering by volume G01F; coin-freed or like apparatus G07F)

## Abstract

A method for delivering a processing solution includes providing a concentrated processing solution in a bioprocess container, the concentrated processing solution being produced at a first site. The method also includes combining the concentrated processing solution with a biopolymer containing solution produced in a bioreactor at a second site different from the first site. In some embodiments, the processing solution is a buffer for processing products of cells cultured in a bioreactor. A system and a pharmaceutical production facility for carrying out the method is also provided.

## Claims

### Claim 1

A method for delivering a processing solution, comprising:
a. producing a concentrated processing solution at a first site;
b. storing the concentrated processing solution at the first site in a bioprocess container at a volume of at least 1000 L;
c. loading, at the first site, the bioprocess container onto a vehicle, the bioprocess container being different from the vehicle;
d. shipping, via the vehicle, the bioprocess container from the first site to a second site, the second site being different from the first site;
e. connecting the bioprocess container to at least one processing unit at the second site; and
f. flowing the concentrated processing solution from the bioprocess container to the at least one processing unit to combine the concentrated processing solution with a biopolymer containing solution produced in the at least one processing unit, wherein the concentrated processing solution is at least one of a buffer and media.

### Claim 2 (depends on 1)

The method of claim 1, wherein the first site does not include a bioreactor.

### Claim 3 (depends on 1)

The method of claim 1, wherein the second site is a GMP pharmaceutical production facility.

### Claim 4 (depends on 1)

The method of claim 1, further comprising determining a bioburden of the concentrated processing solution prior to flowing the concentrated processing solution to the at least one processing unit.

### Claim 5 (depends on 1)

The method of claim 1, further comprising diluting the concentrated processing solution from the bioprocess container by adding at least one of water and buffer from a dilution liquid to an inlet of an inline processing solution dilution system to result in a diluted processing solution.

### Claim 6 (depends on 1)

The method of claim 1, wherein the at least one processing unit comprises a plurality of bioreactors.

### Claim 7 (depends on 1)

The method of claim 1, wherein the concentrated processing solution is one of Tris, Tris-Base, Tricine, HEPES, MOPS, PIPES, TAPS, bicine, BES, TES, cacodylate, MES, acetate, MKP, ADA, ACES, glycinamide, acetamidoglycine, acetic acid, citric acid, glycine, glycine glycinate, sodium phosphate, ethanol, hydrochloric acid, sodium hydroxide, guanidinium chloride, guanidine hydrochloride, sodium chloride, and a combination of any of these.

### Claim 8 (depends on 1)

The method of claim 1, further comprising determining, via a first controller, a need for the concentrated processing solution at the second site and communicating the need for the concentrated processing solution to a second controller at the first site.

### Claim 9 (depends on 1)

The method of claim 1, further comprising tracking the bioprocess container during the shipping, connecting and flowing, via an RFID tag on the bioprocess container.