Patent Application

App. No. 17/425,361

Abstract

Claims (76)

1 . A system comprising:

at least two vessels capable of use in the manufacture, packaging, or delivery of a biopharmaceutical product, wherein

each of said vessels comprises walls defining inner cavities, the vessels being optionally open or capable of being opened on one end or on one side;

the walls of each of said vessels having inner surfaces facing the cavities, the inner surfaces being characterized by a common surface residing thereon in substantially all areas where the inner surfaces are in contact with the biopharmaceutical product, and

the common surface comprising:

a tie coating or layer;

a barrier coating or layer; and

optionally, a pH protective coating or layer;

wherein the tie coating or layer comprising SiO x C y or SiN x C y wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3, the tie coating or layer having an outer surface facing the walls of the vessels and having an inner surface facing the cavities;

wherein the barrier coating or layer comprising SiO x , wherein x is from 1.5 to 2.9, the barrier coating or layer being from 2 to 1000 nm thick, the barrier coating or layer having an outer surface facing the inner surface of the tie coating or layer and having an inner surface facing the cavities, and

wherein the pH protective coating or layer comprising SiO x C y or SiN x C y wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3, the pH protective coating or layer having an outer surface facing the inner surface of the barrier coating or layer and having an inner surface facing the cavities.

2 . The system of claim 1 , wherein each of the vessels from that least two vessels is selected from a group consisting of one or more of the following: 384 well plates; 96 well plates; bioreactors; blood sample collection tubes; bottles; bulk storage vessels; cannulas; capture columns; cartridges; catheters; cell bank vials; cell separators; cell vials; centrifugal pumps; centrifuge tubes; chromatography columns; chromatography vials; clarifiers; closures; container closure systems; cryopreservation vessels; culture bottles; delivery containers; diafiltration equipment; dispensing units, ELISA plates; elution bags; evacuated blood sample collection tubes; fill/finish equipment; filtration equipment; freeze dryer equipment; harvest vessels; shakers; in-process analysis instruments; intermediate columns; intravenous (IV) bags; media bags; media bottles; media vessels; membrane chromatography columns; microplates; microtiter plates; microwell plates; mixing bags; monitoring devices; multiple-use bioreactors; package filling apparatus; pumps; petri dishes; pipette tips; plates; plungers; polish columns; pre-filled syringes; pre-filled syringe with luer lock fittings; primary packaging; production bioreactors; production fermenters; roller bottles; sample collection tubes; sampling vessels; seed fermenters; separators; shake flasks; single-use bioreactors; slides; spinner flasks; staked needle pre-filled syringes; storage bags; sterilizers; stock culture vials; storage containers; tanks; terminal reactors; transfer bags; ultrafiltration/diafiltration equipment; ultrafiltration equipment; upstream bioreactors; valves; vials; viral filtration equipment; viral inactivation vessels; and wave bioreactors.

3 . The system of claim 1 , wherein at least one of the vessels is selected from a group consisting of bioreactors, pumps, cell bank vials, harvest vessels, stock culture vials, fermenters, shake flasks, flasks, shakers, columns, separators, bags, beakers, tanks, cylinders, bulk storage units or containers, single use bags, roller bottles, storage tubes, sampling vessels, syringes, dispensing units, pipette tips, slides, vials and intravenous (IV) bags.

4 . (canceled)

5 . The system of claim 1 , wherein the at least two vessels comprise;

(a) a first vessel useful for holding a bulk amount of the biopharmaceutical product; and

(b) a second vessel useful for administering a composition comprising at least a portion of said biopharmaceutical product to a subject in need thereof.

6 . The system of claim 1 , wherein the at least two vessels further comprise one or more connectors connecting one or more of the vessels to one or more of another vessel or connector, wherein at least one of said connectors has a wall whose inner surface is characterized by a surface residing thereon in substantially all the areas that come into contact with the biopharmaceutical product during its production, the surface being common to the innermost surface of the one or more of the vessels and the one or more of the another vessels or connector, and wherein at least one of the connectors is independently selected from a group consisting of tubes, tubings, valves, and pipes.

7 . (canceled)

8 . (canceled)

9 . (canceled)

10 . The system of claim 5 , further comprising one or more series of vessels useful in the production of said bulk amount of the biopharmaceutical product,

wherein at least one of said vessels in the one or more series has a wall whose inner surface is characterized by a surface residing thereon in substantially all the areas that come into contact with the biopharmaceutical product during its production, the surface being not common to that of the first and second vessels, and

wherein the surface residing on said wall in substantially all the areas that come into contact with the biopharmaceutical product during its production, is common to the surface on the wall of at least one of another of said vessels in the one or more series.

11 . The system of claim 10 , wherein the common surface comprises the tie coating or layer, the barrier coating or layer, and optionally, t pH protective coating or layer;

wherein the tie coating or layer comprising SiO x C y or SiN x C y wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3, the tie coating or layer having an outer surface facing the walls of the vessels and having an inner surface facing the cavities;

wherein the barrier coating or layer comprising SiO x , wherein x is from 1.5 to 2.9, the barrier coating or layer being from 2 to 1000 nm thick, the barrier coating or layer having an outer surface facing the inner surface of the tie coating or layer and having an inner surface facing the cavities; and

wherein the pH protective coating or layer comprising SiO x C y or SiN x C y wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3, the pH protective coating or layer having an outer surface facing the inner surface of the barrier coating or layer and having an inner surface facing the cavities.

12 . A system comprising

at least two vessels capable of use in assessing one or more of the following characteristics: quality, purity, and integrity of one or more of a biopharmaceutical product, wherein

each of said vessels comprises walls defining inner cavities, the vessels being optionally open or capable of being opened on one end or on one side;

the walls of each of said vessels having inner surfaces facing the cavities, the inner surfaces being characterized by common surfaces residing thereon in substantially all areas where the inner surfaces are in contact with the biopharmaceutical product, and the common surface comprising

a tie coating or layer;

a barrier coating or layer; and

optionally, a pH protective coating or layer;

wherein the tie coating or layer comprising SiOxCy or SiNxCy wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3, the tie coating or layer having an outer surface facing the walls of the vessels and having an inner surface facing the cavities;

wherein the barrier coating or layer comprising SiOx, wherein x is from 1.5 to 2.9, the barrier coating or layer being from 2 to 1000 nm thick, the barrier coating or layer having an outer surface facing the inner surfaces of the tie coating or layer and having an inner surface facing the cavities; and

wherein the pH protective coating or layer comprising SiOxCy or SiNxCy wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3, the pH protective coating or layer having an outer surface facing the inner surfaces of the barrier coating or layer and having an inner surface facing the cavities.

13 . The system of claim 30 , wherein the common surface is either identical or not identical to one or both of a common surface of a first vessel useful for holding a bulk amount of the biopharmaceutical product and a second vessel useful for administering a composition comprising at least a portion of said biopharmaceutical product to a subject in need thereof, and to the common surface of the one or more connectors.

14 . (canceled)

15 . The system of claim 12 , wherein each vessel is selected from a group consisting of microplates, microtiter plates, microwell plates, and petri dishes.

16 . The system of claim 1 , wherein the biopharmaceutical product is selected from the group consisting of one of more of the following: an antibody, a bulk biopharmaceutical formulation, a cell culture formulation, a cell suspension, a culture fluid, a biopharmaceutical product, a biopharmaceutical substance, a biopharmaceutical formulation, an expression vector/host formulation, a harvested cell formulation, a host cell composition, a host cell contaminant, a mobile phase, a monoclonal antibody formulation, a product stream, a seed train composition, a stationary phase, a peptide or protein formulation, and a nucleic acid formulation.

17 . A method for producing a system comprising at least two vessels or connectors useful in the manufacture, packaging, or delivery of a biopharmaceutical product, each of said vessels or connectors comprising walls defining inner cavities, the vessels being optionally open or capable of being opened on one end or on one side; the walls of each of said vessels or connectors having inner surfaces facing the cavities, the method comprising:

providing a biopharmaceutical product;

providing a provisional contact surface;

determining if the biopharmaceutical product is compatible with the provisional contact surface;

modifying the provisional contact surface to improve its compatibility with the biopharmaceutical product, thereby producing a customized contact surface; and

using the customized contact surface to produce the system such that the inner surfaces of the vessels/connectors are characterized by the customized common surface residing thereon in substantially all areas where the inner surfaces are in contact with the biopharmaceutical product, the customized common surface comprising

a tie coating or layer;

a barrier coating or layer; and

optionally, a pH protective coating or layer;

wherein the tie coating or layer comprising SiO x C y or SiN x C y wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3, the tie coating or layer having an outer surface facing the walls of the vessels and having an inner surface facing the cavities;

wherein the barrier coating or layer comprising SiO x , wherein x is from 1.5 to 2.9, the barrier coating or layer being from 2 to 1000 nm thick, the barrier coating or layer having an outer surface facing the inner surface of the tie coating or layer and having an inner surface facing the cavities; and

wherein the pH protective coating or layer comprising SiO x C y or SiN x C y wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3, the pH protective coating or layer having an outer surface facing the inner surface of the barrier coating or layer and having an inner surface facing the cavities.

18 . The method of claim 17 , wherein the biopharmaceutical product is selected from the group consisting of one of more of the following: an antibody, a bulk biopharmaceutical formulation, a cell culture formulation, a cell suspension, a culture fluid, a biopharmaceutical product, a biopharmaceutical substance, a biopharmaceutical formulation, an expression vector/host formulation, a harvested cell formulation, a host cell composition, a host cell contaminant, a mobile phase, a monoclonal antibody formulation, a product stream, a seed train composition, a stationary phase, a peptide or protein formulation, and a nucleic acid formulation.

19 . The method of claim 17 where in the provisional contact surface has a water contact angle of less than 90°.

20 . The method of claim 17 , wherein provisional contact surface is characterized by one or more of:

having less than or at least 1% H bond donor groups as determined by x-ray photoelectron spectroscopy (XPS) and optionally by hydrogen forward scattering (HFS) analysis or Rutherford backscattering (RBS) analysis,

having less than 1% anion and cation groups as determined by XPS,

being essentially free of metal or metalloid atoms other than silicon as determined by XPS, and

being a plasma-enhanced chemical vapor deposition (PECVD) coating.

21 . (canceled)

22 . (canceled)

23 . (canceled)

24 . (canceled)

25 . The method of claim 17 , wherein the provisional contact surface has the following statistical ratios of silicon, oxygen, carbon, and hydrogen atoms, as determined by XPS and optionally by HFS or RBS: Si=1:O=x:C=y:H=z, in which x is from about 0.5 to about 2.9, y is from about 0 to about 3, and z is within the range from about 0 to about 9.

26 . (canceled)

27 . The method of claim 17 , wherein the provisional contact surface has the following statistical ratios of silicon, oxygen, carbon, and hydrogen atoms, determined by XPS and optionally by HFS or RBS: Si=1:O=x:C=y:H=z, in which x is from 1.5 to 2.9, y is about 0, and z is about 0.

28 . The method of claim 17 , wherein the vessel is selected from a group consisting of one or more of the following: 384 well plates; 96 well plates; bioreactors; blood sample collection tubes; bottles; bulk storage vessels; cannulas; capture columns; cartridges; catheters; cell bank vials; cell separators; cell vials; centrifugal pumps; centrifuge tubes; chromatography columns; chromatography vials; clarifiers; closures; container closure systems; cryopreservation vessels; culture bottles; delivery containers; diafiltration equipment; dispensing units, ELISA plates; elution bags; evacuated blood sample collection tubes; fill/finish equipment; filtration equipment; freeze dryer equipment; harvest vessels; shakers; in-process analysis instruments; intermediate columns; intravenous (IV) bags; media bags; media bottles; media vessels; membrane chromatography columns; microplates; microtiter plates; microwell plates; mixing bags; monitoring devices; multiple-use bioreactors; package filling apparatus; pumps; petri dishes; pipette tips; plates; plungers; polish columns; pre-filled syringes; prefilled syringe with luer lock fittings; primary packaging; production bioreactors; production fermenters; roller bottles; sample collection tubes; sampling vessels; seed fermenters; separators; shake flasks; single-use bioreactors; slides; spinner flasks; staked needle pre-filled syringes; storage bags; sterilizers; stock culture vials; storage containers; syringes (prefilled); tanks; terminal reactors; transfer bags; ultrafiltration/diafiltration equipment; ultrafiltration equipment; upstream bioreactors; valves; vials; viral filtration equipment; viral inactivation vessels; and wave bioreactors.

29 . The method of claim 17 , wherein the method of modifying the provisional contact surface of a vessel to increase its compatibility with a particular biopharmaceutical product to produce a customized contact surface comprises at least one of the following steps:

reducing the water contact angle of the provisional contact surface by about 10%-90% of the original water contact angle,

reducing the percentage of H bond donor groups of the provisional contact surface by about 10%-90%, as determined by XPS analysis and optionally HFS analysis or RBS analysis;

increasing the percentage of H bond acceptor groups of the provisional contact surface by about 10%-90%, as determined by XPS analysis and optionally HFS analysis or RBS analysis;

reducing the percentage of anion groups, cation groups, or both, of the provisional contact surface by about 10%-90%, as determined by XPS analysis; and

reducing the percentage of metal or metalloid atoms, other than silicon, of the provisional contact surface by about 10%-90%, as determined by XPS.

30 . The system of claim 12 , wherein the at least two vessels further comprise one or more connectors connecting one or more of the vessels to one or more of another vessel or connector, wherein at least one of said connectors has a wall whose inner surface is characterized by a surface residing thereon in substantially all the areas that come into contact with the biopharmaceutical product during its production, the surface being common to the innermost surface of the one or more of the vessels and the one or more of the another vessel or connector.

Assignments (9)