Classifications

• • C—CHEMISTRY; METALLURGY
  • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
  • 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
  • C12M23/00—Constructional details, e.g. recesses, hinges
  • C12M23/02—Form or structure of the vessel
  • C12M23/14—Bags
• • C—CHEMISTRY; METALLURGY
  • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
  • 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
  • C12M29/00—Means for introduction, extraction or recirculation of materials, e.g. pumps
• • C—CHEMISTRY; METALLURGY
  • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
  • 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
  • C12M29/00—Means for introduction, extraction or recirculation of materials, e.g. pumps
  • C12M29/04—Filters; Permeable or porous membranes or plates, e.g. dialysis

Definitions

• the invention relates to the development of a biopharmaceutical product and more particularly relates to a process for producing a biopharmaceutical product in and with a pocket assembly chosen for this purpose, such a pocket assembly specially designed for of this method, such a pocket assembly before filling the contents and such a pocket assembly filled with elaborated biopharmaceutical product, and finally an assembly comprising, firstly, a pocket assembly and, secondly, means for activating the own medium for supporting and exchanging the pocket assembly.
• Biopharmaceutical product means a product derived from biotechnology - culture media, cell cultures, buffer solutions, artificial nutrition liquids, blood products and derivatives of blood products - or a pharmaceutical product or, more generally, a product intended to be used in the medical field. In the context of the invention, this biopharmaceutical product has the characteristic of being in substantially liquid or pasty form.
• Such a device comprises firstly a pocket assembly including in the first place the actual pouch in question defining an interior space capable of containing the biopharmaceutical product, limited by a wall, as a whole, in a flexible plastic film, sealed, non-degradable, adapted to be in direct contact with its inner face with the biopharmaceutical product and contain it and, secondly, associated with the pocket, at least one port, and, where appropriate, at least one functional device such a device may then comprise, if necessary, a rigid outer receiving container in its own interior space of the pocket assembly.
• “Development process” means one or more phases of a physico-chemical-biological process during which the biopharmaceutical product is wholly or partly manufactured until it reaches the finished state allowing its direct use or a state semi-finished for later use.
• Such a phase consists, for example, in the addition of one or more components by virtue of the at least one port of the bag assembly, or in a mixture, aeration, filtration, reaction, heating or This list is not exhaustive, thanks to the at least one adapted functional device of which the pocket assembly is provided.
• biopharmaceutical product is intended to mean both the finished biopharmaceutical product and a biopharmaceutical product. intermediate product of the process of developing it.
• pocket assembly having a pocket whose two large walls are directly joined to one another. Once expanded, such a pocket has a limited volume and remains relatively thin, which justifies it is often called “pillow pocket", or pocket “2D” (D meaning dimensions).
• a gusseted 3D pocket is also known which has two end walls and one side wall can be folded flat or unfolded unfolded, welded together, the volume can be then at least 50 liters, up to 3000 liters or more.
• Such a 3D pocket is described in the document WO00 / 04131 or sold by the company Sartorius Stedim Biotech under the trade mark FLEXEL ® 3D.
• the pocket wall fulfills a unique mechanical function consisting, on the one hand, in containing the substantially liquid or pasty biopharmaceutical product by accommodating the forces resulting from its presence in the interior space of the pocket and its direct contact with its inner face, on the other hand, to support the at least one port and if necessary the at least one functional device.
• the development of the biopharmaceutical product in the pouch assembly utilizes or generates one or more functionally intrinsic bodies to the biopharmaceutical product as part of its development, i.e., part of the biopharmaceutical product or a component thereof. or used for the development of the biopharmaceutical product or generated on this occasion.
• a body is here described as an incidental body.
• Such an incidental body is such that:
• Such a body is solid and of small size or liquid (including pasty), in any case is not gaseous, is meant by “solid”, to present a certain cohesion or a certain consistency and to be neither neither liquid nor gaseous.
• a toxin or a microorganism falls within the definition of solid.
• small size is meant a dimension of the order of or less than or substantially less than one millimeter, up to molecular size.
• Such a body, if solid, is unitary or fractionated into a plurality, more especially a large multiplicity, of units or pieces. Therefore, although such a body is solid, one can qualify a biopharmaceutical product that contains it as being in substantially liquid or pasty form. Therefore, the term "biopharmaceutical” product in “substantially” liquid or pasty form, the fact that the biopharmaceutical product is very dominant and predominant quantitatively, in liquid or pasty form, even when it comprises within it such a solid body .
• Such an incidental body can be varied in terms of its substance, its nature, its structure, its composition, its function, its origin, its properties, its utility or its harmfulness ... It may be for example a body forming part of the final composition of the biopharmaceutical product or entering into its original composition or active ingredients or waste or by-products of reaction or impurities or a catalyst, activator, regulator or toxin or an antibiotic or a body acting on one or more physico-biologico-chemical conditions of the biopharmaceutical product or one or more physico-biologico-chemical conditions prevailing in the pocket or antibodies, cells or bacteria.
• a pocket assembly for the development of biopharmaceutical products as known today, it is necessary to disregard such an incidental body, which is not always desirable or possible, or to implement an exogenous means to the pocket assembly - structural or functional - which is adapted to this body.
• a step and the device for introducing into the filled pocket of the biopharmaceutical product - or components of such a product or intermediate products of such a final product - such a body such as nutrient, antibiotic, active substance, catalyst, and / or a step and the evacuation device of the filled pocket of the biopharmaceutical product - or of components of such a product or intermediate products of such a final product - of such a body as undesirable or toxic substance.
• Such an introduction or evacuation device is for example a port that can be closed or opened as needed.
• Patches are known to be applied to the skin of a person, comprising one or more active substances released once the patch is applied to the skin for dermal or transdermal use.
• references can be made to EP-A-0278473, US 4557723, US 4638043, US 4752478 and US-A-2009/0142388.
• Oxygen scavengers are specifically intended for the packaging of food products in order to limit or prevent their oxidation and thus allow a longer shelf life.
• Such an oxygen absorber may be in the form of a bag or a pellet or a label introduced into the package next to the food product, or be included or associated with the packaging wall itself.
• WO 2008/084231 WO 2005/033676.
• moisture absorbers corrosion inhibitors, odor absorbers, gas emitters, antibacterial agents
• Such devices are well adapted to their own purpose but can not be applied to the case of the development of a biopharmaceutical product, as previously defined, in particular because the product concerned is in solid form and not not liquid or pasty, and / or that the device is for the preservation and not the elaboration of the product, and / or that the body concerned is in gaseous form and not solid or liquid (including pasty), and / or that the device acts not directly on the product concerned, but on its environment.
• the invention therefore aims to meet this need.
• the subject of the invention is a process for producing a biopharmaceutical product in substantially liquid or pasty form by a physicochemical-biological elaboration process, in which:
• a pocket assembly including a pocket defining an interior space capable of containing the biopharmaceutical product during its production process, limited by a continuous wall, flexible, waterproof, non-degradable, adapted to be in direct contact with its inside face with the biopharmaceutical product and containing it, and, associated with the pocket, at least one port, where appropriate at least one functional device,
• the non-fully developed biopharmaceutical product or components thereof are available and the pouch is filled, thereby constituting the contents of the pouch,
• the development process is carried out in and with the bag assembly, and during this process at least one incidental, solid and small or liquid body which is within the biopharmaceutical product is used or generated to at least a moment or step in the development process.
• ⁇ we have a pocket set chosen to incorporate a means of support and exchange: o formed by or integrated into the wall of the pocket or the at least one port or functional device, so as to be able to be accessible from the inside of the pocket and in direct physical contact with the contents of the pocket ,
• the solid incident body is unitary or is split into a plurality, more especially a large multiplicity, of units or pieces.
• the solid incident body is of a size of the order of or less than or substantially smaller than one millimeter, up to the molecular size.
• the pocket assembly is implemented so that the incident body is substantially displaced between the biopharmaceutical product and the carrier and exchange medium, in the direction from the first to the second or in the direction from second to first.
• the own means of support and exchange is functionally active in response to the value taken by at least one physico-biologico-chemical condition of the contents of the pocket or in response to the value taken by the variation of such a physico-biologico-chemical condition or in response to a dedicated activation operation of a physical, biological or chemical nature.
• the own means of support and exchange before filling with a content, is not loaded with the incident body or, conversely, is substantially loaded with the incident body.
• the own means of support and exchange is not loaded with an incident body or, conversely, is substantially charged with the incident body .
• the subject of the invention is a pocket assembly specially intended for implementing the process for producing a biopharmaceutical product in substantially liquid or pasty form which has just been described, including a pocket defining a space interior capable of containing the biopharmaceutical product during its production process, limited by a continuous wall, flexible, waterproof, non-degradable, adapted to be in direct contact with its inner face with the biopharmaceutical product and to contain it, and associated at the pocket, at least one port, if necessary at least one functional device.
• the pocket assembly incorporates a means of support and exchange:
• the pocket assembly implemented is such that the means of support and exchange are in direct physical contact with the contents of the pocket, and that the own means of support and exchange being functionally active, the body incident substantially passes between the one and the other means of support and exchange and the very heart of the contents of the pocket and is substantially loaded on the means of support and exchange when it is not located or should not be substantially within the biopharmaceutical product.
• the own means of support and exchange is constituted by or comprises a membrane or a coating or a surface treatment of the wall of the pocket or the at least one port or functional device, or a body of support and exchange, or a support and exchange compartment.
• the own means of support and exchange is located towards the inner face of the wall of the pocket or the at least one port or functional device that forms or integrates. According to the embodiments, the own means of support and exchange is located on the entire surface or only on a part of the surface of a face of the pocket or the at least one port or functional device that forms or integrates while being either localized or distributed on this surface.
• the pouch assembly having, during the process of developing the biopharmaceutical product, a lower part, an upper part and a middle part, according to embodiments, the own means of support and exchange is located at least in the lower part or at least in the lower part and in the middle part of the whole.
• a means of support and exchange has an exchange surface with the contents of the pocket during the process of developing the biopharmaceutical product which is more greater than, more especially significantly larger than, more especially of the order of a multiple of, the surface of the inner face of the wall of the pocket or the at least one port or functional device which forms or integrates, and which is in direct contact with the contents of the pocket, especially as a result of the constitution of the own means of support and exchange, or the wall of the pocket or the at least one port or functional device which forms it or to which it is integrated or the configuration of the own means of support and exchange on the wall of the pocket or the at least one port or functional device which forms or integrates it.
• the pocket is a 2D pocket or a 3D pocket.
• the invention also relates to a pocket assembly before filling with a content in which, according to the embodiments, the own support and exchange means is not loaded with the incident body or, conversely, is substantially charged with the incident body.
• the invention also relates to a pocket assembly filled with an elaborated biopharmaceutical product, in which, according to the embodiments, the own support and exchange means are not loaded with the incident body or, conversely , is substantially charged with the incident body.
• the invention also relates to an assembly comprising in the first place a pocket assembly as described in which the own support and exchange means is functionally active following an activation operation. dedicated and, secondly, means of activation of the means of support and exchange of physical, biological or chemical nature.
• the activation means are constituted by the biopharmaceutical product located in the interior space of the pocket assembly and having properties capable of activating the own means of support and exchange. In one embodiment, the activation means are located outside the pocket assembly.
• FIG. 1 is a schematic perspective view of a gusseted 3D pocket forming part of a pocket assembly specially designed for implementation of a process for producing a biopharmaceutical product in substantially liquid or pasty form according to the invention, the pocket assembly incorporating a means of support and exchange, while in the process of development biopharmaceutical product is used or generates at least one incident body and that we implement the pocket assembly so that the means of support and of exchange in direct physical contact with the contents of the pocket, and so that, the own means of support and exchange being functionally active, the incident body substantially passes between the one and the other of the own means of support and exchange and breast contents of the pocket, so that the incident body is substantially loaded on the means of support and exchange when it is not at or must not be substantially within of the biopharmaceutical product.
• FIG. 2 illustrates, on the one hand, the relative disposition of the means of support and exchange with respect to the pocket assembly and the contents of the pocket and, on the other hand, the two functions of the own means. support and exchange.
• FIG. 3 Figures 3 to 13 are eleven views, in cross section, on a larger scale illustrating different possible embodiments of the own means of support and exchange that the pocket assembly incorporates.
• the description refers to the definitions previously given with regard to the biopharmaceutical product P, its substantially liquid or pasty form, the process for producing such a biopharmaceutical product P, a 2D pocket or a 3D pocket, the incidental body C and for this product, qualification of solid and small, etc.
• a biopharmaceutical product P that is to say a product resulting from biotechnology - culture media, cell cultures , buffer solutions, artificial nutrition liquids, blood products and derivatives of blood products - or a pharmaceutical product or more generally a product for use in the medical field.
• a biopharmaceutical product P has the characteristic of being in substantially liquid or pasty form, being totally or at least very dominant and predominant quantitatively, in liquid or pasty form, even when, where appropriate, it comprises within it a solid body in very small quantity.
• the development of the biopharmaceutical product P consists of one or more phases of a physico-chemical-biological process during which the biopharmaceutical product P is wholly or partly manufactured until reaching the finished state allowing its direct use or a state semifinished for subsequent use, such as, for example, addition of one or more components, mixing, aeration, filtration, reaction, heating or cooling ...
• one or more incident bodies C is used or generated (which includes the case where it is used and generated).
• Such an incident body C is solid and of small size or liquid.
• an incident body C is of a mass and a volume of low to very low , and even minute in view of the mass and volume of the biopharmaceutical product P.
• Such an incident body C is solid and of small size, having a certain cohesion or a certain consistency or is liquid (including pasty), in any case not being gaseous, and having, if it is solid, a dimension of the order of, or less than, or substantially less than one millimeter, up to the molecular size, which means each unit or piece.
• such an incident body C if it is solid is unitary or fractionated into a plurality, more especially a large multiplicity, of units or pieces.
• Such an incidental body C is varied as regards its substance, its nature, its structure, its composition, its function, its origin, its properties, its utility or its harmfulness ... It is for example a body in the final composition of the biopharmaceutical product P or in its initial composition or active ingredients or waste or by-products of reaction or impurities or a catalyst, activator, regulator or a toxin or an antibiotic or a body acting on one or more physico-biologico-chemical conditions of the biopharmaceutical product P or one or more physico-biologico-chemical conditions prevailing in the pocket or antibodies, cells or bacteria.
• the pocket assembly 1 includes a pocket 2 which, according to the embodiments, is a so-called 3D gusseted pocket as shown in Figure 1, or a so-called 2D pocket, not shown.
• the pocket 2 defines an interior space 2a, able to contain the content of the pocket during the development of the biopharmaceutical product P, including the biopharmaceutical product P itself, during its development.
• the pocket 2 is limited by a wall 3, as a whole continuous, a plastic film. It is flexible, waterproof and non-degradable.
• the film forming the wall 3 is mono material or not, single layer or not. The, or each of the constituent materials of the film, is chosen from materials satisfying the requirements mentioned above, as well as the mechanical strength requirements.
• the wall 3 has an outer face 3a and an inner face 3b. By “outside” is meant, which is not located in the pocket 2 and “inside”, which is located in the pocket 2 and limits the interior space 2a.
• the bag 2 is adapted to be in direct contact by its inner face 3b with the contents of the bag 2, in particular the biopharmaceutical product P, and to contain it.
• the bag 2 is arranged to support at least one port 4, for example a filling port and a dump port.
• the term "port" means any means of communication between the outside and the inside of the pocket 2, which is open at one or more moments or in one or more stages when the communication is desired, or else is closed off.
• At least one functional device 5 such as mixing device, aeration, filtration, measurement (this list is not limiting), comprising a suitable organ such as that mixing propeller, aerator, filter, probe (this list is not limited either).
• a suitable organ such as that mixing propeller, aerator, filter, probe (this list is not limited either).
• Such an organ is, at least partly, placed in the interior space 2a of the pocket 2.
• the at least one port 4 or functional device 5 has, like the wall 3 of the bag 2, an inner face located in the pocket 2.
• the pocket assembly 1, at least during the development process of the biopharmaceutical product P, is arranged to have a lower part 2b, an upper part 2c and a middle part 2d.
• the bag 2 comprises one or a plurality of filling ports 4 in the upper part 2c (such as the port 4 shown in FIG. 12) and a emptying port 4 in the lower part 2b, and a functional device 5 mixing bottom 2b ( Figure 13).
• a plurality of filling ports 4 in the upper part 2c such as the port 4 shown in FIG. 12
• a emptying port 4 in the lower part 2b such as the port 4 shown in FIG. 12
• a functional device 5 mixing bottom 2b Figure 13
• the device for the development of the biopharmaceutical product P may comprise, if necessary, a rigid external receiving container in its own interior space of the pocket assembly 1.
• the pocket assembly 1 incorporates a means of support and exchange 6.
• incorporating means that the means 6 forms with the pocket assembly 1 a coherent assembly, in particular indissociable.
• Cylean means that the support and exchange functions which qualify the means 6 belong to it and characterize it.
• the own medium of support and exchange 6 is formed by or integrated in the wall 3 of the pocket 2 or the at least one port 4 or functional device 5. In doing so, the own means of support and exchange 6 is capable of being accessible from the interior space 2a of the bag 2 and in direct physical contact with the contents of the bag 2, in particular the biopharmaceutical product P.
• the own medium of support and exchange 6 is arranged so as to be functionally capable of being able to be loaded with an incident body C and to allow the passage of this incident body C between the one and the other of the own means of support and exchange 6 and the breast of the contents of the pocket 2.
• the means 6 is therefore able to provide a first function of being able to be loaded with the incident body C and, also, a second function of allowing the passage of the incident body C between the one and the other of the own means of support and exchange 6 and the breast of the contents of the bag 2, in particular the biopharmaceutical product P.
• charged means that the incident body C is carried or captured by or maintained or located on or assimilated or adsorbed or absorbed by the own support and exchange means 6, so that under normal conditions and without further intervention, it can not be disseminated or disseminated, at least substantially, out of the proper means of support and exchange 6 or its immediate proximity.
• passage is meant that the incident body C migrates and is displaced from the carrier and exchange means 6 or from its immediate proximity to the biopharmaceutical product P or to one or more of the components thereof, in the direction going from the first to the second (arrows F1 figure 2), or from the second to the first (arrows F2 figure 2). In the case where there are two (or more) incident bodies C1 and C2, they can “pass” in both directions (arrows F3 and F4 Figure 2).
• the own medium of support and exchange 6 is functionally active in itself, especially permanently, or consecutively to a dedicated activation operation, especially from a given moment.
• the process for producing the biopharmaceutical product P is such that a pocket assembly 1 as previously described and the non-fully developed biopharmaceutical product P or components thereof are available and filled in. the bag 2, then in particular empty, thereby constituting the contents of the bag 2.
• the development process is carried out in and with the pocket assembly 1, and during this process the incident body C is used or generated, or it is used or generated.
• the development process may consist in adding a component for example in finely divided solid form - from the outside of the bag 2 and via a port 4 - the contents in liquid or pasty form already in the bag 2 to have been placed previously and to mix the assembly by means of a functional device 5, here a mixer.
• the process generating for example waste here constituting the incident body C, it is necessary to remove them from the biopharmaceutical product P being developed. It is the dual function played by the own medium of support and exchange 6 that will capture the waste / incident body C, so that the biopharmaceutical product P finally developed is free.
• the bag assembly 1 is completely filled or it is only partially filled, towards its lower part 2b and or at least in the lower part 2b and in all or part of the middle part 2d.
• FIG. 2 which illustrates, on the one hand, the relative disposition of the own medium of support and exchange 6 with respect to the pocket assembly 1 and the contents of the pocket 2 and, on the other hand, on the one hand, the two functions of the own medium of support and exchange 6, the set of pocket 1 is implemented so that the own means of support and exchange 6 submerged at least partially by the contents of the pocket 2 or in direct physical contact with this content, in particular the biopharmaceutical product P, and so that the own medium of support and exchange 6 then being functionally active, the incident body C passes directly substantially between the two the own medium of support and exchange 6 and the breast of the contents of the bag 2, in particular the biopharmaceutical product P.
• the incident body C is substantially loaded on the own medium of support and exchange 6 when it is not at or must not be substantially within the biopharmaceutical product P, whereas at least one moment or stage of the development process, it is necessarily substantially within the biopharmaceutical product P.
• the incident body C is a waste produced within the biopharmaceutical product P during the production process and this waste is then captured by the own support and exchange means 6 while being isolated and separated from the biopharmaceutical product P.
• the incident body C is an activator of the development process of the biopharmaceutical product which is not present in it at the beginning of the process, but is there subsequently, released by the proper means. of support and exchange 6 on which it is originally loaded.
• the own medium of support and exchange 6 is constituted by, or comprises, a membrane (FIGS. 3, 5, 6, 7, 8) or a coating (FIG. 4) or a surface treatment (FIG. ) of the wall 3 of the pocket 2 (FIGS. 3 to 11) or of the at least one port 4 (FIG. 12) or functional device 5 (FIG. 13), or a support and exchange body (FIG. 10) , or a support and exchange compartment ( Figure 1 1).
• the own medium of support and exchange 6 is located towards the inner face 3b of the wall 3 of the pocket 2 (FIGS. 2 to 5 and 7 to 1 1) or of the at least one port 4 ( 12) or functional device 5 (FIG. 13) which forms or integrates it.
• the own means of support and exchange 6 can be located towards the outer face 3a of the wall 3 of the pocket 2 since it is able to be accessible from the internal space 2a of the bag 2 and in direct physical contact with the contents of the bag 2 ( Figure 6).
• the own medium of support and exchange 6 is located on the entire surface of the face of the wall 3 of the pocket 2 ( Figures 3 to 6, 8 and 9) or the at least one port 4 ( Figure 12) or functional device 5 ( Figure 13) which forms or integrates.
• the own medium of support and exchange 6 is located on a part of the surface of the face of the wall 3 of the pocket 2 or the at least one port 4 or functional device 5 which forms or integrates it being then located ( Figure 7) or distributed on this surface.
• the own means of support and exchange 6 is located in the lower part 2b of the pocket assembly 1 or in this lower part 2b and in all or part of the middle portion 2d.
• the own medium of support and exchange 6 is located in the lower part 2b of the pocket assembly 1 or in this lower part 2b and all or part of the middle part 2d.
• the own medium of support and exchange 6 can be located in the upper part 2c of the pocket assembly, as is the case s' it is located on a port 4 such as the port 4 shown in FIG. 12.
• the own medium of support and exchange 6 has an exchange surface with the content of the pocket 2 during the process of development of the biopharmaceutical product P which is greater than, more especially significantly greater than, more especially of the order of a multiple of, the surface of the inner face 3b of the wall 3 of the pocket 2 or the at least one port 4 or functional device 5 which forms or integrates it, and which is in direct contact with the contents of the pocket 2.
• the own medium of support and exchange 6 is active in itself, for example, because its nature allows it to capture or release the incident body C at any time and permanently, without requiring action for this purpose.
• the own medium of support and exchange 6 is not active in itself at any moment and permanently, but requires to be made active consecutively to a dedicated activation operation.
• the own carrier and exchange means 6 is made active in response to the value taken by at least one physico-biologico-chemical condition of the biopharmaceutical product P or at least one physico-biologico-chemical condition or existing in pocket 2.
• a physico-biologico-chemical condition is for example the temperature, the pH, the composition, the content of this or that body, the presence of this or that microorganism ...
• the own medium of support and exchange 6 is made active in response to the value of the physico-biologico-chemical condition as such, but in response to the variation of such a physical condition. biological-chemical.
• the own medium of support and exchange 6 is made active in response to a dedicated activation operation of a physical, biological or chemical nature, such as heat, agitation ...
• a dedicated activation operation of a physical, biological or chemical nature such as heat, agitation ...
• means for activating the own means of support and exchange 6 of physical, biological or chemical nature which are structurally distinct from the pocket assembly 1 but intended to be functionally associated with it at the time of the invention.
• activation of the own medium of support and exchange 6 are constituted by the biopharmaceutical product P having properties of a physical, biological or chemical nature capable of activating the own means of support and exchange .
• these activation means are located outside the pocket assembly 1 or in the interior space 2a, when, for example, they consist of the biopharmaceutical product P.
• the own means of support and exchange 6 is formed by a layer 7 completely and continuously coating the inner face 3b of the film of the wall 3 or the wall 3 itself.
• the own medium of support and exchange 6 has an exchange surface with the biopharmaceutical product P during its preparation and / or its conservation which is substantially equal to the surface of the inner face 3b of the bag 2 of the pocket assembly 1.
• the own support and exchange means 6 is formed by a continuous coating 8 on the whole of the inner face 3b of the film of the wall 3 or of the wall 3 itself.
• the own support and exchange means 6 is formed by a continuous layer 9 sandwiched between the outer face 3a and the inner face 3b of the film of the wall 3 or of the wall 3. even on the whole surface of it, respectively this one.
• the own means of support and exchange 6 is formed by a layer 10 completely and continuously coating the outer face 3a of the film of the wall 3 or of the wall 3 itself, the film of the wall 3 or the wall 3 itself then being able to allow the exchange of the incident body C, in all its thickness, from the interior space 2a of the pocket 2 to the outside, or vice versa.
• the own medium of support and exchange 6 is formed by a layer 11 forming a kind of patch (or "patch") 11 locally covering the inner face 3b of the film of the wall 3 or of the wall 3 itself.
• patch or "patch”
• the own means of support and exchange 6 is or comprises a membrane 12 more or less body with the film of the wall 3 or the wall 3 itself, on the inner face 3b.
• the membrane can be folded more or less significantly on itself.
• the own means of support and exchange 6 is formed by anfractuosities 13 or an irregular surface state with cavities or cavities of the film of the wall 3, obtained by particle bombardment, etching.
• the own medium of support and exchange 6 has, by the very fact of the configuration which is given to it, an exchange surface with the biopharmaceutical product P during its elaboration greater than the surface. of the inner face 3b of the pocket 2.
• the own medium of support and exchange 6 may have an exchange surface of the order of several or even a large number of times, the surface of the inner face 3b of the pocket 2.
• the own support and exchange means 6 is a solid body 14, for example carried by the film of the wall 3 or by the wall 3 itself, on or towards the inside face 3b.
• the own medium of support and exchange 6 has, in itself, an exchange surface with the biopharmaceutical product P during its elaboration greater than the surface of the inner face 3b of the bag 2
• the means 6 may have an exchange surface of the order of several or even a large number of times the surface of the inner face 3b of the pocket 2.
• the own means of support and exchange 6 is constituted by a compartment 15 limited by a wall 16 allowing the exchange between the inside and the outside of the compartment 16.
• the means of support and exchange 6 occupies the entire surface or only a portion of the surface of the film of the wall 3 or the wall 3 itself being either located or distributed with respect to this surface.
• the own medium of support and exchange 6 is formed by or integrated with a port 4, while being as previously able to be accessible from the inside space 2a of the pocket 2 and in contact direct physicality with the contents of the pocket 2,
• This realization includes the case where the own medium of support and exchange 6 is formed by or integrated not directly to the port 4 itself, but indirectly, namely to an organ to support the port 4.
• the own medium of support and exchange 6 is formed by or integrated with a functional device 5, while being as previously able to be accessible from the inside space 2a of the pocket 2 and in direct physical contact with the contents of the bag 2,
• This embodiment includes the case where the own means of support and exchange 6 is formed by or integrated not directly to the functional device 5 itself, but indirectly, namely to an organ to support the functional device 5.
• the production method and the pocket assembly 1 may be the subject of several different embodiments with respect to the moment when the own medium of support and exchange 6 is loaded with the incident body C and the moment when it It is not loaded with the incident body C and this with regard to the moment before filling of the pocket 2 and once the biopharmaceutical product P elaborated.
• the own medium of support and exchange 6 is not loaded with the incident body C.
• the own medium of support and exchange 6 prior to filling with a content, is substantially loaded with the incident body C. In one embodiment, after the biopharmaceutical product P has been developed, the own means of support and exchange 6 is not loaded with the incident body C.
• the own carrier and exchange means 6 is substantially charged with the incident body C.
• the own medium of support and exchange 6 is not loaded with the incident body C and after the biopharmaceutical product P has been developed, on the contrary, it is loaded with the incident body C.
• This embodiment applies, for example, with an incident body C which is an undesirable body that does not exist at the beginning of the process for producing the biopharmaceutical product P, but produces during this process the elaboration and which it is desired to eliminate from the very bosom of the product. biopharmaceutical product P.
• the own medium of support and exchange 6 before filling the bag 2, is substantially loaded with the incident body C and after the biopharmaceutical product P has been developed, on the contrary, it is not responsible for the incident body C.
• This embodiment applies for example with a body C can then be an incident body necessary to the process of development of the biopharmaceutical product P, existing at the beginning of the development process, consumed during this process and non-existent at the end.

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• Health & Medical Sciences (AREA)
• Organic Chemistry (AREA)
• Wood Science & Technology (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Zoology (AREA)
• Chemical & Material Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Engineering & Computer Science (AREA)
• Genetics & Genomics (AREA)
• Biochemistry (AREA)
• General Engineering & Computer Science (AREA)
• General Health & Medical Sciences (AREA)
• Sustainable Development (AREA)
• Microbiology (AREA)
• Biotechnology (AREA)
• Biomedical Technology (AREA)
• Clinical Laboratory Science (AREA)
• Packages (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• Basic Packing Technique (AREA)
• Bag Frames (AREA)

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Citations (6)

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• 2009
  • 2009-10-02 FR FR0956889A patent/FR2950802B1/fr active Active
• 2010
  • 2010-09-29 US US13/499,738 patent/US20120193264A1/en not_active Abandoned
  • 2010-09-29 EP EP10773658A patent/EP2483385A2/de not_active Withdrawn
  • 2010-09-29 WO PCT/FR2010/052048 patent/WO2011039472A2/fr active Application Filing

Patent Citations (6)

Non-Patent Citations (1)

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