Production of a biopharmaceutical product

Abstract

Process of producing a biopharmaceutical product includes providing a pouch unit including a pouch and at least one port, and optionally, a functional device; filling the pouch with the product; carrying out the production process, and at at least one stage thereof, using or generating a liquid or small solid incident body within the biopharmaceutical product; the pouch unit incorporating a support and replacement element formed by or integrated in the pouch wall, or in the port or functional device so as to be accessible from the inside space and be in direct physical contact with the contents of the pouch, arranged so as to be able to be loaded with the incident body and pass between the support and replacement element and the contents, such that the incident body is loaded on the support and replacement element when it is not or should not be within the biopharmaceutical product.

1 - 27 . (canceled) 
     
     
         28 . Process for the production of a biopharmaceutical product in substantially liquid or paste form by a physical-chemical-biological production process, in which:
 A pouch unit ( 1 ) is provided that includes a pouch ( 2 ) that defines an inside space ( 2   a ) that can contain the biopharmaceutical product during its production process, and said pouch unit is limited by a continuous wall ( 3 ) that is flexible, airtight, and non-degradable, and that can be in direct contact by its inside face ( 3   b ) with the biopharmaceutical product and can contain it, and, combined with the pouch ( 2 ), at least one port ( 4 ), and, if necessary, at least one functional device ( 5 ),   The biopharmaceutical product that is not totally finished or components of the latter is/are provided, and the pouch ( 2 ) is filled with said product or components, thus constituting the contents of the pouch ( 2 ),   The process for production is implemented in and with the pouch unit ( 1 ), and during this process, at least one incident body that is solid and small in size or liquid that is within the biopharmaceutical product is used or generated at at least one time or stage of the production process,   
       characterized by the fact that:
 The at least one incident body that is solid and that is broken into a number, more specially a large number, of units or pieces of a dimension on the order of, or less than, or significantly less than, a millimeter, down to molecular size, is generated, 
 A pouch unit ( 1 ) that is selected for incorporating an inherent means of support and replacement ( 6 ) is provided:
 Formed by or integrated in the wall ( 3 ) of the pouch ( 2 ) or in at least one port ( 4 ) or functional device ( 5 ), in such a way as to be able to be accessible from the inside space ( 2   a ) of the pouch ( 2 ) and in direct physical contact with the contents of the pouch ( 2 ), 
 Arranged in such a way as to be functionally able to be loaded with the incident body and to make possible the passage of the incident body between one and the other of the inherent means of support and replacement ( 6 ) and within the contents of the pouch ( 2 ), 
 Being functionally active per se or as a consequence of a dedicated activation operation, 
 
 The pouch unit ( 1 ) is used in such a way that the inherent means of support and replacement ( 6 ) is in direct physical contact with the contents of the pouch ( 2 ) and in such a way that with the inherent means of support and replacement ( 6 ) being functionally active, the incident body passes substantially between one and the other of the inherent means of support and replacement ( 6 ) and within the contents of the pouch ( 2 ) in such a way that the incident body is substantially loaded on the inherent means of support and replacement ( 6 ) when it is not or should not be substantially within the biopharmaceutical product. 
 
     
     
         29 . Process according to  claim 28 , wherein the inherent means of support and replacement ( 6 ) is functionally active in response to the value taken on by at least one physical-biological-chemical condition of the contents of the pouch ( 2 ) or in response to the value taken on by the variation of such a physical-biological-chemical condition or in response to a dedicated activation operation of a physical, biological, or chemical nature. 
     
     
         30 . Process according to  claim 28 , wherein once the biopharmaceutical product has been produced and is in the pouch ( 2 ), the inherent means of support and replacement ( 6 ) is substantially loaded with the incident body, whereas before filling with contents, the inherent means of support and replacement ( 6 ) is not loaded with the incident body. 
     
     
         31 . Process according to  claim 28 , wherein before filling with contents, the inherent means of support and replacement ( 6 ) is substantially loaded with the incident body, whereas once the biopharmaceutical product has been produced and is in the pouch ( 2 ), the inherent means of support and replacement ( 6 ) is not loaded with the incident body. 
     
     
         32 . Pouch unit ( 1 ) that is specially designed for the implementation of the process for the production of a biopharmaceutical product in substantially liquid or paste form according to  claim 28 , including a pouch ( 2 ) that defines an inside space ( 2   a ) that can contain the biopharmaceutical product during its production process, limited by a continuous wall ( 3 ) that is flexible, airtight, and non-degradable, and that can be in direct contact by its inside face ( 3   b ) with the biopharmaceutical product and can contain it, and, combined with the pouch ( 2 ), at least one port ( 4 ), and if necessary at least one functional device ( 5 ), which:
 Incorporates an inherent means of support and replacement ( 6 ):
 Formed by or integrated in the wall ( 3 ) of the pouch ( 2 ) or in at least one port ( 4 ) or functional device ( 5 ), in such a way as to be able to be accessible from the inside space ( 2   a ) of the pouch ( 2 ) and in direct physical contact with the contents of the pouch ( 2 ), 
 Arranged in such a way as to be functionally able to be loaded with the incident body and to make possible the passage of the incident body between one and the other of the inherent means of support and replacement ( 6 ) and within the contents of the pouch ( 2 ) itself, 
 Functionally active per se or as a consequence of a dedicated activation operation, 
   Is implemented such that the inherent means of support and replacement ( 6 ) is in direct physical contact with the contents of the pouch ( 2 ) and such that, with the inherent means of support and replacement ( 6 ) being functionally active, the incident body passes substantially between one and the other of the inherent means of support and replacement ( 6 ) and within the contents of the pouch ( 2 ) itself, and is substantially loaded on the inherent means of support and replacement ( 6 ) when it is not or should not be substantially within the biopharmaceutical product.   
     
     
         33 . Pouch unit ( 1 ) according to  claim 32 , wherein the inherent means of support and replacement ( 6 ) consists of or comprises a membrane or a coating or a surface treatment of the wall ( 3 ) of the pouch ( 2 ) or at least one port ( 4 ) or functional device ( 5 ), or a body of support and replacement, or a compartment of support and replacement. 
     
     
         34 . Pouch unit ( 1 ) according to  claim 32 , wherein the inherent means of support and replacement ( 6 ) is located toward the inside face ( 3   b ) of the wall ( 3 ) of the pouch ( 2 ) or at least one port ( 4 ) or functional device ( 5 ) that forms it or integrates it. 
     
     
         35 . Pouch unit ( 1 ) according to  claim 32 , wherein the inherent means of support and replacement ( 6 ) is located over the entire surface or on only one portion of the surface of a face of the pouch ( 2 ) or at least one port ( 4 ) or functional device ( 5 ) that forms it or integrates it by then being either located or distributed over this face. 
     
     
         36 . Pouch unit ( 1 ) according to  claim 32 , that has, during the process for the production of the biopharmaceutical product, a lower part ( 2   b ), an upper part ( 2   c ), and a median part ( 2   d ), wherein the inherent means of support and replacement ( 6 ) is located at least in the lower part ( 2   b ) or at least in the lower part ( 2   b ) and in all or part of the median part ( 2   d ) of the pouch unit ( 1 ). 
     
     
         37 . Pouch unit ( 1 ) according to  claim 32 , characterized by an inherent means of support and replacement ( 6 ) that has a surface area for replacement with the contents of the pouch ( 2 ) during the process for the production of the biopharmaceutical product that is larger than, more specially significantly larger than, more specially on the order of a multiple of, the surface area of the inside face ( 3   b ) of the wall ( 3 ) of the pouch ( 2 ) or at least one port ( 4 ) or functional device ( 5 ) that forms it or integrates it, and that is in direct contact with the contents of the pouch ( 2 ), as a result of the composition of the inherent means of support and replacement ( 6 ), or the wall ( 3 ) of the pouch ( 2 ) or at least one port ( 4 ) or functional device ( 5 ) that forms it or in which it is integrated or the configuration of the inherent means of support and replacement ( 6 ) on the wall ( 3 ) of the pouch ( 2 ) or at least one port ( 4 ) or functional device ( 5 ) that forms it or in which it is integrated. 
     
     
         38 . Pouch unit ( 1 ) according to  claim 32 , wherein the inherent means of support and replacement ( 6 ) is functionally active in response to the value taken on by at least one physical-biological-chemical condition of the contents of the pouch ( 2 ) or in response to the value taken on by the variation of such a physical-biological-chemical condition or in response to a dedicated activation operation of a physical, biological, or chemical nature. 
     
     
         39 . Pouch unit ( 1 ) according to  claim 32 , wherein the pouch ( 2 ) is either a 2D pouch or a 3D pouch. 
     
     
         40 . Pouch unit ( 1 ) according to  claim 32  before filling with contents, wherein the inherent means of support and replacement ( 6 ) is not loaded with the incident body. 
     
     
         41 . Pouch unit ( 1 ) according to  claim 32  before filling with contents, wherein the inherent means of support and replacement ( 6 ) is substantially loaded with the incident body. 
     
     
         42 . Pouch unit ( 1 ) according to  claim 32  that is filled with finished biopharmaceutical product, wherein the inherent means of support and replacement ( 6 ) is not loaded with the incident body. 
     
     
         43 . Pouch unit ( 1 ) according to  claim 32  that is filled with finished biopharmaceutical product, wherein the inherent means of support and replacement ( 6 ) is substantially loaded with the incident body. 
     
     
         44 . Unit that comprises, in the first place, a pouch unit ( 1 ) according to  claim 32 , wherein the inherent means of support and replacement ( 6 ) is functionally active as a consequence of a dedicated activation operation, and, in the second place, means of activation of the inherent means of support and replacement ( 6 ) of a physical, biological or chemical nature. 
     
     
         45 . Unit according to  claim 44 , wherein the activation means either consist of the biopharmaceutical product P that is in the inside space ( 2   a ) of the pouch unit ( 1 ) and that has properties that can activate the inherent means of support and replacement ( 6 ) or are located outside of the pouch unit ( 1 ).