Method and apparatus for producing a biomaterial product

Abstract

A development tool 2 includes a plurality of measuring tools 71 to 76 and an industrial process simulation device 60 . The simulation device 60 simulates a whole industrial scale bioprocess in order to obtain acceptable operating parameters for the industrial scale bioprocess. The measuring tools 71 to 76 enable various significant properties of the biomaterial to be measured and evaluated using only a small test quantity of the biomaterial.

1 - 36 . (canceled)  
   
   
       37 . A system for deriving values defining design and/or operating parameters for at least one stage of a multiple stage industrial or pilot scale bioprocess for obtaining a product, said system comprising: 
 (a) a biomaterial;    (b) simulating means for subjecting a test quantity of said biomaterial or a derivative thereof to conditions which simulate one or more features of an industrial scale device engineering environment that affect biomaterial properties;    (c) means for measuring the effects of said simulated conditions on said biomaterial or derivative; and    (d) a computer simulation device for modelling the effects of said at least one stage on the properties of said biomaterial and for deriving values defining design and/or operating parameters for at least said at least one stage that achieve a predetermined quality and yield of said product;    wherein said test quantity of biomaterial or derivative subjected to the conditions of simulating means (b) has a composition and physical properties substantially corresponding to those which would occur in a corresponding stage of an industrial or pilot scale bioprocess.    
   
   
       38 . A system as claimed in  claim 37  wherein the computer simulation device includes modelling means for modelling the effects of at least one industrial device on biomaterial which is processed by the device, wherein said modelling means includes means for determining the amount of shear stress inflicted on the biomaterial as a function of one or more operating conditions of the device.  
   
   
       39 . A system as claimed in  claim 38  wherein the modelling means is arranged to model the effects of an industrial centrifuge.  
   
   
       40 . A system as claimed in  claim 38  wherein the modelling means is arranged to model the effects of an industrial pump.  
   
   
       41 . A system as claimed in  claim 38  wherein the modelling means is arranged to model the effects of a microfiltration device.  
   
   
       42 . A system as claimed in  claim 37  wherein said computer simulation device includes modelling means for modelling the effects of a biomaterial on the performance of at least one industrial device when said industrial device interacts with the biomaterial.  
   
   
       43 . A system as claimed in  claim 42  wherein said modelling means is operable to model the deviation from ideal performance of an industrial device as a function of the biomaterial or a property thereof.  
   
   
       44 . A system as claimed in  claim 42  wherein said modelling means is adapted to model the degree of fouling of an industrial chromatography column.  
   
   
       45 . A system as claimed in  claim 37  wherein said computer simulation device includes modelling means for modelling the effects of an industrial centrifuge on biomaterial which comprises a liquid component and a solid component suspended within the liquid component and which is centrifuged by the device, said modelling means including means for determining the amount of the liquid component which is emptied from a holding portion of the centrifuge with solid material, said amount of liquid component being determined as a function of the properties of the biomaterial and the properties and operating conditions of the industrial centrifuge.  
   
   
       46 . A system as claimed in  claim 45  wherein the determining means is further adapted to determine the amount of the solid component which is passed through the centrifuge instead of being emptied from said holding portion.  
   
   
       47 . A system as claimed in  claim 37  including a display and display control means, wherein the display control means is adapted to display results determined by the simulation device in a graphical form in which combinations of values of operating conditions that give rise to a predetermined effect, as determined by the simulation device, are illustrated in a first manner and combinations of values of operating conditions that do not give rise to the predetermined effect are illustrated in a second manner which is visually distinguishable from the first manner.  
   
   
       48 . Apparatus for deriving values defining design and/or operating parameters for at least one stage of a multiple stage industrial or pilot scale bioprocess for obtaining a product, said system comprising: 
 (a) simulating means for subjecting a test quantity of said biomaterial or a derivative thereof to conditions which simulate one or more features of an industrial scale device engineering environment that affect biomaterial properties;    (b) means for measuring the effects of said simulated conditions on said biomaterial or derivative; and    (c) a computer simulation device for modelling the effects of said at least one stage on the properties of said biomaterial and for deriving values defining design and/or operating parameters for at least said at least one stage that achieve a predetermined quality and yield of said product;    characterised in that said simulating means comprises a rotating disk device operable to simulate the shear conditions encountered in an industrial centrifuge.    
   
   
       49 . Apparatus as claimed in  claim 48  wherein the rotating disk device comprises a disk rotatably mounted within a chamber and adapted to subject material placed in said chamber to shear upon rotation of said disk.  
   
   
       50 . Apparatus as claimed in  claim 48  wherein the rotating disk device has a lid with a conical taper.  
   
   
       51 . Apparatus as claimed in  claim 48  wherein the disk is mounted on a spindle operably attached to a rotor of a motor.  
   
   
       52 . Apparatus as claimed in  claim 51  wherein the motor includes a speed detector for detecting the rotational speed of the rotor.  
   
   
       53 . Apparatus as claimed in  claim 51  wherein the motor is a direct current electric motor.  
   
   
       54 . Apparatus as claimed in  claim 48  wherein the computer simulation device includes modelling means for modelling the effects of at least one industrial device on biomaterial which is processed by the device, wherein said modelling means includes means for determining the amount of shear stress inflicted on the biomaterial as a function of one or more operating conditions of the device.  
   
   
       55 . Apparatus as claimed in  claim 54  wherein the modelling means is arranged to model the effects of an industrial centrifuge.  
   
   
       56 . Apparatus as claimed in  claim 54  wherein the modelling means is arranged to model the effects of an industrial pump.  
   
   
       57 . Apparatus as claimed in  claim 54  wherein the modelling means is arranged to model the effects of a microfiltration device.  
   
   
       58 . Apparatus as claimed in  claim 48  wherein said computer simulation device includes modelling means for modelling the effects of a biomaterial on the performance of at least one industrial device when said industrial device interacts with the biomaterial.  
   
   
       59 . Apparatus as claimed in  claim 58  wherein said modelling means is operable to model the deviation from ideal performance of an industrial device as a function of the biomaterial or a property thereof.  
   
   
       60 . Apparatus as claimed in  claim 58  wherein said modelling means is adapted to model the degree of fouling of an industrial chromatography column.  
   
   
       61 . Apparatus as claimed in  claim 48  wherein said computer simulation device includes modelling means for modelling the effects of an industrial centrifuge on biomaterial which comprises a liquid component and a solid component suspended within the liquid component and which is centrifuged by the device, said modelling means including means for determining the amount of the liquid component which is emptied from a holding portion of the centrifuge with solid material, said amount of liquid component being determined as a function of the properties of the biomaterial and the properties and operating conditions of the industrial centrifuge.  
   
   
       62 . Apparatus as claimed in  claim 61  wherein the determining means is further adapted to determine the amount of the solid component which is passed through the centrifuge instead of being emptied from said holding portion.  
   
   
       63 . Apparatus as claimed in  claim 48  including a display and display control means, wherein the display control means is adapted to display results determined by the simulation device in a graphical form in which combinations of values of operating conditions that give rise to a predetermined effect, as determined by the simulation device, are illustrated in a first manner and combinations of values of operating conditions that do not give rise to the predetermined effect are illustrated in a second manner which is visually distinguishable from the first manner.  
   
   
       64 . A computer program comprising: 
 means defining an input data structure for storing, in a computer, input data corresponding to measurements of the effects of subjecting a test quantity of biomaterial, or a derivative thereof, similar in composition and physical properties to biomaterial that would be obtained in an industrial or pilot scale bioprocess to conditions which simulate one or more features of an industrial scale device engineering environment that affect biomaterial properties, and    means for causing a computer to perform modelling utilising said input data stored in said input data structure to derive output data defining design and/or operating parameters for at least one stage of a multiple stage industrial or pilot scale bioprocess.    
   
   
       65 . A computer program according to  claim 64  comprising a plurality of modelling modules each for modelling a respective one of said stages of said bioprocess and at least one of said modules comprising computer executable instructions defining: 
 a first input data structure for inputting to said at least one module biomaterial parameters defining measured properties of a biomaterial obtained from a preceding stage or a succeeding stage of said bioprocess;    a second input data structure for inputting to said at least one module operational parameters defining the operation of said stage;    a third input data structure for inputting to said at least one module additional parameters defining measured properties of a test quantity of biomaterial subjected to conditions which simulate one or more features of an industrial scale device engineering environment that affect biomaterial properties; and    a processing operation which models the operation of said stage utilising said parameters input in accordance with said first, second and third input data structures to produce output data representing parameters of the biomaterial which would be produced by said stage when operated, in accordance with said operational parameters, in an industrial or pilot scale bioprocess.    
   
   
       66 . Computer apparatus for generating data defining the design and/or operating characteristics of a bioprocessing plant for producing a product, the computer apparatus being programmed to operate in accordance with the computer program of  claim 64 .  
   
   
       67 . Computer apparatus for generating data defining the design and/or operating characteristics of a bioprocessing plant for producing a product, the computer apparatus being programmed to operate in accordance with a plurality of computer programs according to  claim 64 , wherein each computer program is adapted to model the effects on a biomaterial of a single device or stage within the plant.  
   
   
       68 . Computer apparatus as claimed in  claim 67  wherein the computer programs are in communication such that at least one of the programs is capable of receiving data from an upstream or downstream computer program.  
   
   
       69 . A carrier medium carrying the computer program of  claim 64 .  
   
   
       70 . A carrier medium carrying the computer program of  claim 65.