Bioprocess method and system

Abstract

Methods, systems and apparatus for performing a biological process are provided, wherein the method comprises implementation of at least one unit operation, and wherein the unit operation is defined according to a standardized element structure, the element structure comprising a plurality of functional section blocks, and wherein the section blocks comprise at least one of the group consisting of: imports; parameters; data; physical inputs; requirements; setup; and execution steps.

1 . A system for performing a biological process that includes a step involving one or more of a reproducible and scalable transformation of a material into a physical product or a quantification of an amount of a molecule in the material, the system comprising:
 (i) a server with at least one processing module adapted to implement a method for performing the biological process wherein the method comprises implementation of at least one unit operation, and wherein the at least one unit operation is defined according to a standardized element structure, the standardized element structure comprising a plurality of functional section blocks, and wherein the plurality of functional section blocks comprises at least one of the group consisting of: imports; parameters; data; physical inputs; requirements; setup; and execution steps;   (i) a data storing mechanism which is accessible by the at least one processing module for maintaining a record of standardized elements, wherein each standardized element defines a unit operation in a biological process; and   (ii) a first interface for accessing the method.   
     
     
         2 . The system of  claim 1 , further comprising a second interface for controlling an automated laboratory equipment to implement the at least one unit operation of the biological process to perform the reproducible and scalable transformation of the material into a physical product. 
     
     
         3 . The system of  claim 1 , wherein the at least one unit operation is a self-contained process of the biological process and the standardized element structure comprises a structure of a combination of elements that are each reproducible and scalable in a plurality of workflows including a workflow to perform the biological process. 
     
     
         4 . The system of  claim 1 , wherein the data storing mechanism comprises a database. 
     
     
         5 . The system of  claim 1 , wherein the method is provided through a cloud service. 
     
     
         6 . The system of  claim 1 , wherein the system comprises a website or a mobile device or computer application to access the method. 
     
     
         7 . The system of  claim 1 , wherein the system is incorporated as part of a laboratory information management system (LIMS). 
     
     
         8 . The system of  claim 1 , wherein the standardized element structure further comprises at least one additional section block selected from the group consisting of:
 physical outputs; analysis; and validation steps.   
     
     
         9 . The system of  claim 1  wherein the standardized element structure comprises at least section blocks defining: imports; parameters; data; physical inputs;
 requirements; setup; and execution steps. 
 
     
     
         10 . The system of  claim 1 , wherein the biological process comprises at least two unit operations, wherein each unit operation is defined according to a standardized element structure. 
     
     
         11 . The system of  claim 10 , wherein the at least two unit operations are non-identical. 
     
     
         12 . The system of  claim 1 , wherein the at least one unit operation is selected from the group consisting of: a conversion; a reaction; a purification; a construct assembly step; an assay or analysis including any of a quantification of a product, a by-product or reagent; a nucleotide or protein/peptide synthesis; a cell culture; an incubation; a restriction; a ligation; a mutation; an inoculation; a lysis; a transformation; an extraction; conditioning of a product; and an amplification. 
     
     
         13 . The system of  claim 1 , wherein the biological process comprises a manufacturing process. 
     
     
         14 . The system of  claim 1 , wherein the biological process comprises an analytical process. 
     
     
         15 . A system for designing an experiment, the system comprising:
 (i) a server with at least one processing module adapted to implement a method for designing the experiment, wherein the method comprises determining a reproducible and scalable biological process for conversion of a selected input to a desired output, wherein the reproducible and scalable process comprises at least one unit operation selected from a database that comprises at least one unit operation, and wherein the at least one unit operation is defined according to a standardized element structure, the standardized element structure comprising a plurality of functional section blocks, and wherein the plurality of functional section blocks comprises at least one of the group consisting of: imports; parameters; data; physical inputs; requirements; setup; and execution steps;   (ii) a data storing mechanism which is accessible by the at least one processing module for maintaining a record of standardized elements, wherein each standardized element defines a unit operation in a biological process; and   (iii) at least a first interface for a user to choose the selected input and the desired output for the experiment, wherein the selected input comprises physical input and the desired output is selected from either or both a physical output and information output.   
     
     
         16 . The system of  claim 15 , further comprising a second interface for controlling an automated laboratory equipment to implement the at least one unit operation of the biological process to perform the reproducible and scalable transformation of a material into a physical product. 
     
     
         17 . The system of  claim 15 , wherein the at least one unit operation is a self-contained process of the biological process and the standardized element structure is a structure of a combination of elements that are each reproducible and scalable in a plurality of workflows including a workflow to perform the biological process. 
     
     
         18 . The system of  claim 15 , wherein the data storing mechanism is a database. 
     
     
         19 . The system of  claim 15 , wherein the method is provided through a cloud service. 
     
     
         20 . The system of  claim 15 , wherein the system comprises a website or a mobile device or computer application to access the method. 
     
     
         21 . The system of  claim 15 , wherein the system is incorporated as part of a laboratory information management system (LIMS).