Microscale bioprocessing system and method for protein manufacturing

Abstract

A bioprocessing system for protein manufacturing is provided that is compact, integrated and suited for on-demand production and delivery of therapeutic proteins to patients. The system can also be used for efficient on-demand production of any type of protein.

What is claimed is: 
     
         1 . A bioprocessing system, comprising:
 a reactor for protein expression;   a membrane chromatography component for receiving and purifying protein output by the reactor; and   a diafiltration component for receiving purified protein from the membrane chromatography and for further purifying the purified protein.   
     
     
         2 . The system of  claim 1 , wherein the reactor is adapted for cell-free protein expression. 
     
     
         3 . The system of  claim 2 , wherein the reactor has a capacity of approximately 20 ml or less and the membrane chromatography component has a capacity of less than approximately 5 ml. 
     
     
         4 . The system of  claim 1 , wherein the diafiltration component comprises:
 a product section for receiving purified protein from the membrane chromatography component; and   a buffer section for receiving a buffer solution.   
     
     
         5 . The system of  claim 4 , wherein the diafiltration component comprises:
 a first substrate;   a second substrate; and   a diafiltration membrane positioned between the first and second substrates.   
     
     
         6 . The system of  claim 5 , wherein the product section comprises a serpentine-shaped channel formed on the first substrate and the buffer section comprises a serpentine-shaped channel formed on the second substrate, wherein the first and second serpentine-shaped channels substantially overlap each other. 
     
     
         7 . The system of  claim 4 , wherein the diafiltration component comprises a flow cell. 
     
     
         8 . The system of  claim 7 , wherein the product section comprises tubing positioned within the flow cell and the diafiltration membrane comprises the tubing material. 
     
     
         9 . The system of  claim 1 , wherein the reactor comprises at least one sensor for monitoring reaction parameters. 
     
     
         10 . The system of  claim 9 , wherein the at least one sensor monitors at least one of conductivity, temperature, pH, oxygen and CO 2 .