MICROSCALE BIOPROCESSING SYSTEM AND METHOD FOR PROTEIN MANUFACTURING FROM HUMAN BLOOD
A bioprocessing system for protein manufacturing from human blood is provided that is compact, integrated and suited for on-demand production and delivery of therapeutic proteins to patients. The patient's own blood can be used as the source of cell extracts for the production of the therapeutic proteins.
1 . A bioprocessing system, comprising:
a production module for producing a protein from cells extracted from blood; and
a purification module for receiving the protein from the production module and for purifying the protein from reagents.
2 . The system of claim 1 , wherein the production module has a capacity of approximately 20 ml or less.
3 . The system of claim 1 , wherein the purification module comprises:
a chromatography component for receiving the protein from the production module and for outputting purified protein; and
a diafiltration component for receiving the purified protein from the membrane chromatography component and for outputting further purified protein.
4 . The system of claim 3 , wherein the chromatography component comprises a membrane chromatography component.
5 . The system of claim 3 , wherein the chromatography component comprises a column chromatography component.
6 . The system of claim 3 , 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.
7 . The system of claim 6 , wherein the diafiltration component comprises:
a first substrate;
a second substrate; and
a diafiltration membrane positioned between the first and second substrates.
8 . The system of claim 7 , 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.
9 . The system of claim 6 , wherein the diafiltration component comprises a flow cell.
10 . The system of claim 9 , wherein the product section comprises tubing positioned within the flow cell and the diafiltration membrane comprises the tubing material.
11 . The system of claim 1 , further comprising a cell extraction module for extracting cells used by the production module to produce the protein.
12 . The system of claim 11 , cell extraction module comprises a whole blood separator and a blood cell lysing module.
13 . A system for delivering a therapeutic protein to a patient, comprising:
a cell extraction module for extracting cells from blood obtained from the patient;
a reactor for therapeutic protein expression using the cells extracted from the patient's blood; and
a purification module for receiving the protein from the production module and for purifying the protein from reagents.
14 . The system of claim 13 , wherein the purification module comprises:
a chromatography component for receiving and purifying therapeutic protein output by the reactor; and
a diafiltration component for receiving purified protein from the membrane chromatography and for further purifying the purified protein.
15 . The system of claim 13 , 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.
16 . The system of claim 14 , 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.
17 . The system of claim 14 , wherein the diafiltration component comprises:
a first substrate;
a second substrate; and
a diafiltration membrane positioned between the first and second substrates.
18 . The system of claim 16 , 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.
19 . The system of claim 14 , wherein the chromatography component comprises a membrane chromatography component.
20 . The system of claim 14 , wherein the chromatography component comprises a column chromatography component.