System and method for production of on-demand proteins in a portable unit for point of care delivery

1. A method of stimulating production of granulocytes in a patient undergoing cancer therapy, said method comprising administering a Granulocyte Colony Stimulating Factor (G-CSF) protein to the patient, wherein the G-CSF is synthesized on-demand in a bioprocessing system using cell-free protein expression, said bioprocessing system comprising:

a production module for producing non-purified G-CSF protein, and

a purification module for receiving the non-purified G-CSF protein from the production module and for purifying the G-CSF protein.

2. The method of claim 1 , wherein the G-CSF protein can be administered continuously or as a bolus to the patient.

3. The method of claim 1 , wherein the purification module comprises:

a chromatography component for receiving the non-purified G-CSF protein from the production module and for outputting purified G-CSF protein; and

a diafiltration component for receiving the purified G-CSF protein from the chromatography component and for outputting further purified G-CSF protein, wherein the diafiltration component comprises a product section for receiving the purified G-CSF protein from the chromatography component and a buffer section for receiving a buffer solution.

4. The method of claim 3 , wherein the buffer solution is free of dithiothreitol (DTT).

5. The method of claim 1 , wherein the production module comprises a reaction mixture comprising a nucleotide template for production of the G-CSF protein, monomers for the G-CSF protein to be synthesized, co-factors, enzymes and reagents that are necessary for the synthesis.

6. The method of claim 5 , wherein the enzymes and reagents that are necessary for the synthesis are ribosomes, tRNA, polymerases and transcriptional factors.

7. The method of claim 1 , wherein the production module comprises a bioreactor for cell-free G-CSF protein expression.

8. The method of claim 3 , wherein the diafiltration component further comprises: a first substrate; a second substrate; and a diafiltration membrane positioned between the first and second substrates.

9. The method of claim 8 , wherein the diafiltration component comprises a flow cell.

10. The method of claim 1 , wherein the production module comprises at least one sensor for monitoring at least one of conductivity, temperature, pH, oxygen and CO 2 .

11. The method of claim 1 , wherein the production module and purification module each comprise a heating and cooling element for controlling the temperature of solution inside the production module and purification module.

12. The method of claim 1 , wherein the bioprocessing system further comprises a fluid storage and dispensing module for storing solutions used by the production module for G-CSF protein expression, for storing waste product produced by the purification module, and for storing G-CSF protein output by the purification module.

13. The method of claim 1 , wherein the bioprocessing system further comprises a processor for controlling and/or monitoring at least one of the production module and the purification module.

14. The method of claim 1 , wherein a therapeutic dose and potency/activity of the G-CSF protein is determined by expression time in the production module.

15. The method of claim 1 , wherein the G-CSF protein is delivered directly to the patient.

16. The method of claim 1 , wherein a therapeutic dose and potency/activity of the G-CSF protein is determined by holding time in the production module.

17. The method of claim 1 , wherein potency/activity of the purified G-CSF protein is at least 55% or more of the initial activity for at least 3 days at temperature from above 0° C. to about 30° C.

18. The method of claim 1 , wherein the cancer therapy comprises drugs that cause low white blood cell counts in the patient.

19. A method of treating anemia in a patient in need thereof, said method comprising administering Erythropoetin (EPO) to the patient, wherein the EPO is synthesized on-demand in a bioprocessing system using cell-free protein expression, said bioprocessing system comprising:

a production module for producing non-purified EPO protein, and

a purification module for receiving the non-purified EPO protein from the production module and for purifying the EPO protein.

20. A method of treating a clot or achieving thrombolysis in a patient in need thereof, said method comprising administering Streptokinase to the patient, wherein the Streptokinase is synthesized on-demand in a bioprocessing system using cell-free protein expression, said bioprocessing system comprising:

a production module for producing non-purified Streptokinase protein, and

a purification module for receiving the non-purified Streptokinase protein from the production module and for purifying the Streptokinase protein.