Systems and methods for bioprocess analysis
View Patent ↗Disclosed herein are systems, methods, and devices for monitoring and controlling bioprocess parameters. The systems and methods enable automated operation with real-time analysis of process conditions and analyte or biologic production.
1. A system for determining real-time analyte concentration measurements from fermentation liquid inside a growth vessel, comprising: a growth vessel comprising a fermentation liquid; a sampling system; a filtration system comprising a filter rotating at 3600 RPM; a cartridge with a stationary phase; an analyte detection system; a fraction collector; and a microprocessor, wherein said analyte concentration is less than 10 ug/mL.
2. The system of claim 1 , further comprising a sterile prefilled solvent reservoir.
3. The system of claim 1 , further comprising a pumping system.
4. The system of claim 1 , further comprising a multiport valve.
5. The system of claim 1 , further comprising prefilled solvent reservoirs.
6. The system of claim 1 , further comprising an optical detector.
7. The system of claim 1 , wherein said sampling system comprises a multichannel pump.
8. The system of claim 1 , wherein said analyte comprises a biologic.
9. The system of claim 1 , wherein said analyte comprises a drug.
10. The system of claim 1 , wherein said analyte comprises an antibody.
11. The system of claim 1 , wherein said analyte comprises a peptide.
12. A method for determining real-time analyte concentration measurements from fermentation liquid inside a growth vessel, comprising:
providing the system for determining real-time analyte concentration measurements of claim 1 ;
producing an analyte in the growth vessel comprising the fermentation media;
sampling and filtering the analyte in the sampling system and the filtration system, respectively;
loading the analyte onto the cartridge with the stationary phase; and
determining the concentration of analyte with the analyte detection system.
13. The method of claim 12 , wherein a solution of known concentration is injected into the sampling system to calibrate or check calibration of said sampling system.
14. The method of claim 12 , further comprising measuring data values for parameters including pH, dissolved O 2 , temperature, amino acid concentration and amino acid metabolite concentration; transmitting the measured data values to a processor, wherein corrective action is automatically taken by the system if a test value is not inside a desired range to ensure the parameters for optimal production are kept within the desired range.
15. The method of claim 12 , further comprising transmitting the data to a server.
16. The method of claim 12 , wherein the stationary phase is an affinity chromatography stationary phase comprising a protein.
17. The method of claim 16 wherein the protein comprises an antibody.
18. The method of claim 16 wherein the protein comprises an antigen.