Just-in-time bioprocess plant system
An integrated platform system controlled with hardware and software for just-in-time, local manufacturing is disclosed. System hardware may include a fermentation system, a cross-flow system, a disposable formulation system, a robotic fill-finish system, and a quality control test and release system.
1. A modular system for just-in-time manufacturing of a plurality of biologicals, comprising:
a supervisory control system, wherein the supervisory control system executes software adapted to manufacture a desired biological;
a batch manufacturing records database in communication with the supervisory control system, wherein the batch manufacturing records database stores a plurality of instructions for manufacturing different biologicals;
an automatic clean in place and sterilize in place system adapted to maintain the sterility of the system; and
a plurality of different of plug-in-play manufacturing modules, wherein at least one of the plurality of different plug-in-play manufacturing modules is coupled to the system based on the desired biological;
wherein the supervisory control system obtains instructions for manufacturing the desired biological from the batch manufacturing records database, determines what plug-in-play manufacturing modules are coupled to the system, and controls flow of matter through each of the plug-in-play manufacturing modules coupled to the system based on the instructions for manufacturing the desired biological.
2. The system of claim 1 , wherein the biologicals are one of cells, viruses, bacteria, bacterial products, recombinant products, and vectored products.
3. The system of claim 2 , wherein the vaccines are one of polysaccharide vaccines, inactivated whole-cell pertussis vaccines, cell based inactivated influenza vaccines, inactivated rabies vaccines, hepatitis vaccines, and yellow fever live-attenuated vaccines.
4. The system of claim 1 , wherein the plug-in-play manufacturing modules are chosen from the group comprising scale-up fermentation modules, centrifugation modules, chromatography modules, homogenization modules, enzyme reaction modules, acid digestion modules, inactivation modules, alkaline digestion modules, diafiltration modules, cross flow filtration modules, ultrafiltration modules, microfiltration modules, and inoculation modules.
5. The system of claim 4 , wherein the inoculation modules include at least one of isolated seed vials, cold-storage, a robotic arm, a seed fermenter, a one-way sterile material transfer system, a full scale fermenter, and an isolation system.
6. The system of claim 1 , wherein the system is mobile and adapted to be setup on site.
7. The system of claim 1 , wherein the biological is manufactured in less than 5 weeks.
8. The system of claim 1 , wherein the system is autonomous.
9. The system of claim 1 , wherein the system is a closed system.
10. The system of claim 1 , wherein the system is scalable to increase output.
11. The system of claim 1 , further comprising software adapted to record manufacturing records.
12. The system of claim 1 , further comprising an alert system adapted to indicate breakdowns in the process and transmit instructions to correct the breakdowns.
13. The system of claim 1 , wherein the supervisory control system validates the produced biologicals.
14. The system of claim 13 , wherein the validation is tamper-proof.
15. The system of claim 1 , wherein the system manufacturers biologicals continuously.
16. The system of claim 13 , wherein the validations is a quality control validation.