Manufacturing system for biopharmaceutical products

1. A method for quality assured manufacturing of at least two biopharmaceutical products in a manufacturing system, the manufacturing system comprising:

a macro structure,

at least two micro nodes and a network spine interconnecting the macro structure with each micro node, the macro structure comprising a warehouse facility and a hydration facility, and the at least two micro nodes representing inter-operationally discrete biopharmaceutical manufacturing facilities,

wherein the macro structure and each micro node respectively each comprise a communication interface to the network spine,

wherein the communication interface comprises a data interface arranged to receive culture media and/or buffer orders from at least one of the micro nodes and to return a materials delivery to the micro node in response to the received order, wherein verification of the materials delivery is performed prior to enabling delivery over a materials delivery interface,

wherein a control facility in the macro structure is configured to control interoperability of the macro structure and the micro nodes by means of the network spine, the method comprising:

receiving, in the control facility of the macro structure, a request for customized culture media and/or buffer;

customizing culture media and/or buffer in the hydration facility in response to an order from the control facility; and

delivering the customized culture media and/or buffer to the requesting micro node in response to an order from the control facility.

2. The method of claim 1 , further comprising:

receiving one or more at finalized biopharmaceutical products from each respective micro node in a warehouse facility of the macro structure.

3. A method for quality assured manufacturing of at least two biopharmaceutical products in a manufacturing system, the manufacturing system comprising:

a macro structure,

at least two micro nodes and a network spine interconnecting the macro structure with each micro node, the macro structure comprising a warehouse facility and a hydration facility, and the at least two micro nodes representing inter-operationally discrete biopharmaceutical manufacturing facilities,

wherein the macro structure and each micro node respectively each comprise a communication interface to the network spine,

wherein the communication interface comprises a data interface arranged to receive culture media and/or buffer orders from at least one of the micro nodes and to return a materials delivery to the micro node in response to the received order, wherein verification of the materials delivery is performed prior to enabling delivery over a materials delivery interface,

wherein a control facility in the macro structure is configured to control interoperability of the macro structure and the micro nodes by means of the network spine, the method comprising:

obtaining, in the respective micro nodes, supply materials comprising customized culture media and/or buffer from the macro structure by means of the network spine; and

processing, in each micro node, the supply materials to produce respective biopharmaceutical products.

4. The method of claim 3 , further comprising:

transferring, from each respective micro node, the biopharmaceutical product, to the macro structure by means of the network spine.

5. A manufacturing system for quality assured manufacturing of at least two biopharmaceutical products, the manufacturing system comprising:

a warehouse facility,

a hydration facility, and

at least two biopharmaceutical manufacturing facilities,

wherein

the warehouse facility and hydration facility are comprised in the macro structure,

each biopharmaceutical manufacturing facility is comprised in a respective micro node, and

a control facility, having a hardware processor, in the macro structure is configured to control interoperability of the macro structure and the micro nodes by means of a network spine interconnecting the macro structure with each micro node,

wherein the macro structure and each micro node respectively each comprise a communication interface to the network spine,

wherein the communication interface comprises a data interface arranged to receive culture media and/or buffer orders from at least one of the micro nodes and to return a materials delivery to the micro node in response to the received order, wherein verification of the materials delivery is performed prior to enabling delivery over a materials delivery interface.

6. The manufacturing system of claim 5 , wherein each micro node is supported by the macro structure by means of the network spine and is self-sufficient and independent of the other micro nodes.

7. The manufacturing system of claim 6 , wherein each micro node is inter-operationally discrete from the other micro nodes.

8. The manufacturing system of claim 5 , wherein each micro node comprises a stand-alone control unit.

9. The manufacturing system of claim 5 , wherein the communication interface comprises the materials delivery interface.

10. The manufacturing system of claim 9 , wherein the materials delivery interface is a materials air lock.

11. The manufacturing system of claim 9 , further comprising automated guided vehicles arranged for materials delivery between the macro structure and the micro nodes.

12. The manufacturing system of claim 9 , wherein the materials delivery comprise supply material delivered to a designated micro node in single-use equipment, the supply material comprising customized culture media and/or buffer.

13. The manufacturing system of claim 9 , wherein the micro nodes are arranged to receive materials delivery of single-use product contact components.

14. The manufacturing system of claim 5 , wherein the network spine is preconfigured for retrofit connection of one or more further micro nodes.

15. The manufacturing system of claim 5 , wherein each micro node comprises a further communication interface controlled by the stand-alone control unit, wherein the further communications interface is arranged to control communication between the micro node and a public area.

16. A computer program product comprising:

at least one non-transitory computer readable storage medium having computer-executable program code instructions store therein, the computer-executable program code instructions comprising program code instructions configured to, when executed in a control facility of a macro structure:

receive, from a micro node, a request for supply material, wherein the supply material comprises customized culture media; and

control, in a hydration facility of the macro structure, preparation of the customized culture media,

wherein the macro structure and the micro node respectively each comprise a communication interface to a network spine,

wherein the communication interface comprises a data interface arranged to receive culture media and/or buffer orders from the micro node and to return a materials delivery to the micro node in response to the received order, wherein verification of the materials delivery is performed prior to enabling delivery over a materials delivery interface.