Method and system for manufacturing of biopharmaceutical products

A method for expanding production volume capability of a manufacturing system for quality assured manufacturing of biopharmaceutical products associated with a biosafety level classification, the manufacturing system comprising a first multi-product suite and a control facility configured to control a unidirectional flow in a circulation system of the first multi-product suite;

• wherein the circulation system comprises separated supply and return systems, the supply system comprising an inlet, the return system comprising an outlet that is paired with the inlet and provided at a spatially predetermined position from the inlet, and the inlet/outlet pair comprises a seal, the method comprising
• arranging a second multi-product suite in a position adjacent to the first multi-product suite so that a spatially predetermined position of an inlet/outlet pair of the second multi-product suite is arranged to mirror the spatially predetermined position of an inlet/outlet pair of the first multi-product suite;
• interconnecting the inlet/outlet pair of the first multi-product suite with the inlet/outlet pair of the second multi-product suite;
• and
• breaking the seal of each inlet/outlet pair, and
• wherein the first multi-product suite is inter-operationally discrete from the second multi-product suite.

A method for decreasing production volume capability of a manufacturing system for quality assured manufacturing of biopharmaceutical products associated with a biosafety level classification, the manufacturing system comprising two or more multi-product suites and a control facility configured to control a unidirectional flow in a circulation system of the two or more multi-product suites;

• wherein the circulation system is configured to interconnect the two or more multi-product suites and wherein the circulation system comprises separated supply and return systems and wherein each multi-product suite of the two or more multi-product suites comprises at least one inlet to the supply system and at least one outlet from the return system, wherein the outlet is paired with the inlet and provided at a spatially predetermined position from the inlet, and the two or more multi-product suites are arranged in adjacent positions having the an inlet/outlet pair of a first multi-product suite of the two or more multi-product suites interconnected with an inlet/outlet pair of a second multi-product suite of the two or more multi-product suites;
• the method comprising:
• disconnecting the first and second multi-product suites by sealing the inlet/outlet pair of the first multi-product suite and/or the second multi-product suite;
• and
• adapting the control facility to control a unidirectional flow in the first multi-product suite, and
• wherein each multi-product suite of the two or more multi-product suites is inter-operationally discrete from the other multi-product suites of the two or more multi-product suites.