Modular process analytical technology testing apparatus

A mobile, modular apparatus for deploying process analytical technology in a pharmaceutical or biopharmaceutical manufacturing process, the apparatus comprising a mobile platform with a weighted base, a control cabinet and an instrument stack disposed within a housing comprising inlet and outlet ports,

• wherein the control cabinet comprises a human machine interface, a controller, and a data acquisition and analysis software layer and the instrument stack comprises two or more process analytical instruments and associated flow cells, a tubing assembly and valves;
• wherein each of the process analytical instruments is adapted to measure an indication of at least one product attribute from a process fluid flowing through its associated flow cell;
• wherein the inlet and outlet ports of the housing connect the flow cells via the tubing assembly in a recirculation loop to a flow path of at least one unit operation of the manufacturing process for in-line data acquisition and analysis;
• and
• wherein the controller and data acquisition and analysis software operate to (i) compare the indication of the at least one product attribute against a predetermined range for the attribute, (ii) determine whether the indication is within the range, and (iii) initiate a first action if the received indication is within the range or a second action if the indication is outside the range.