Abstract: A system and method is provided for validating the manufacturing process for the production of complex biological compositions, and particularly for providing process validation information for evaluation by a federal regulatory agency. The system and method continuously and chronologically assess the concentration of proteoforms within the biological composition as it is being produced in a fermentor. Samples from the fermentor are analyzed in a pre-selected array of analysis columns, with data generated by the columns being accumulated and evaluated, and particularly compared with data from previous stages in the production process. A continuous process validation system includes top-down and bottom-up analysis sectors, each including a plurality of different analysis columns that can be selected by the controller for a particular biological composition and a particular production process.

Abstract: An adaptive surface for supporting an analyte to be examined, includes a support layer, a metal island layer, and an adhesive layer by which the metal island layer is attached to the support layer, the adhesive layer and metal island layer being interactive with an analyte containing solution to permit movement of at least some of the islands on the adhesive layer into increasingly close proximity during drying of the analyte solution.