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: The present invention comprises methods for determining the presence, amount, or concentration of analytes of interest including Vitamin D and other secosteroids from biological samples, through derivatization, with improved speed and ease of analysis and improved sensitivity to mass spectrometry. In a preferred embodiment, the present invention comprises methods for determining the presence, amount, or concentration of analytes of interest, including Vitamin D and other secosteroids from whole human blood, through derivatization, and using a plasma collection device to facilitate collection, separation, and preparation of the sample for derivatization and analysis.