Novilytic, LLC

Fred Regnier

JinHee Kim

Meena Narsimhan

Nathan Morris

Mary Bower

Paul Dreier

Jinhee Kim

A method is provided to simultaneously identify and quantify critical structure attributes (CSAs) in proteoforms or proteoform families that includes the steps of:

Molecular recogntion assays of critical structure attributes in proteoforms

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.

Proteoform specific process validation

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West Lafayette, IN, United States of America

Fred Regnier