Project Summary The goal of this Direct to Phase II SBIR proposal is continue development of Nirrin’s proprietary tunable laser spectrometry system in preparation for commercialization. Biomanufacturing at commercial scale requires precise monitoring of product components, including active pharmaceutical ingredients (APIs) such as proteins, peptides, and nucleic acids, but also supporting excipients which are essential for overall safety and efficacy. Process errors can lead to incorrect concentrations of APIs and excipients leading to extremely costly process revisions and millions of dollars of waste in the form of adulterated product. Ensuring that biomanufacturing processes remain consistent and compliant with FDA mandates regarding product composition is of urgent importance to the biopharmaceutical industry. Methods which allow continuous real-time monitoring of product components and support reliable, accurate and precise measurements are therefore of extremely high value. Currently manufacturers rely on detailed process documentation to ensure product integrity and protocol adherence, as well as end-point analysis using HPLC, mass spectrometry, or Raman spectrometry, among other costly, time-consuming methods. None of these technologies are compatible with rapid, real-time analysis, supporting only end-point analysis after full commercial-scale batches of product are generated. In fact, many analytical methods require samples to be sent to contractors with data coming back after multiple days or even weeks. Nirrin Technologies, Inc. has developed the NXT platform, a rapid and sensitive instrument for the simultaneous analysis of biopharmaceutical APIs and excipients from a single sample with zero up-front sample preparation. The system relies on tunable laser spectrometry, scanning samples across multiple wavelengths and compiling absorbance spectra unique to the given analyte. Absorbance spectra have been developed and validated for dozens of biopharmaceutical API’s and excipients and can be rapidly analyzed via Nirrin’s straightforward software user interface. The NXT workflow has been evaluated by multiple biopharmaceutical companies and satisfies many of the key product requirements which competing technologies do not. During this Direct to Phase II program, we will optimize the design of the NXT system and fabricate 6 beta systems prior to internal quality testing. Testing batteries will also be undertaken to satisfy the requirements for global commercialization, including UL and CE marking. Systems will then be prepared for external validation testing with at least three major biopharmaceutical companies. These activities are expected to dramatically accelerate the commercialization of Nirrin’s tunable laser spectroscopy products while reducing manufacturing errors prior to the launch of new biopharmaceuticals.