A tunable laser scanning system for rapid analysis of biopharmaceutical formulations

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. 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. An foreseen challenge with the current Phase II project is the need for validated standards to be used for customer validation as well as post-installation quality assessment. Aim 1 has been largely completed, optimizing system design, however, Aim 2 will significantly benefit from the supplement proposed here. Often reagents generated by customers have significant errors from batch to batch, and so highly controlled standards must be generated. The company has previously relied on NIST-validated reagents; however many customers are using custom reagents that are not available in NIST-qualified aliquots. Supplemental funding is therefore requested to acquire quantification instrumentation for both protein (Repligen SoloVPE System) and small molecules (Agilent HPLC). These will be used to test standards, as well as produce sets of qualified dilution series for multiple reagents for aim 3 external validation at customer sites.