Nirrin's Atlas product [Image: Nirrin Technologies]
Nirrin Technologies, a US company developing analytical tools for bioprocess analysis, announced in early September that it had been awarded a Small Business Innovation Research (SBIR) Direct Phase II Grant from the National Institutes of Health (NIH). The US$2 million in funding will go toward further development of Nirrin’s near-infrared (NIR) spectroscopy technique for rapid characterization of biomanufacturing processes.
Harnessing the near-infrared
Nirrin says in a press release that analytics workflows in biomanufacturing “require precise monitoring of product components at each step of the process, yet they suffer from a lack of data or slow data collection.” The firm’s solution to this data problem is to improve bioprocess analysis with its high-precision tunable laser spectroscopy (HPTLS) platform.
The HPLTS approach integrates NIR spectroscopy with a tunable laser source. A liquid sample is placed between two sapphire windows at a fixed path length, and NIR laser light is sent through the sample. As the laser is tuned, the amount of light transmitted changes based on the chemical composition of the sample.
Nirrin says HPTLS can tune 200 to 300 nm. The firm claims that makes the method “unique,” as this capability allows it to “capture all chemical information necessary” to analyze a sample. The company also says that the chemical bonds in the HPTLS wavelength range provide access to bioprocess analytes like sugars, amino acids and proteins, and surfactants.
In July, Nirrin launched its flagship Atlas product, a system powered by HPTLS. According to the company, it provides quantitative chemical data with 15 µl of sample in about a minute, and includes access to an analyte library. Nirrin says that Atlas enables the simultaneous analysis of excipients, proteins, surfactants and other components at the point of sampling to “address data-collection challenges for downstream processing in the pharmaceutical industry.”
Nirrin plans to apply the SBIR funds to ramp up development on upstream bioprocessing applications for bioreactor automation and control using Atlas.
NIH gives a shot in the arm
The NIH’s SBIR grant is part of its Small Business Programs, known as “America’s seed fund.” These programs provide support to early-stage small businesses to stimulate technological innovation while meeting US federal R&D needs, with the goal of ultimately increasing private-sector commercialization of innovations developed through federal R&D funding. The Direct Phase II grant awarded to Nirren provides about US$2 million with a project timeline of one to three years.
Nirrin plans to apply the SBIR funds to ramp up development on upstream bioprocessing applications for bioreactor automation and control using Atlas. The company says it will also expand its HPTLS-based product line to include real-time monitoring and control in-line and in situ for cell and gene therapy and other key application areas.
“The SBIR Direct Phase II Grant is a competitive award, and we’re honored the NIH committee recognizes the importance of our HPTLS technology platform to help eliminate critical data gaps throughout the bioprocess,” says Nirrin CEO Greg Crescenzi. “Our ultimate goal is to equip biomanufacturing teams with tools that enable them to both identify and immediately intervene on potential issues in advance, ensuring biopharmaceutical product consistency, safety, and compliance with regulatory standards.”