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05 Sep 2024
Massachusetts startup working on high-precision analytical technique based around a tunable laser.
The US National Institutes of Health (NIH) has selected Nirrin Technologies for a $2 million grant to further develop its optical spectroscopy technique for rapid characterization of complex biomanufacturing processes.
The Billerica, Massachusetts, company, which also raised nearly $5 million in equity funding earlier this year, has devised a near-infrared (NIR) approach based around a tunable laser that it says will provide a major improvement on existing methods.
“Analytical 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,” explains the firm.
“Technologies on the market today aren’t compatible with the rapid, real-time analysis that would immediately reveal any blind spots or potential issues that can lead to significant development delays later in the bioprocess.”
‘Atlas’ launched
Nirrin recently launched its flagship “Atlas” product to address the issue, describing it as “an elegant, quantitative method for the analysis of bioprocess components with wide dynamic range, accuracy, and precision”.
Available since early July, it enables simultaneous analysis of buffer excipients, such as surfactants and amino acids, and high-concentration proteins, such as monoclonal antibodies, peptides and vaccines, which can all be assessed within 60 seconds throughout the bioprocess.
The Phase II small business innovation research (SBIR) grant from NIH will be aimed at ramping up development on upstream bioprocessing applications for bioreactor automation and control using Atlas.
Nirrin 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.
CEO Greg Crescenzi commented: “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.”
‘De-bottlenecking’ analytical workflows
Founded by current CTO Bryan Hassell in 2018, Nirrin contrasts the capability of is laser spectroscopy platform with the existing analytical workflow for biomanufacturing, which it says is full of “blind spots and bottlenecks” that delay commercialization of new pharmaceuticals and increase manufacturing costs.
“Therapeutic development is an iterative and complicated process requiring analysis at each step of the process and suffers from either no data or slow data collection,” states the firm.
“If samples are taken, they are typically sent to a core analytical lab for HPLC analysis, and drug development timelines are often delayed for 4-6 weeks waiting on its retrospective data.”
Early adopter studies conducted by ten top global pharmaceutical companies are said to have demonstrated the potential of Atlas’s high-precision tunable laser spectroscopy (HPTLS) approach as a reliable method that overcomes the limitations of traditional analysis techniques.
“Atlas de-bottlenecks current analytical workflows with a system anyone can use and get accurate, reliable data in a minute or less,” said Hassell when Nirrin released the product.
“There aren’t any other at-line technologies that can provide the data-driven insights biopharma needs to react quickly and effectively.”
Nirrin Technologies corporate video explainer: "Making medicines easier to make"
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