Nirrin Technologies launched the Atlas™ system for at-line excipient and product titer quantitation in downstream bioprocessing applications.

The existing analytical workflow for biomanufacturing is full of blind spots and bottlenecks that contribute to increased time to market and manufacturing costs for critical drugs, according to a number of experts. 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. 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.

Atlas, powered by tunable laser spectroscopy™ (HPTLS) technology, reportedly enables simultaneous analysis of buffer excipients, such as surfactants and amino acids, and high concentration proteins, such as monoclonal antibodies, peptides, and vaccines in one minute throughout the bioprocess.

Critical data

“This simple to use system delivers critical data with the accuracy and sensitivity of HPLC, bringing the power of the core lab right to the point of sampling,” said Greg Crescenzi, CEO of Nirrin. “Atlas quickly reveals blind spots and overlooked issues that can become bigger problems throughout the bioprocess, giving scientists more predictive and proactive control over their process like never before. Armed with the needed insights to make confident decisions in-hand, they can eliminate unnecessary wait time and be more selective on which samples are sent to the core lab for further analysis.”

Atlas system
Atlas™ system [Nirrin Technologies]

Early adopter studies conducted by ten top global pharmaceutical companies demonstrated the potential of Atlas’ HPTLS as a reliable method that overcomes the limitations of traditional analysis techniques and opens new possibilities for studying and optimizing protein formulations, continued Crescenzi.

Nirrin’s HPTLS technology unlocks the power of near-infrared (NIR) spectroscopy with a tunable laser source to provide unique, quantitative signatures for excipients, proteins, surfactants and more, noted. Bryan Hassell, PhD, Nirrin founder and CTO.

“Bioprocess groups shouldn’t have to wait for retrospective data from the core lab, they need data they can trust, now,” said Hassell. “Atlas debottlenecks current analytical workflows with a system anyone can use and get accurate, reliable data in a minute or less. There are no other at-line technologies that can provide the data-driven insights biopharma needs to react quickly and effectively.”

“With Atlas, bioprocess groups now have a single tool that can be used to benchmark their unique processes in both development and manufacturing, and deliver cost-effective, actionable answers on-demand,” added Crescenzi. “Atlas is Nirrin’s first step towards what the biopharmaceutical industry has been waiting on for a long time—real-time monitoring and integrated control of their bioprocess. Our current development focus is on continuous manufacturing, and early collaborators are already having great success with Atlas for analysis of their critical process parameters.”

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