#Canada #Calgary #Nanalysis #USP #Benchtop NMR

Nanalysis and USP Collaboration

In a significant advancement for the pharmaceutical industry, Nanalysis Scientific Corp. has partnered with the United States Pharmacopeia (USP) to co-publish a study that underscores the efficacy of benchtop Nuclear Magnetic Resonance (NMR) technology in quality control procedures for active pharmaceutical ingredients (APIs). The findings are anticipated to revolutionize quality assurance processes, enabling pharmaceutical companies to ensure product integrity more effectively.

The Future of Pharma Quality Control

Sean Krakiwsky, Founder and CEO of Nanalysis, expressed his optimism about the role of benchtop NMR in the pharmaceutical sector. “We envision benchtop NMR becoming essential in the multi-billion-dollar pharmaceutical quality control market in the near future,” he stated. The traditional NMR systems, while revered for their accuracy at the molecular level, have long been cumbersome due to size and operational demands. Nanalysis addresses this issue with its new benchtop models, which promise accuracy without the impracticalities of larger systems.

The CEO praised the company’s scientific and product teams for pushing the boundaries of technology within regulatory frameworks, reducing the specialized expertise required to operate such instruments. Automation features and strategic partnerships further enhance the adoption of this innovative technology.

A New Standard in Quality Testing

Acknowledging the historical significance of USP in pharmaceutical standards, Ben Shapiro, Digital Product Development Director at USP, mentioned the organization’s commitment to modernizing quality testing methodologies. The newly released USP-ID emphasizes advanced technologies, enabling more standardized and accessible NMR data for quality control. Shapiro noted, “The introduction of benchtop NMR spectroscopy improves accessibility to quality testing methods such as quantitative NMR (qNMR).”

Dr. Susanne D. Riegel, Nanalysis’ Vice President of Marketing and NMR Product Manager, highlighted the collaborative efforts with USP to refine existing methodologies and adapt quality assurance processes within the pharmaceutical sector. Notably, the benchtop NMR technology offers several advantages over traditional lab methods, such as significantly faster measurement times, a reduction in toxic solvent usage, simpler sample preparation, and the ability to operate without extensive calibration.

Advantages of Benchtop NMR

Some identified key benefits include:

• - Faster measurements: Quicker turnarounds for essential quality control processes.
• - Reduced solvent consumption: Enhancing sustainability within laboratories.
• - Ease of use: Minimal calibration needed means that more personnel can utilize the technology.
• - Non-destructive testing: Preserves sample integrity while increasing measurement reliability.

The transition to an automated analysis method, represented by USP-ID, potentially lowers barriers to entry, making it easier for pharmaceutical and biotech companies to integrate benchtop NMR into their quality control processes. As regulatory requirements evolve, the demand for effective and accessible quality control methods will only grow.

Expanding Horizons

As Nanalysis continues to innovate, it plans to foster relationships with several regulatory bodies, not just USP, but across international markets like Europe and Japan. The forecast for the pharmaceutical quality control sector, valued in billions, suggests a promising trajectory propelled by the adoption of reliable and efficient technologies.

Nanalysis has already made its mark with its portable Nuclear Magnetic Resonance (NMR) spectrometers, particularly the NMReady-60™, which was a breakthrough in its compactness and utility. With ongoing advancements leading up to the company’s impressive 100MHz device, the NMR landscape is poised for transformation.

Conclusion

Looking ahead, Nanalysis aims to continue developing and submitting novel benchtop NMR methods for acceptance by regulatory authorities, driving growth and improvement in quality assurance processes within the global pharmaceutical industry. As the landscape shifts towards more robust and automated testing methodologies, the partnership with USP signals an inspiring advancement in pharmaceutical safety and efficacy practices.

For those interested in an in-depth look at the USP publication regarding this groundbreaking study, more information can be accessed here.