Nanalysis and The United States Pharmacopeia (USP) Co-Publish Study Demonstrating Efficacy of Benchtop NMR for Quality Control

CALGARY, AB, Dec. 11, 2024 /CNW/ - Nanalysis Scientific Corp. ("the Company", TSXV: NSCI, OTCQX: NSCIF, FRA: 1N1), a leader in portable NMR instruments and MRI technology for industrial and research applications announces results of study by the United States Pharmacopeia (USP) concluding that benchtop NMR is efficacious for quality control of active pharmaceutical ingredients (API).

"In the not-too-distant future, we expect that benchtop NMR will become an important tool in the multi-billion-dollar market for quality control in the pharmaceutical industry," said Sean Krakiwsky, Founder and CEO of Nanalysis.  "NMR has long been a gold standard for testing at a molecular level. Due to the size and requirements of larger legacy NMR instruments, they were not practical for use in many environments, like larger scale production/manufacturing facilities.  Our novel benchtop NMR products provide high quality data with reliability and convenience that, due to their form factor, work well in these applications."

"Our scientific and product teams are doing great work establishing regulatory tailwinds, reducing expertise required to generate and process data, increasing automation and establishing partnerships in this area," continued Mr. Krakiwsky.   

Ben Shapiro, Digital Product Development Director at USP says, "USP has a long history of developing quality standards for prescription drugs, over-the-counter drugs, and veterinary medicines to ensure the highest level of quality. The release of USP-ID reflects our commitment to leveraging innovative technologies to automate and normalize NMR data, supporting modernization and digitalization in pharmaceutical quality control. Advances such as benchtop nuclear magnetic resonance (NMR) spectroscopy help make testing methods, like qNMR, more accessible and scalable." 

Dr. Susanne D. Riegel, Nanalysis VP Marketing & NMR Product Manager says,  "We have been working closely with USP as they look to modernize their monographs and methodology throughout QA in the pharmaceutical industry. While, not as established as other techniques, such as liquid chromatography, benchtop NMR can have the following benefits:

• faster measurements
• reduction in harmful and expensive solvent consumption
• Simple sample preparation
• can be run without calibration
• Non-destructive, and non-targeted, increasing reliability of measurements

"The use of an automated analysis method, like USP-ID, reduces the barrier to entry for benchtop NMR into pharma/biotech QC, and helps establish the value proposition to do so. The market for pharmaceutical quality control is multi-billion per year globally, and we expect data regulatory requirements to tighten, driven by demand for more consistent safer pharmaceuticals. Now that NMR has become miniaturized, it will become a critical technique in this market, due to its clear advantages of accessibility, affordability and automatability.

"Our company continues to provide innovative hardware and software solutions.  By establishing great working relationships with organizations, such as USP, over the next several years, we expect to submit many benchtop NMR methods to USP for their acceptance, which will in turn be a growth driver for QA/QC in the pharmaceutical industry globally as we work also with other pharmacopeia jurisdictions, such as Europe and Japan."

Click on this link for full access to the USP publication: https://go.usp.org/WhitePaperBenchtopNMR

About Nanalysis Scientific Corp. (TSXV: NSCI, OTCQX: NSCIF, FRA:1N1)

Nanalysis Scientific Corp. in operates two primary business segments: Scientific Equipment and Security Services. Within its Scientific Equipment business is what the Company terms "MRI and NMR for industry". The Company develops and manufactures portable Nuclear Magnetic Resonance (NMR) spectrometers or analyzers for laboratory and industrial markets. The NMReady-60™ was the first full-feature portable NMR spectrometer in a single compact enclosure requiring no liquid helium or any other cryogens. The Company has followed-up that initial offering with new products and continues to have a strong innovation pipeline. In 2020, the Company announced the launch of its 100MHz device, the most powerful and most advanced commercial compact NMR device ever brought to market. 

The Company's devices are used in many industries (oil and gas, chemical, mining, pharma, biotech, flavor and fragrances, agrochemicals, law enforcement, and more) as well as numerous government and university research labs around the world. The Company is working to expand into new global market opportunities independently and with partners.  With its partners, the Company provides scientific equipment sales and maintenance services globally. 

In 2022 the Company was awarded a five-year, $160 million contract to provide maintenance services for passenger screening equipment in Canadian airports.  This has resulted in expansion of the Company's Security Services business.  The Company is providing airport security equipment maintenance services in each province and territory of Canada.  In addition, the Company provides commercial security equipment installation and maintenance services to a variety of customers in North America. 

About USP

USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality resources and standards for medicines, dietary supplements and food ingredients. This includes actively collaborating with academic research centers, industry, and regulators to help with the adoption and implementation of advanced manufacturing technologies. Through our resources, standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and foods for billions of people worldwide. For more information, visit: www.usp.org.

The usage of Nanalysis NMR equipment with USP-ID in the study does not imply approval, endorsement, or certification by USP of Nanalysis products, nor does it imply that Nanalysis products are necessarily the best available product for the purpose or that any other brand or product was judged to be unsatisfactory or inadequate. As a standard setting organization, USP avoids conflicts of interest that interfere or appear to interfere with its impartiality and objectivity.

Notice regarding Forward Looking Statements and Legal Disclaimer

This news release contains certain "forward-looking statements" within the meaning of such statements under applicable securities law. Forward-looking statements are frequently characterized by words such as "anticipates", "plan", "continue", "expect", "project", "intend", "believe", "anticipate", "estimate", "may", "will", "potential", "proposed", "positioned" and other similar words, or statements that certain events or conditions "may" or "will" occur. These statements are only predictions. Various assumptions were used in drawing the conclusions or making the projections contained in the forward-looking statements throughout this news release. Forward-looking statements are based on the opinions and estimates of management at the date the statements are made and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. The Company is under no obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by applicable law.

Neither TSX Venture Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release.

SOURCE Nanalysis Scientific Corp.

Contacts: Matthew Selinger, Firm IR Group, 415-572-8152, [email protected]