Nanalysis and The United States Pharmacopeia (USP) Co-Publish Study Demonstrating Efficacy of Benchtop NMR for Quality Control
Nanalysis Scientific Corp (TSXV: NSCI, OTCQX: NSCIF) and the United States Pharmacopeia (USP) have published a study confirming the effectiveness of benchtop NMR for quality control of active pharmaceutical ingredients. The study highlights benchtop NMR's potential in the multi-billion-dollar pharmaceutical quality control market.
The technology offers several advantages including faster measurements, reduced solvent consumption, simple sample preparation, calibration-free operation, and non-destructive testing. USP's automated analysis method, USP-ID, reduces barriers to entry for benchtop NMR in pharma/biotech QC applications.
The company plans to submit multiple benchtop NMR methods to USP for acceptance, targeting expansion into global pharmacopeia jurisdictions including Europe and Japan.
Nanalysis Scientific Corp (TSXV: NSCI, OTCQX: NSCIF) e la United States Pharmacopeia (USP) hanno pubblicato uno studio che conferma l'efficacia dell'NMR da banco per il controllo qualità degli ingredienti farmaceutici attivi. Lo studio mette in evidenza il potenziale dell'NMR da banco nel mercato del controllo qualità farmaceutico, che vale miliardi di dollari.
La tecnologia offre diversi vantaggi, tra cui misurazioni più rapide, ridotto consumo di solventi, preparazione semplice dei campioni, operazione senza bisogno di calibrazione e test non distruttivi. Il metodo di analisi automatizzato dell'USP, USP-ID, riduce le barriere all'ingresso per l'NMR da banco nelle applicazioni di QC farmaceutico/biotech.
La società prevede di presentare diversi metodi di NMR da banco all'USP per l'accettazione, puntando all'espansione nelle giurisdizioni delle farmacopee globali, inclusi Europa e Giappone.
Nanalysis Scientific Corp (TSXV: NSCI, OTCQX: NSCIF) y la United States Pharmacopeia (USP) han publicado un estudio que confirma la eficacia de la RMN de banco para el control de calidad de los ingredientes farmacéuticos activos. El estudio destaca el potencial de la RMN de banco en el mercado de control de calidad farmacéutico, que vale miles de millones de dólares.
La tecnología ofrece varias ventajas, incluyendo mediciones más rápidas, consumo reducido de disolventes, preparación simple de muestras, operación sin calibración y pruebas no destructivas. El método de análisis automatizado de la USP, USP-ID, reduce las barreras de entrada para la RMN de banco en aplicaciones de control de calidad en la industria farmacéutica/biotecnológica.
La empresa planea presentar múltiples métodos de RMN de banco a la USP para su aceptación, con el objetivo de expandirse a las jurisdicciones de farmacopeas globales, incluyendo Europa y Japón.
Nanalysis Scientific Corp (TSXV: NSCI, OTCQX: NSCIF)와 미국 약전(USP)은 활성 제약 성분의 품질 관리를 위한 벤치탑 NMR의 효과를 확인하는 연구를 발표했습니다. 이 연구는 벤치탑 NMR의 다중 수십억 달러 규모의 제약 품질 관리 시장에서의 잠재력을 강조합니다.
이 기술은 더 빠른 측정, 용매 소비 감소, 간단한 샘플 준비, 보정 없는 작동, 비파괴 검사 등 여러 가지 장점을 제공합니다. USP의 자동 분석 방법인 USP-ID는 제약/생명공학 QC 애플리케이션에서 벤치탑 NMR의 진입 장벽을 낮춥니다.
회사는 USP에 여러 벤치탑 NMR 방법을 제출하여 수용을 목표로 하며, 유럽과 일본을 포함한 글로벌 약전 관할권으로의 확장을 계획하고 있습니다.
Nanalysis Scientific Corp (TSXV: NSCI, OTCQX: NSCIF) et la United States Pharmacopeia (USP) ont publié une étude confirmant l'efficacité de la RMN de paillasse pour le contrôle qualité des principes actifs pharmaceutiques. L'étude met en avant le potentiel de la RMN de paillasse sur le marché du contrôle qualité pharmaceutique, qui pèse plusieurs milliards de dollars.
La technologie offre plusieurs avantages, notamment des mesures plus rapides, une consommation réduite de solvants, une préparation simple des échantillons, un fonctionnement sans calibration et des tests non destructifs. La méthode d'analyse automatique de l'USP, USP-ID, réduit les barrières à l'entrée pour la RMN de paillasse dans les applications de CQ pharma/biotech.
L'entreprise prévoit de soumettre plusieurs méthodes de RMN de paillasse à l'USP pour acceptation, visant une expansion dans les juridictions des pharmacopées mondiales, y compris en Europe et au Japon.
Nanalysis Scientific Corp (TSXV: NSCI, OTCQX: NSCIF) und die United States Pharmacopeia (USP) haben eine Studie veröffentlicht, die die Wirksamkeit von Tisch-NMR für die Qualitätskontrolle aktiver pharmazeutischer Inhaltsstoffe bestätigt. Die Studie hebt das Potenzial von Tisch-NMR auf dem mehrmilliardenschweren Markt für pharmazeutische Qualitätskontrolle hervor.
Die Technologie bietet mehrere Vorteile, darunter schnellere Messungen, reduzierter Lösungsmittelverbrauch, einfache Probenvorbereitung, kalibrierungsfreier Betrieb und zerstörungsfreie Tests. Die automatisierte Analysenmethode der USP, USP-ID, senkt die Eintrittsbarrieren für Tisch-NMR-Anwendungen in der pharmazeutischen/biotechnologischen QC.
Das Unternehmen plant, mehrere Tisch-NMR-Methoden bei der USP zur Akzeptanz einzureichen, um eine Expansion in globale Pharmakopöe-Jurisdiktionen, einschließlich Europa und Japan, anzustreben.
- Validation from USP establishes credibility in pharmaceutical quality control market
- Technology advantages include faster testing, reduced costs, and simplified operations
- Access to multi-billion-dollar pharmaceutical quality control market
- Automated analysis method reduces barrier to entry in pharma/biotech QC
- Technology not yet as established as competing methods like liquid chromatography
- Market penetration still in early stages
"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
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,
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.
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SOURCE Nanalysis Scientific Corp.
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