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

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

Nanalysis與美國藥典(USP)共同發佈研究,展示了臺式核磁共振用於質量控制的有效性。
PR Newswire ·  12/11 08:30

CALGARY, AB, Dec. 11, 2024 /PRNewswire/ - 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).

卡爾加里,阿爾伯塔省,2024年12月11日 /PRNewswire/ - Nanalysis Scientific Corp.("公司",TSXV:NSCI,OTCQX:NSCIF,FRA:1N1),在工業和研究應用領域的便攜式核磁共振儀器和MRI技術的領導者,宣佈美國藥典(USP)的一項研究結果,得出結論,臺式NMR對於活性藥物成分(API)的質量控制是有效的。

"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."

"在不久的將來,我們預計臺式NMR將成爲價值數十億美元的藥品質量控制市場中的一個重要工具," Nanalysis創始人兼首席執行官Sean Krakiwsky說。"NMR長期以來一直是分子水平測試的黃金標準。由於大型遺留NMR儀器的尺寸和要求,它們在許多環境中並不實用,例如大型生產/製造設施。我們的新型臺式NMR產品提供高質量的數據,具有可靠性和便利性,由於其形態因素,適合這些應用。"

"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.

"我們的科學和產品團隊在建立監管助力、降低生成和處理數據所需的專業知識、提高自動化以及在這一領域建立合作伙伴關係方面做得很好,"Krakiwsky先生繼續說。

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."

USP的數字產品開發董事Ben Shapiro表示,"USP在開發處方藥、非處方藥和獸藥的質量標準方面有着悠久的歷史,以確保最高水平的質量。USP-ID的發佈體現了我們利用創新技術自動化和規範化NMR數據的承諾,支持藥品質量控制的現代化和數字化。像臺式核磁共振(NMR)光譜這樣的進步幫助使得測試方法,例如qNMR,變得更易獲取和可擴展。"

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:

Nanalysis市場副總裁兼NMR產品經理Dr. Susanne D. Riegel表示,"我們一直在與USP密切合作,因爲他們希望在藥品行業的質量保證中現代化他們的專著和方法。儘管不像液相色譜等其他技術那麼成熟,臺式NMR可以帶來以下好處:"

  • 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
  • 更快的測量
  • 減少有害和昂貴溶劑的消耗
  • 簡單的樣品準備
  • 可以在無需校準的情況下進行
  • 非破壞性和非特定性,提高測量的可靠性

"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.

"使用自動化分析方法,如USP-ID,降低了臺式NMR進入藥品/生物科技質量控制的門檻,並幫助建立這樣做的價值主張。藥品質量控制市場在全球每年達數十億,我們預計數據監管要求將趨緊,因爲對更一致和安全藥品的需求正在增加。由於NMR已經變得小型化,它將成爲這個市場的一個關鍵技術,因爲它在可接觸性、可負擔性和自動化方面具有明顯的優勢。"

"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."

"我們公司繼續提供創新的硬件和軟件解決方案。通過與USP等組織建立良好的合作關係,在未來幾年內,我們預計會向USP提交許多臺式NMR方法以獲得他們的認可,這將反過來驅動全球藥品行業的QA/QC增長,同時我們還與其他藥典管轄區合作,如歐洲和日本。"

Click on this link for full access to the USP publication:

點擊此鏈接以獲取USP出版物的完整訪問權限:

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

關於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.

Nanalysis Scientific Corp. 主要運營兩個業務部門:科學設備和安防服務。在其科學設備業務內,公司稱之爲「行業用MRI和NMR」。公司開發和製造便攜式核磁共振(NMR)光譜儀或分析儀,面向實驗室和工業市場。NMReady-60是首個全功能便攜式NMR光譜儀,具有單一緊湊外殼,無需液氦或任何其他冷卻劑。公司在該初始產品推出之後又推出了新產品,並持續保持着強大的創新管道。2020年,公司宣佈推出其100MHz設備,這是迄今爲止市場上最強大、最先進的商用緊湊型NMR設備。

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.

公司的設備被廣泛應用於多個行業(石油和天然氣、化工、採礦、製藥、生物技術、香料和香氛、農化製品、執法等)以及全球衆多政府和大學研究實驗室。公司正在努力獨立及與合作伙伴一起擴展新的全球市場機會。公司通過其合作伙伴向全球提供科學設備銷售和維護服務。

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.

在2022年,公司獲得了一項爲期五年的合同,價值16000萬,提供加拿大機場乘客篩查設備的維護服務。這導致了公司安防服務業務的擴展。公司在加拿大每個省和地區提供機場安防設備維護服務。此外,公司還向北美的各類客戶提供商業安防設備安裝和維護服務。

About USP

關於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: .

USP是一個獨立的科學組織,與全球頂尖健康和科學專家合作,開發藥品、膳食補充劑和食品成分的質量資源和標準。這包括積極與學術研究中心、行業和監管機構合作,幫助採納和實施先進的製造技術。通過我們的資源、標準、倡導和教育,USP幫助全球數以十億計的人增加優質藥品、補充劑和食品的可用性。如需更多信息,請訪問:.

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.

在研究中使用具有USP-ID的Nanalysis NMR設備並不意味着USP對Nanalysis產品的批准、認可或認證,也不意味着Nanalysis產品必然是達成該目的的最佳可用產品,或者表明任何其他品牌或產品被判斷爲不合格或不足。作爲一個標準設定組織,USP避免可能干擾或看似干擾其公正性和客觀性的利益衝突。

Notice regarding Forward Looking Statements and Legal Disclaimer

關於前瞻性聲明和法律免責聲明的通知

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.

本新聞稿包含在適用證券法意義上的某些"前瞻性聲明"。前瞻性聲明通常由諸如"預期"、"計劃"、"繼續"、"期望"、"項目"、"打算"、"相信"、"估計"、"可能"、"將會"、"潛在"、"提議"、"定位"及其他類似詞彙,或某些事件或條件"可能"或"將會"發生的聲明所表徵。這些聲明僅僅是預測。基於各種假設作出了本新聞稿中前瞻性聲明所包含的結論或預測。前瞻性聲明基於管理層在聲明發布時的意見和估計,並受到各種風險、不確定性及其他因素的影響,這些因素可能導致實際事件或結果與前瞻性聲明中的預測有重大差異。公司不承擔更新或修訂任何前瞻性聲明的義務,並明確聲明無論是因新信息、未來事件或其他原因,均無此意圖或義務,除非法律明確要求。

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

無論是TSX風險投資交易所還是其監管服務提供者均不對本發佈的充分性或準確性承擔責任。

SOURCE Nanalysis Scientific Corp.

來源:Nanalysis Scientific Corp.

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