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
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).
卡尔加里,阿尔伯塔省,2024年12月11日 /PRNewswire/ - Nanalysis Scientific Corp.("公司",TSXV:NSCI,OTCQX:NSCIF,FRA:1N1),在工业和研究应用领域的便携式核磁共振仪器和MRI技术的领导者,宣布美国药典(USP)的一项研究结果,得出结论,台式NMR对于活性药物成分(API)的质量控制是有效的。
"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."
"在不久的将来,我们预计台式NMR将成为价值数十亿美元的药品质量控制市场中的一个重要工具," Nanalysis创始人兼首席执行官Sean Krakiwsky说。"NMR长期以来一直是分子水平测试的黄金标准。由于大型遗留NMR仪器的尺寸和要求,它们在许多环境中并不实用,例如大型生产/制造设施。我们的新型台式NMR产品提供高质量的数据,具有可靠性和便利性,由于其形态因素,适合这些应用。"
"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.
"我们的科学和产品团队在建立监管助力、降低生成和处理数据所需的专业知识、提高自动化以及在这一领域建立合作伙伴关系方面做得很好,"Krakiwsky先生继续说。
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的数字产品开发董事Ben Shapiro表示,"USP在开发处方药、非处方药和兽药的质量标准方面有着悠久的历史,以确保最高水平的质量。USP-ID的发布体现了我们利用创新技术自动化和规范化NMR数据的承诺,支持药品质量控制的现代化和数字化。像台式核磁共振(NMR)光谱这样的进步帮助使得测试方法,例如qNMR,变得更易获取和可扩展。"
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市场副总裁兼NMR产品经理Dr. Susanne D. Riegel表示,"我们一直在与USP密切合作,因为他们希望在药品行业的质量保证中现代化他们的专著和方法。尽管不像液相色谱等其他技术那么成熟,台式NMR可以带来以下好处:"
- 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
- 更快的测量
- 减少有害和昂贵溶剂的消耗
- 简单的样品准备
- 可以在无需校准的情况下进行
- 非破坏性和非特定性,提高测量的可靠性
"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.
"使用自动化分析方法,如USP-ID,降低了台式NMR进入药品/生物科技质量控制的门槛,并帮助建立这样做的价值主张。药品质量控制市场在全球每年达数十亿,我们预计数据监管要求将趋紧,因为对更一致和安全药品的需求正在增加。由于NMR已经变得小型化,它将成为这个市场的一个关键技术,因为它在可接触性、可负担性和自动化方面具有明显的优势。"
"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."
"我们公司继续提供创新的硬件和软件解决方案。通过与USP等组织建立良好的合作关系,在未来几年内,我们预计会向USP提交许多台式NMR方法以获得他们的认可,这将反过来驱动全球药品行业的QA/QC增长,同时我们还与其他药典管辖区合作,如欧洲和日本。"
Click on this link for full access to the USP publication:
点击此链接以获取USP出版物的完整访问权限:
About Nanalysis Scientific Corp. (TSXV: NSCI, OTCQX: NSCIF, FRA:1N1)
关于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. 主要运营两个业务部门:科学设备和安防服务。在其科学设备业务内,公司称之为“行业用MRI和NMR”。公司开发和制造便携式核磁共振(NMR)光谱仪或分析仪,面向实验室和工业市场。NMReady-60是首个全功能便携式NMR光谱仪,具有单一紧凑外壳,无需液氦或任何其他冷却剂。公司在该初始产品推出之后又推出了新产品,并持续保持着强大的创新管道。2020年,公司宣布推出其100MHz设备,这是迄今为止市场上最强大、最先进的商用紧凑型NMR设备。
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.
公司的设备被广泛应用于多个行业(石油和天然气、化工、采矿、制药、生物技术、香料和香氛、农化制品、执法等)以及全球众多政府和大学研究实验室。公司正在努力独立及与合作伙伴一起扩展新的全球市场机会。公司通过其合作伙伴向全球提供科学设备销售和维护服务。
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,公司获得了一项为期五年的合同,价值16000万,提供加拿大机场乘客筛查设备的维护服务。这导致了公司安防服务业务的扩展。公司在加拿大每个省和地区提供机场安防设备维护服务。此外,公司还向北美的各类客户提供商业安防设备安装和维护服务。
About USP
关于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是一个独立的科学组织,与全球顶尖健康和科学专家合作,开发药品、膳食补充剂和食品成分的质量资源和标准。这包括积极与学术研究中心、行业和监管机构合作,帮助采纳和实施先进的制造技术。通过我们的资源、标准、倡导和教育,USP帮助全球数以十亿计的人增加优质药品、补充剂和食品的可用性。如需更多信息,请访问:.
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设备并不意味着USP对Nanalysis产品的批准、认可或认证,也不意味着Nanalysis产品必然是达成该目的的最佳可用产品,或者表明任何其他品牌或产品被判断为不合格或不足。作为一个标准设定组织,USP避免可能干扰或看似干扰其公正性和客观性的利益冲突。
Notice regarding Forward Looking Statements and Legal Disclaimer
关于前瞻性声明和法律免责声明的通知
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.
本新闻稿包含在适用证券法意义上的某些"前瞻性声明"。前瞻性声明通常由诸如"预期"、"计划"、"继续"、"期望"、"项目"、"打算"、"相信"、"估计"、"可能"、"将会"、"潜在"、"提议"、"定位"及其他类似词汇,或某些事件或条件"可能"或"将会"发生的声明所表征。这些声明仅仅是预测。基于各种假设作出了本新闻稿中前瞻性声明所包含的结论或预测。前瞻性声明基于管理层在声明发布时的意见和估计,并受到各种风险、不确定性及其他因素的影响,这些因素可能导致实际事件或结果与前瞻性声明中的预测有重大差异。公司不承担更新或修订任何前瞻性声明的义务,并明确声明无论是因新信息、未来事件或其他原因,均无此意图或义务,除非法律明确要求。
Neither TSX Venture Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release.
无论是TSX风险投资交易所还是其监管服务提供者均不对本发布的充分性或准确性承担责任。
SOURCE Nanalysis Scientific Corp.
来源:Nanalysis Scientific Corp.