Alcami Launches New Rapid Sterility Testing Services

生物制药公司Alcami推出新的快速无菌测试服务

2019-10-09 10:00:31 CISION

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 Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biologics industries, today announced the launch of its new rapid sterility offering, a service that leverages cutting-edge microbiological testing technology to deliver significantly faster testing results to clients. Alcami invested in the Milliflex® Rapid System for the rapid sterility test, which uses adenosine triphosphate bioluminescence for detection of microorganisms after five days. "Our modern rapid sterility solution prominently positions Alcami on the frontline of contract laboratory services and aligns with our strategy to help reduce our customers' project timelines, from concept through commercialization," said Alcami Chief Commercial Officer Chad Telgenhof. "Few of our competitors offer rapid sterility capabilities, and even fewer use ATP-bioluminescence technology. We are pleased to introduce rapid sterility as an ideal way to meet our clients' tight timelines, and reduce or eliminate the need to pay rush fees for sterility tests." Rapid sterility is an alternative test method to the traditional United States Pharmacopeia (USP) General Chapter <71> sterility test that allows for shorter incubation periods and faster results to clients. Typical sterility tests require 14 days of incubation and use analyst observations to generate results, whereas rapid sterility tests need only five days of incubation, a 64% reduction in processing time. Rapid sterility is scientifically demonstrated to have comparable recovery to the harmonized USP <71> reference method. Like the reference method, microorganisms detected using the Milliflex Rapid System can later be identified to the species level. The technology also incorporates more sophisticated, computer-generated results, which eliminate observation bias. While the new Milliflex Rapid System is housed in Alcami's Wilmington, North Carolina advanced analytical testing technology center, its capabilities are expected to generate efficiencies across the organization, including faster batch releases from the company's Charleston, South Carolina clinical and commercial scale sterile manufacturing facility. "Faster release of drug product is extremely valuable to our clients, especially in cases of market shortage products," said Telgenhof. "We remain committed to helping our clients maintain uninterrupted supplies of their life-saving medicines for the patients around the world who rely on them." ABOUT ALCAMIAlcami is a world-class fully-integrated end-to-end contract development and manufacturing organization (CDMO) headquartered in North Carolina, with executive offices in Durham and Wilmington. With approximately 900 employees at nine locations worldwide, Alcami helps biologics and pharmaceutical companies of all sizes navigate the complex road of delivering breakthrough therapies to patients faster, from concept to commercialization. Alcami connects its global clients with customizable and innovative solutions for API development and manufacturing, solid state chemistry, formulation development, analytical development and testing services, clinical and commercial finished dosage form manufacturing (oral solid dose and parenteral), packaging, and stability services. For more information, please visit alcaminow.com. SOURCE Alcami Corporation Related Links http://www.alcaminow.com
Alcami 公司是一家为制药和生物制药行业提供完全集成定制端到端解决方案的领先供应商,今天宣布推出其新的快速无菌产品,这项服务利用尖端微生物检测技术,为客户提供更快的测试结果。Alcami 投资了 Milliflex ® Rapid 系统进行快速无菌测试,该系统使用三磷酸腺苷生物发光法检测五天后的微生物。 Alcami 首席商务官 Chad Telgenhof 说:“我们的现代快速无菌解决方案将 Alcami 置于合同实验室服务的前沿,并与我们的战略保持一致,以帮助减少客户的项目时间表,从概念到商业化。”“我们的竞争对手很少能提供快速的无菌能力,更少使用 ATP 生物发光技术。我们很高兴引入快速无菌作为满足客户严格的时间要求的理想方法,并减少或消除无菌试验的急诊费。” 快速无菌是传统美国药典( USP )总章<71>无菌试验的一种替代试验方法,它允许更短的潜伏期和更快的结果给客户。典型的无菌试验需要14天的孵化时间,并利用分析结果产生结果,而快速的无菌试验只需要5天的孵化时间,减少64%的处理时间。快速无菌被科学证明具有与协调 USP <71>参考方法相当的恢复。与参考方法一样,使用 Milliflex 快速系统检测到的微生物随后可以被识别到物种级别。该技术还结合了更复杂的计算机生成的结果,消除了观测偏差。 尽管新的 Milliflex 快速系统位于北卡罗来纳州威尔明顿的 Alcami's Wilmington ,它的能力有望在整个组织产生效率,包括公司的查尔斯顿,南卡罗来纳州临床和商业规模的无菌生产设施更快的批量发布。 “更快的释放药物产品对我们的客户是非常有价值的,尤其是在市场短缺的情况下,” Telgenhof 说。“我们仍然致力于帮助我们的客户为依赖他们的世界各地的患者保持他们的救命药品的不间断供应。” ALCAMIAlcami 是一家世界一流的、完全集成的端到端合同开发和制造组织( CDMO ),总部设在北卡罗来纳州,在达勒姆和威尔明顿设有执行办公室。Alcami 在全球9个地区拥有约900名员工,帮助生物制药公司和各种规模的制药公司更快地向患者提供突破性治疗,从概念到商业化。Alcami 为全球客户提供原料药(API)研发和制造、固态化学、制剂开发、分析开发和检测服务、临床和商业成品剂型制造(口服固体剂量和肠外制剂)、包装和稳定性服务的可定制和创新解决方案。

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