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Stevanato Group推出EZ-fill®试剂盒和实验室填充和完成服务,以支持小批量药物开发和商业化

Stevanato Group Launches EZ-fill® Kit and Laboratory Fill and Finish Service to Support Small Batch Drug Development and Commercialization

businesswire 等信源发布 2024-01-24 20:00

可切换为仅中文


PIOMBINO DESE, Italy--(BUSINESS WIRE)--Stevanato Group S.p.A. (NYSE: STVN), a leading global provider of drug containment and delivery solutions to the pharmaceutical, biotechnology, and life sciences industries, unveiled today two new offerings for efficient small batch pharmaceutical manufacturing: the EZ-fill® Kit and the non-GMP laboratory fill and finish service at its Technology Excellence Centers (TEC)..

意大利PIOMBINO DESE——(商业新闻短讯)——Stevanato Group S.p.A.(纽约证券交易所:STVN),一家为制药、生物技术和生命科学行业提供药物遏制和输送解决方案的全球领先供应商,今天推出了两种高效小批量制药的新产品:EZ fill®试剂盒和其技术卓越中心(TEC)的非GMP实验室填充和完成服务。。

In a context where reducing time-to-market is key, Stevanato Group’s new EZ-fill® Kit offers fast access to a customizable and versatile solution to pharma and biotech companies needing to efficiently fill small batches with high-quality injectable formulations during clinical trials or commercial phases..

在缩短上市时间至关重要的情况下,Stevanato Group的新型EZ-fill®试剂盒为制药和生物技术公司提供了快速定制和多功能的解决方案,这些公司需要在临床试验或商业阶段用高质量的可注射制剂有效地填充小批次。。

The surge the industry has seen in biopharmaceuticals treating various diseases in several therapeutical areas may signal a significant growth potential for pharmaceutical companies. Injectables, comprising more than 60% of the over 21,000 drugs currently in development, of which 44% are biopharmaceuticals, require high-performance primary packaging and delivery technologies for proper storage and administration..

该行业在几个治疗领域治疗各种疾病的生物制药领域的激增可能标志着制药公司的巨大增长潜力。注射剂占目前正在开发的21000多种药物的60%以上,其中44%是生物制药,需要高性能的初级包装和输送技术才能正确储存和管理。。

Stevanato Group’s EZ-fill® Kit builds on its existing ready-to-use platform of pre-sterilized containment solutions – vials, cartridges, and syringes – allowing customers to effectively screen different primary packaging in combination with drug products. The kit will be available as a modular box made up of glass ready-to-use drug containers and add-on components on request, shipped by courier.

Stevanato Group的EZ fill®试剂盒建立在其现有的即用即用平台上,该平台包含预灭菌的容器溶液(小瓶、药筒和注射器),使客户能够有效地筛选与药品组合的不同初级包装。该套件将作为模块化盒子提供,由玻璃即用药物容器和附加组件组成,可根据要求由快递公司运送。

As a result, the platform can bring enhanced levels of quality and safety to patients across the entire drug life cycle and improve the rate at which new drugs enter the market. EZ-fill® Kit will be presented at Pharmapack and is expected to be available commercially beginning in the second quarter of 2024..

因此,该平台可以在整个药物生命周期中为患者带来更高水平的质量和安全性,并提高新药进入市场的速度。EZ-fill®试剂盒将在Pharmapack上展出,预计将于2024年第二季度开始商业化。。

Additionally, to better support customers, Stevanato Group has introduced a non-GMP laboratory filling and finishing service at its Technology Excellence Centers (TEC) in Boston, USA, and Piombino Dese, Italy. This new service allows customers to assess and identify the possible effects of the fill-and-finish process on their product performance as early as the container selection stage, thus de-risking processes and enhancing development and commercialization strategy..

此外,为了更好地支持客户,Stevanato集团在其位于美国波士顿和意大利Piombino Dese的技术卓越中心(TEC)推出了非GMP实验室填充和整理服务。这项新服务使客户能够在容器选择阶段就评估和确定填充和完成过程对其产品性能的可能影响,从而降低过程风险,增强开发和商业化战略。。

“In the race to bring new advanced biopharmaceutical products to market and to patients, Stevanato Group is tackling the challenge of supporting customers with flexible drug containment and filling solutions in a timely manner,' says Fabio Bertacchini, Senior Director EZ-fill® Vials & Cartridges at Stevanato Group.

Stevanato Group EZ fill®Vials&Cartridge高级总监法比奥·贝尔塔奇尼(Fabio Bertacchini)表示:“在将新的先进生物制药产品推向市场和患者的竞赛中,Stevanato Group正在应对及时为客户提供灵活的药物控制和灌装解决方案的挑战。”。

'Stevanato Group remains focused on developing new offerings that can help raise pharmaceutical manufacturing standards. By leveraging the expertise provided by our global TEC Centers, we aim to support customers' innovation, helping them face tests and de-risking processes and making right-the-first-time choices throughout their drug development journey.”.

Stevanato集团仍然专注于开发有助于提高制药制造标准的新产品。通过利用我们全球技术中心提供的专业知识,我们的目标是支持客户的创新,帮助他们面对测试和降低风险的过程,并在整个药物开发过程中做出正确的第一次选择。”。

For more information on Stevanato Group’s EZ-fill® Kit, visit www.stevanatogroup.com and visit us at Pharmapack booth F46.

有关Stevanato Group EZ fill®试剂盒的更多信息,请访问www.stevanatogroup.com,并访问Pharmapack展位F46。

* Pharmaprojects 2023 | Pharma R&D Annual Review 2023.

*Pharmaprojects 2023 | Pharma R&D Annual Review 2023。

Forward-Looking Statements

前瞻性声明

This press release may include forward-looking statements. The words 'may,” “potential,” “offers,” “will be,” “can,” “is expected,” “remains,” “aim,” and similar expressions (or their negative) identify certain of these forward-looking statements. These forward-looking statements are statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, investments the Company expects to make, the expansion of manufacturing capacity, the Company’s plans regarding its presence in the U.S., business strategies, the Company’s capacity to meet future market demands and support preparedness for future public health emergencies, and results of operations.

本新闻稿可能包括前瞻性声明。“可能”、“潜在”、“提议”、“将是”、“可以”、“预期”、“保留”、“目标”以及类似的表达(或其负面)都可以识别这些前瞻性陈述中的某些。这些前瞻性声明是关于公司的意图、信念或当前期望的声明,其中包括公司预期进行的投资、制造能力的扩大、公司在美国的业务计划、商业战略、,公司满足未来市场需求和支持未来公共卫生突发事件准备的能力以及运营结果。

The forward-looking statements in this press release are based on numerous assumptions regarding the Company’s present and future business strategies and the environment in which the Company will operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements of the Company to be materially different from those expressed or implied by such forward looking statements.

本新闻稿中的前瞻性陈述基于对公司当前和未来业务战略以及公司未来运营环境的众多假设。前瞻性陈述涉及固有的已知和未知风险、不确定性和或有事项,因为它们与事件有关,取决于未来可能发生或不可能发生的情况,并可能导致公司的实际结果、业绩或成就与此类前瞻性陈述明示或暗示的结果、业绩或成就存在重大差异。

Many of these risks and uncertainties relate to factors that are beyond the Company's ability to control or estimate precisely, such as future market conditions, currency fluctuations, the behavior of other market participants, the actions of regulators and other factors such as the Company's ability to continue to obtain financing to meet its liquidity needs, changes in the political, social and regulatory framework in which the Company operates or in economic or technological trends or conditions.

其中许多风险和不确定性与公司无法精确控制或估计的因素有关,例如未来市场状况、货币波动、其他市场参与者的行为、监管机构的行动以及其他因素,例如公司继续获得融资以满足其流动性需求的能力、政治变化、,公司运营或处于经济或技术趋势或条件下的社会和监管框架。

Readers.

读者。

About Stevanato Group

关于Stevanato集团

Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages.

Stevanato集团成立于1949年,是一家为制药、生物技术和生命科学行业提供药物遏制、药物输送和诊断解决方案的全球领先供应商。该集团提供完整的端到端产品、流程和服务组合,以满足客户在整个药物生命周期的每个开发、临床和商业阶段的需求。

Stevanato Group’s core capabilities in scientific research and development, its commitment to technical innovation and its engineering excellence are central to its ability to offer value added solutions to clients. To learn more, visit: www.stevanatogroup.com..

Stevanato集团在科学研究和开发方面的核心能力、对技术创新的承诺以及卓越的工程技术是其向客户提供增值解决方案能力的核心。要了解更多信息,请访问:www.stevanatogroup.com。。