Ritedose启用先进实验室并扩展分析能力，以加速制药创新——将公司定位为药物开发和制造的首选合作伙伴-动脉网

Ritedose Opens Advanced Laboratory and Expands Analytical Capabilities to Accelerate Pharmaceutical Innovation—Positioning the Company as a Preferred Partner for Drug Development and Manufacturing

GlobeNewswire 等信源发布 2026-10-08 11:21

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Triples laboratory footprint with the $17 million investment.

通过1700万美元的投资，将实验室的占地面积扩大至原来的三倍。

Features new leachables and extractables testing capabilities.

新增浸出物和提取物检测能力。

Allows for seamless development and manufacturing experience while supporting pharmaceutical products throughout entire lifecycle.

支持药品在整个生命周期内的无缝开发与制造体验。

Creates an integrated laboratory infrastructure coupled with the Company’s microbiology laboratory expansion.

创建与公司微生物实验室扩建相配套的集成化实验室基础设施。

COLUMBIA, S.C., Oct. 08, 2026 (GLOBE NEWSWIRE) --

南卡罗来纳州哥伦比亚，2026年10月8日（环球电讯社）--

The Ritedose Corporation

Ritedose 公司

announced the opening of its new state-of-the-art current Good Manufacturing Practice (cGMP) laboratory, marking a major milestone in the Company's continued growth and reinforcing its position as a pharmaceutical manufacturing and life sciences innovation leader. The new analytical chemistry laboratory, coupled with the expansion of Ritedose's microbiology laboratory at its main manufacturing campus, creates a unique integrated laboratory infrastructure designed to support the Company's continued manufacturing growth while providing comprehensive, in-house analytical services..

宣布其全新的先进现行药品生产质量管理规范（cGMP）实验室正式启用，这标志着公司在持续增长道路上迈出的重要里程碑，并进一步巩固了其作为制药生产和生命科学创新领导者的地位。新的分析化学实验室与Ritedose在其主要生产基地的微生物实验室扩建相结合，构建了一个独特的集成化实验室基础设施，旨在支持公司持续的制造增长，同时提供全面的内部分析服务。

The more than $17 million investment in the new lab significantly expands Ritedose's analytical chemistry and microbiology capabilities, tripling the Company's laboratory footprint while creating one of the most advanced analytical testing environments in the Southeast. Located inside the newest facility inside Ritedose Performance Park, the lab strengthens the Company's ability to support pharmaceutical partners from early-stage development through commercial manufacturing, while expanding analytical services available to the broader life sciences community..

对新实验室的逾1,700万美元投资显著增强了Ritedose在分析化学和微生物学方面的能力，使公司的实验室面积扩大至原来的三倍，并打造出美国东南部最先进的分析测试环境之一。该实验室位于Ritedose Performance Park内最新建成的设施中，强化了公司支持制药合作伙伴从早期开发到商业化生产全过程的能力，同时向更广泛的生命科学社区扩展可用的分析服务。

'This investment represents much more than additional lab space—it's investing in the future of pharmaceutical innovation,' Ritedose president and CEO Jody Chastain said. 'As therapies become increasingly complex, our customers need partners with sophisticated analytical capabilities, scientific expertise and the capacity to move swiftly.

“这项投资远不止是增加实验室空间，它是对制药创新未来的投资，”Ritedose 总裁兼首席执行官 Jody Chastain 表示。“随着疗法日益复杂，我们的客户需要拥有先进分析能力、科学专业知识以及快速行动能力的合作伙伴。”

This facility enhances our ability to deliver all three while reinforcing our growing reputation as a destination for quality excellence and manufacturing innovation.'.

该设施提升了我们同时实现这三项目标的能力，并进一步巩固了我们作为卓越品质与制造创新目的地的日益增长的声誉。

A cornerstone of the expansion is Ritedose's comprehensive stability program, which features 10 qualified ICH stability chambers supporting long-term, accelerated, intermediate, refrigerated and controlled room temperature studies, as well as freeze-thaw and photostability testing. Together, these capabilities provide pharmaceutical partners with the data needed to demonstrate product quality, performance and shelf life while supporting regulatory submissions and commercial product lifecycle management..

此次扩建的核心是Ritedose全面的稳定性研究计划，该计划配备了10个符合ICH要求的验证稳定性试验箱，支持长期、加速、中间条件、冷藏及受控室温研究，以及冻融和光稳定性测试。这些能力共同为制药合作伙伴提供证明产品质量、性能和保质期所需的数据，同时支持监管申报和商业产品生命周期管理。

Combined, the laboratories strengthen Ritedose's capabilities in cGMP analytical testing, method development, method validation, product characterization, stability studies, raw material qualification, finished product release testing, as well as regulatory compliance. Equipped with advanced chromatographic, spectroscopic and mass spectrometric technologies, the laboratories support testing of raw materials, active pharmaceutical ingredients (APIs), excipients, packaging components, in-process materials and finished drug products.

这些实验室共同增强了 Ritedose 在 cGMP 分析测试、方法开发、方法验证、产品表征、稳定性研究、原材料资质确认、成品放行测试以及法规合规方面的能力。配备先进的色谱、光谱和质谱技术，这些实验室支持对原材料、活性药物成分（APIs）、辅料、包装组件、中间体和成品药物进行测试。

Advanced analytical services include extractables and leachables testing, nitrosamine detection, elemental analysis and comprehensive drug product de-formulation, supporting complex chemistry, manufacturing and controls (CMC) programs, bioequivalence studies and regulatory submissions..

高级分析服务包括可提取物和浸出物测试、亚硝胺检测、元素分析以及全面的药品逆向配方分析，支持复杂的化学、生产和控制（CMC）项目、生物等效性研究及监管申报。

“Our new laboratory combined with our updated microbiology capabilities streamlines our operations and gives customers the support they need from development through commercial manufacturing and long-term stability support,” continued Chastain. “Customers today expect a partner who can be there from start to finish.

“我们的新实验室结合更新后的微生物学能力，简化了我们的运营流程，并为客户提供从开发阶段到商业化生产以及长期稳定性支持所需的全方位支持。”Chastain继续说道，“如今的客户期望合作伙伴能够全程相伴，从起点到终点提供完整服务。”

We have the people, the capabilities and the infrastructure to do that—and to do it right the first time, every time.”.

我们拥有实现这一目标所需的人才、能力和基础设施，并确保每一次都能首次即正确地完成任务。

This builds upon several recent strategic investments by Ritedose, including the

这建立在Ritedose最近的几项战略投资之上，包括

expansion of sterile Blow-Fill-Seal (BFS) manufacturing capacity

无菌吹灌封（BFS）生产能力的扩张

, the

，这

addition of a seventh Syntegon packaging line

新增第七条Syntegon包装生产线

, and the opening of the Company's logistics and distribution center at Performance Park. Together, these investments strengthen Ritedose's ability to support pharmaceutical partners from clinical development through commercial supply while increasing manufacturing capacity to meet growing demand for sterile ophthalmic and respiratory therapies..

，以及公司在Performance Park的物流和分销中心的开业。这些投资共同增强了Ritedose支持制药合作伙伴从临床开发到商业供应的能力，同时提高了生产能力，以满足对无菌眼科和呼吸治疗产品日益增长的需求。

About The Ritedose Corporation

关于 Ritedose 公司

Ritedose is the largest sterile contract development manufacturing organization (CDMO) in the US specializing in sterile Blow Fill Seal (BFS) technology that ensures sterile, consistent, and safe unit dose delivery. The Company's process guides the development of molecules from clinical trials to commercialization of branded and generic inhalation and ophthalmic medications.

Ritedose 是美国最大的无菌合同研发生产组织（CDMO），专注于无菌吹灌封（BFS）技术，确保单剂量给药无菌、一致且安全。公司的流程引导分子从临床试验到品牌药和仿制药的吸入剂及眼科药物的商业化开发。

With a focus on quality, innovation, and customer satisfaction, Ritedose partners with leading pharmaceutical companies to deliver safe, effective, and reliable medications that improve patient outcomes. For more information about Ritedose and its services: visit .

Ritedose 以质量、创新和客户满意度为核心，与领先的制药公司合作，提供安全、有效且可靠的药物，以改善患者治疗结果。如需了解有关 Ritedose 及其服务的更多信息，请访问。

Ritedose.com

。

Media Contact

媒体联系人

Alex Keown

亚历克斯·基恩

On Behalf of The Ritedose Corporation

代表 Ritedose 公司

630-346-5141

akeown@inspire-agency.com

A photo accompanying this announcement is available at: