WOODBURY, Minn. & ST. LOUIS--(BUSINESS WIRE)--Kindeva Drug Delivery (Kindeva), a global leader in drug-device combination products, announced the expansion of its analytical services capabilities — launching a new global business unit offering integrated and stand-alone analytical support to the wider pharmaceutical, biopharmaceutical, and medical device sector.

明尼苏达州伍德伯里（WOODBURY）和圣路易斯（ST.LOUIS）——（商业新闻短讯）——Kindeva Drug Delivery（Kindeva），一家全球领先的药物器械组合产品公司，宣布扩大其分析服务能力——成立一个新的全球业务部门，为更广泛的制药、生物制药和医疗器械行业提供集成和独立的分析支持。

For more than half a century, Kindeva has developed significant knowledge, experience, and expertise working on inhaled, injectable, and transdermal drug delivery development programs and cGMP commercial supply. Additionally, Kindeva has built deep expertise and capability in cGMP analytical services supporting its product development and supply partners..

半个多世纪以来，金德瓦在吸入，注射和透皮给药开发计划和cGMP商业供应方面积累了丰富的知识，经验和专业知识。此外，金德瓦在cGMP分析服务方面建立了深厚的专业知识和能力，为其产品开发和供应合作伙伴提供支持。。

In addition to increasing Kindeva’s global analytical footprint, Kindeva’s recently opened 32,000-square-foot state-of-the-art laboratories in Woodbury, Minnesota, will serve as the central hub for its expanded suite of stand-alone analytical services. Kindeva’s Global Chief Commercial Officer Dave Stevens added: “Offering considerable analytical testing capabilities on a stand-alone basis to the wider pharmaceutical and device industry is an important step for Kindeva’s growing role as a global contract analytical, development, and manufacturing organization.

除了增加金德瓦的全球分析足迹外，金德瓦最近在明尼苏达州伍德伯里（Woodbury）开设了32000平方英尺的最先进实验室，将成为其扩展的独立分析服务套件的中心枢纽。金德瓦全球首席商务官戴夫·史蒂文斯补充道：“为更广泛的制药和设备行业提供独立的相当大的分析测试能力，是金德瓦作为全球合同分析、开发和制造组织日益重要的一步。

2024 is an exciting year for bringing many areas of needed industry solutions to fruition with the opening of a brand new world-class, state-of-the-art sterile injectable facility in Bridgeton, Missouri — capable of manufacturing more than 100M vials, cartridges, and syringes — as well as the operationalization of our first 152a green propellant-capable GMP capacity in Loughborough, U.K.

2024年是激动人心的一年，随着我们在密苏里州布里奇顿（Bridgeton，Missouri）开设了一家全新的世界级、最先进的无菌注射设施，能够生产超过1亿个小瓶、药筒和注射器，以及我们在英国拉夫堡（Loughborough）的首个具有152a绿色推进剂GMP能力的运营，许多领域所需的行业解决方案都取得了成果。

Expanding the analytical suite of capabilities and capacity reflects our ambition to be a true full-service partner and market leader in the CRO/CDMO industry and further accelerate the safety and efficacy objectives of innovators.”.

扩展分析套件的功能和能力反映了我们的雄心，即成为CRO/CDMO行业真正的全方位服务合作伙伴和市场领导者，并进一步加快创新者的安全性和有效性目标。”。

Kindeva will offer extractables and leachables, elemental impurities, medical device, and container closure integrity testing. Kindeva’s new container closure integrity testing to USP <1207> will be led by newly appointed Manager of Container Closure Integrity (CCI) and Medical Device Testing, Michael Dominguez, who recently joined Kindeva from DDL Testing.

Kindeva将提供可提取物和可浸出物、元素杂质、医疗器械和容器密封完整性测试。Kindeva针对USP 1207的新容器密封完整性测试将由新任命的容器密封完整性（CCI）和医疗器械测试经理Michael Dominguez领导，他最近从DDL测试加入Kindeva。

Dominguez brings deep expertise spanning a wide range of performance and functional medical device testing standards in deterministic CCI methods, including high voltage leak detection, vacuum decay, laser headspace analysis, and residual seal force testing. Kindeva’s extractables and leachables testing, and elemental impurities testing to ensure products comply with the ICH Q3D Guideline for Elemental Impurities, are led by Dan Dohmeier.

Dominguez在确定性CCI方法中带来了广泛的性能和功能医疗器械测试标准的深厚专业知识，包括高压泄漏检测，真空衰减，激光顶空分析和残余密封力测试。Kindeva的可提取物和浸出物测试以及元素杂质测试，以确保产品符合ICH Q3D元素杂质指南，由Dan Dohmeier领导。

Dohmeier’s team brings more than 60 years of extractables and leachables method development, validation, testing, and compound identification experience to address customer testing needs. Kindeva, including Dominguez and Dohmeier, will be available to meet in Anaheim, California, at the upcoming MD&M West on Feb.

Dohmeier的团队拥有60多年的可萃取和可浸出方法开发、验证、测试和化合物鉴定经验，以满足客户的测试需求。金德瓦（Kindeva），包括多明格斯（Dominguez）和多梅耶（Dohmeier），将于2月1日在加利福尼亚州阿纳海姆（Anaheim）即将举行的MD&M West会议上会面。

6-8, 2024, in Booth #972. For a complete listing of Kindeva’s analytical services, visit https://www.kindevadd.com/analytical-services/..

2024年6月8日，展位号#972。有关Kindeva分析服务的完整列表，请访问https://www.kindevadd.com/analytical-services/..

About Kindeva Drug Delivery

关于Kindeva药物输送

Kindeva Drug Delivery is a global contract development and manufacturing organization focused on drug-device combination products. We develop and manufacture products across a broad range of drug-delivery formats, including pulmonary & nasal, injectable, and transdermal. Our service offerings span early-stage feasibility through commercial scale drug product fill-finish, container closure system manufacturing, and drug-device product assembly.

Kindeva Drug Delivery是一家专注于药物-器械组合产品的全球合同开发和制造组织。我们开发和制造各种药物输送形式的产品，包括肺和鼻，注射和透皮。我们的服务涵盖了商业规模的药品填充完成，容器封闭系统制造和药品装置产品组装的早期可行性。

Kindeva serves a global client base from our state-of-the-art manufacturing, research, and development facilities located across the U.S. and U.K..

金德瓦公司在美国和英国拥有最先进的制造、研究和开发设施，为全球客户提供服务。。