监管机构在批准公共健康标签声明之前需要证明对特定病原体的有效性. 在全球COVID-19大流行期间,疗效证明变得尤为重要.

im体育APP咨询专家的支持下,扩展您的产品功效声明. 病毒学测试的选择范围从初步筛选到提交所需的GLP测试, 我们还提供多种BSL2和BSL3人类和兽医病毒,以支持您的说法. 我们全面的病毒功效测试服务于抗菌药物im体育平台app下载, 我们的产品不断发展,以满足im体育平台app下载和公共卫生需求, including testing against SARS-CoV-2 (Alpha (B.1.1.7), Delta and Omicron variants), the causative agent of COVID-19. 具有多年病毒学经验的经验丰富的科学家在处理各种病毒和方法方面具有深厚的知识和专长. Our responsive teams consistently meet the needs of our clients, delivering high quality results in a timely fashion. 

im体育APP的GLP实验室在支持产品成功注册方面拥有丰富的经验. 满足全球监管机构的提交要求,包括 US 环境 Protection Agency (EPA), 加拿大卫生部, 澳大利亚n Therapeutic Goods Administration 矫正性大动脉转位(TGA), 欧洲an Chemicals Agency (EN)和美国食品和药物管理局(FDA), im体育APP在您身边. We also offer non-GLP testing to support products in development, 以及支持监管机构不要求进行GLP测试或提交报告的产品

我们的病毒学功效测试补充了我们的分析化学和微生物功效测试服务,产品测试方法适用于家庭中常用的病毒, 医院, and veterinary spaces. 如果你心中有一个具体的方法,但没有列在报价中, , as we are always looking for new ways to partner with our clients.

For more information about our GLP or cGMP virology testing services, information about additional methodology or to request a quote, im体育APP 今天.

GLP virology testing

我们符合glp标准的病毒学测试通过对家庭常用病毒的产品测试来补充我们的抗菌功效测试服务, 医院 and veterinary spaces.

抗菌 pesticide device testing – Devices that act as an anti微生物, or that produce an anti微生物 product, can be regulated by either the EPA or the FDA. 除了提供一流的杀毒抗菌农药器械检测服务, 我们的咨询抗菌测试专家可以帮助您自信和成功地驾驭围绕抗菌设备的复杂法规.

Residual virucidal efficacy testing – 产品s that provide continuous protection against viruses for days, 周, 六个月的时间必须符合EPA的规定和指导方针. im体育APP知识渊博的抗菌专家可以根据广泛的既定方法测试产品或开发自定义测试协议,以满足您的特定需求.

Treated article virucidal efficacy testing -使用抗菌农药处理物品的EPA法规旨在保存或保护物品本身,这可能具有挑战性. With over three decades of experience testing treated articles, 我们的响应和知识渊博的团队可以根据既定的方法测试处理过的物品或开发自定义协议,以满足您的处理过的物品测试需求.

Virucidal EN testing -欧洲国家和其他司法管辖区要求使用欧洲标准杀菌剂产品对杀菌剂产品的杀毒活性进行评估. With deep expertise in testing to EN standards for virucidal activity, we offer virucidal EN testing to a range of established methods. 定制EN方法或其他EN方法可以考虑或定制,以满足ECHA注册特定产品的不同测试需求.

Virucidal disinfectant testing ——在美国, 证明抗病毒活性的数据必须生成,以支持消毒剂和消毒的说法, which are regulated by the EPA. For more than 30 years, 根据既定的方法和定制的测试协议,im体育APP评估了消毒和消毒产品对微生物和病毒的功效.

cGMP virology testing

我们符合cgmp的分子细胞生物学和病毒学测试补充了我们的药物产品测试,包括支原体, cytotoxin and endotoxin testing, among other services.

USP <63>, EP 2.6.7 Mycoplasma Tests - im体育APP的病毒学检测专家根据既定方法提供支原体检测, including USP <6> and Ph. 欧元./EP 2.6.7.

USP <87> Biological Reactivity Tests, ISO 10993-5, Cytotoxicity – We have decades of experience performing biological reactivity tests to USP <87> in addition to cytotoxicity testing per ISO 10993-5. 

自定义的研究– We can develop custom studies to meet your specific needs. Services include assay development and validation, cell line generation, potency and safety testing, as well as impurity, and safety testing. 

Microbiological contaminants – im体育APP对微生物污染物的GMP病毒学测试包括无菌和支原体测试. This includes retroviruses, adventitious viruses, 内毒素:拉尔, 剩余DNase, RNase and protease activities. 我们也可以在体外细胞年龄限制或生产细胞结束时测试细胞, in addition to unprocessed bulk and final filled product samples. 

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抗菌 testing

抗菌 测试

im体育APP实验室进行的抗菌测试支持了数千种抗菌产品的成功注册.

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pharmaceutical testing

Pharmaceutical 测试

im体育APP的药物实验室提供专业的药物测试服务, including chemical, 物理, 微生物, and stability testing on a vast array of products, from raw materials to finished products.

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Mycoplasma Safety 测试

White Paper: Mycoplasma Safety 测试 in Pharmaceutical 产品s

受污染的细胞培养物和产品有可能导致人类严重疾病. 在下面的链接下载我们的白皮书,了解支原体测试的概述和执行这些研究时要考虑的问题.

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抗菌 testing

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Secure 24/7 access to your test result information, which you can download directly to your information management system.

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抗菌 testing

关于im体育APP Eagan

im体育APP Eagan是首屈一指的合同抗菌测试实验室和开发人员的专家合作伙伴, 抗微生物农药和杀菌剂产品的制造商和用户. 我们有超过30年的经验生成符合glp的数据.

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关于im体育APP Concord

im体育APP Concord is an industry leader in providing USP <71> sterility and rapid sterility testing, viral safety testing, 并为医药产品的开发商和制造商提供定制微生物检测服务.

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