病毒学检测

Regulatory agencies require proof of efficacy against specified pathogens before approving public health label claims. Proof of efficacy has become especially important during the global COVID-19 pandemic.

Expand your product efficacy claims with the support of im体育APP’s consultative experts. Options for virology testing range from preliminary screening to the required GLP tests for submission, and we offer a wide array of BSL2 and BSL3 human and veterinary viruses to support your claims. Our comprehensive viral efficacy testing services serve the anti微生物 industry, and our offerings are constantly evolving to meet industry and public health needs, including testing against SARS-CoV-2 (Alpha (B.1.1.7), Delta and Omicron variants), the causative agent of COVID-19. Experienced scientists with years of virology experience have deep knowledge and expertise in working with a wide variety of viruses and methods. Our responsive teams consistently meet the needs of our clients, delivering high quality results in a timely fashion. 

im体育APP’s GLP laboratories have extensive experience supporting the successful registration of products. Meet submission requirements for regulatory bodies worldwide, including the 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), and US 食物 and Drug Administration (FDA) with im体育APP by your side. We also offer non-GLP testing to support products in development, as well as to support products for which regulatory agencies do not require GLP testing or reports for submission

Our virology efficacy testing complements our analytical chemistry and microbiology efficacy testing services with product test methods for use with viruses commonly requested for use in household, 医院, and veterinary spaces. If you have a specific method in mind that is not listed as an offering, 请, 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

Our GLP-compliant virology testing complements our anti微生物 efficacy testing services through product tests against viruses commonly requested for use in household, 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. In addition to providing best-in-class virucidal anti微生物 pesticide device testing services, our consultative anti微生物 testing experts can help you to navigate the complex regulations surrounding anti微生物 devices confidently and successfully.

Residual virucidal efficacy testing – 产品s that provide continuous protection against viruses for days, 周, or months must meet EPA regulations and guidance for virucidal efficacy claims. im体育APP’s knowledgeable anti微生物 experts can test products to a wide range of established methodology or develop custom testing protocols to meet your specific needs.

Treated article virucidal efficacy testing – Navigating EPA regulations for articles treated with anti微生物 pesticides intended to preserve or protect the article itself can be challenging. With over three decades of experience testing treated articles, our responsive and knowledgeable team can test treated articles to established methods or develop custom protocols to meet your treated article testing needs.

Virucidal EN testing – 欧洲an countries and other jurisdictions require the evaluation of biocidal products for virucidal activity using 欧洲an Standards biocidal products. With deep expertise in testing to EN standards for virucidal activity, we offer virucidal EN testing to a range of established methods. Custom EN methods or other EN methods may be considered or tailored to meet the distinct testing needs for a specific product for ECHA registration.

Virucidal disinfectant testing ——在美国, data demonstrating antiviral activity must be generated to support disinfectant and sanitizing claims, which are regulated by the EPA. For more than 30 years, im体育APP has assessed the efficacy of sanitizing and disinfectant products against microorganisms and viruses to established methods and custom testing protocols.

cGMP virology testing

Our cGMP-compliant molecular cell biology and virology testing complements our pharmaceutical product testing and includes mycoplasma, cytotoxin and endotoxin testing, among other services.

USP <63>, EP 2.6.7 Mycoplasma Tests – im体育APP's virology testing experts offer mycoplasma tests to established methodology, 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's GMP virology testing for 微生物 contaminants includes sterility and mycoplasma tests. This includes retroviruses, adventitious viruses, 内毒素:拉尔, 剩余DNase, RNase and protease activities. We can also test cells at the limit of in vitro cell age or end of production cells, in addition to unprocessed bulk and final filled product samples.