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 Element’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 antimicrobial 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.
Element’s GLP laboratories have extensive experience supporting the successful registration of products. Meet submission requirements for regulatory bodies worldwide, including the US Environmental Protection Agency (EPA), Health Canada, Australian Therapeutic Goods Administration (TGA), European Chemicals Agency (EN), and US Food and Drug Administration (FDA) with Element 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, hospital, and veterinary spaces. If you have a specific method in mind that is not listed as an offering, please ask, 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, contact us today.
GLP virology testing
Our GLP-compliant virology testing complements our antimicrobial efficacy testing services through product tests against viruses commonly requested for use in household, hospital and veterinary spaces.
Antimicrobial pesticide device testing – Devices that act as an antimicrobial, or that produce an antimicrobial product, can be regulated by either the EPA or the FDA. In addition to providing best-in-class virucidal antimicrobial pesticide device testing services, our consultative antimicrobial testing experts can help you to navigate the complex regulations surrounding antimicrobial devices confidently and successfully.
Residual virucidal efficacy testing – Products that provide continuous protection against viruses for days, weeks, or months must meet EPA regulations and guidance for virucidal efficacy claims. Element’s knowledgeable antimicrobial 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 antimicrobial 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 – European countries and other jurisdictions require the evaluation of biocidal products for virucidal activity using European 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 – In the US, data demonstrating antiviral activity must be generated to support disinfectant and sanitizing claims, which are regulated by the EPA. For more than 30 years, Element 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 – Element's virology testing experts offer mycoplasma tests to established methodology, including USP <6> and Ph. Eur./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.
Custom studies– 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 – Element's GMP virology testing for microbial contaminants includes sterility and mycoplasma tests. This includes retroviruses, adventitious viruses, endotoxin: LAL, residual 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.
|Avian Influenza A (H7N9) virus||CDC # 2013759189||Wildtype A/Anhui/1/2013|
|Avian Influenza A (H5N1) virus (avian)||CDC # 2006719965||VNH5N1-PR8/CDC-RG|
|Bovine Viral diarrhea virus||NVSL||Oregon c24v-genotype 1, cytopathic|
|Canine Influenza (H3N8) virus||Cornell University||A/Ca/NY/105913/08|
|Duck Hepatitis B virus||Hepadnavirus Testing|
|Enterovirus type D68||VR-1825||US/KY/14-18953|
|Equine Herpesvirus type 1||NVSL||EHv1|
|Equine Herpesvirus type 3 (EHV3)||NVSL||Coital Exanthema|
|Equine Influenza type A2||NVSL||A/Equine/Miami/1/63|
|Hepatitis A||AppTec Laboratory Services||HM-175|
|Hepatitis B virus surrogate||Hepadnavirus Testing||Various|
|Hepatitis C virus surrogate||NVSL||Oregon c24v-genotype 1|
|Human immunodeficiency virus type 1 (HIV-1)||Advanced Biotechnologies||HTLV IIIB|
|Avian Infectious bronchitis virus||Solvay Animal Health||Beaudette IB42|
|Avian Infectious bursal disease virus||NVSL||Edgar|
|Infectious bursal disease virus||Solvay Animal Health|
|Infectious laryngotracheitis (LT virus)||Poultry Health Specialties||LT-IVAX (Modified live vaccine)|
|Influenza A||CDC # 99013257||A/Panama/2007/99|
|Influenza A||CDC (ARTS)||Beijing H1N1|
|2009 H1N1 influenza A (Novel H1N1) virus||CDC # 2009712192||A/Mexico/4108/2009|
|Influenza A (H1N2) virus||CDC # 2002704198||A/Hawaii/10/02|
|Avian Influenza A (H5N1) virus (avian)||CDC # 2006719965||VNH5N1-PR8/CDC-RG|
|Influenza B||CDC # 2001701830||B/HongKong/330/01|
|Poliovirus type 1||CDC||Sabin 1 NIBSC 01/528 (LSc-2ab)|
|Porcine epidemic diarrhea virus||NVSL||Colorado 2013 Isolate|
|Porcine Reproductive & respiratory syndrome (PRRS)||University of Kentucky||NVSL|
|Transmissible gastroenteritis virus (TGE)||Univeristy of Minnesota|
Antimicrobial testing performed in Element laboratories has supported the successful registration of thousands of antimicrobial products.
Element’s pharmaceutical laboratories provide specialist pharmaceutical testing services, including chemical, physical, microbial, and stability testing on a vast array of products, from raw materials to finished products.
White Paper: Mycoplasma Safety Testing in Pharmaceutical Products
Contaminated cell cultures and products have the potential to cause serious illness in humans. Download our white paper at the link below for an overview of mycoplasma testing and considerations to address when executing these studies.
Secure 24/7 access to your test result information, which you can download directly to your information management system.
About Element Eagan
Element Eagan is the premier contract antimicrobial testing laboratory and expert partner to the developers, manufacturers and users of antimicrobial pesticide and biocide products. We have more than 30 years of experience generating GLP-compliant data.
About Element Concord
Element Concord is an industry leader in providing USP <71> sterility and rapid sterility testing, viral safety testing, and custom microbiology testing services to the developers and manufacturers of pharmaceutical products.
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