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.
|Adenovirus type 2||ATCC VR-846||Adenoid 6|
|Adenovirus type 3||ATCC VR-847||G.B.|
|Adenovirus type 4||ATCC VR-4||RI-67|
|Adenovirus type 5||ATCC VR-5||Adenoid 75|
|Adenovirus type 8||ATCC VR-1368||Trim|
|Adenovirus type 14||ATCC VR-15||deWit|
|Adenovirus type 19||ATCC VR-254||AV-587 (3911)|
|Adenovirus type 35||ATCC VR-718||Holden|
|Avian Adenovirus||ATCC VR-280||Fontes|
|Avian Influenza A (H7N9) virus||CDC # 2013759189||Wildtype A/Anhui/1/2013|
|Avian Influenza A (H5N1) virus (avian)||CDC # 2006719965||VNH5N1-PR8/CDC-RG|
|Avian Retrovirus||ATCC VR-2449||2177|
|Bovine Enterovirus type 1||ATCC VR-248||LCR 4|
|Bovine herpes mammillitis virus||ATCC VR-845||New York 1|
|Bovine Parainfluenza virus type 3||ATCC VR-281||SF-4|
|Bovine Parvovirus||ATCC VR-767||Haden|
|Bovine Rotavirus||ATCC VR-2102||WC-3 (R402-10)|
|Bovine Viral diarrhea virus||NVSL||Oregon c24v-genotype 1, cytopathic|
|Bovine Viral diarrhea virus||ATCC VR-1422||NADL|
|Canine Adenovirus||ATCC VR-800||Toronto A 26/61|
|Canine Coronavirus||ATCC VR-809||1-71|
|Canine Distemper||ATCC VR-128||Lederle|
|Canine Influenza (H3N8) virus||Cornell University||A/Ca/NY/105913/08|
|Canine Parainfluenza||ATCC VR-666||Penn 103/70|
|Canine Parvovirus||ATCC VR-2017||Cornell|
|Chlamydia psittaci (psittacosis)||ATCC VR-125||6 BC|
|Chlamydia trachomatis (Serotype K)||ATCC VR-887||UW-31/Cx|
|Coronavirus (human)||ATCC VR-740||229E|
|Coxsackievirus type A16||ATCC VR-174||G10 (Suspension-based testing only)|
|Coxsackievirus type B3||ATCC VR-30||Nancy|
|Duck Hepatitis B virus||Hepadnavirus Testing|
|Echovirus type 6||ATCC VR-36||D’Amori|
|Echovirus type 11||ATCC VR-41||Gregory|
|Echovirus type 12||ATCC VR-1563||Travis 2-85|
|Enterovirus type D68||VR-1825||US/KY/14-18953|
|Enterovirus type 70||ATCC VR-836||J670/71 (Suspension-based testing only)|
|Enterovirus type 71||ATCC VR-784||BrCr|
|Equine Arteritis virus||ATCC VR-796||Bucyrus|
|Equine Herpesvirus type 1||NVSL||EHv1|
|Equine Herpesvirus type 1||ATCC VR-2229||438/79|
|Equine Herpesvirus type 3 (EHV3)||NVSL||Coital Exanthema|
|Equine Influenza type A2||NVSL||A/Equine/Miami/1/63|
|Feline Calicivirus||ATCC VR-782||F-9|
|Feline Herpesvirus (Feline rhinotracheitis)||ATCC VR-636||C-27|
|Feline Infectious peritonitis||ATCC VR-2202||FIPV-1146, P100|
|Feline Panleukopenia||ATCC VR-648||Philips-Roxane|
|Feline Picornavirus||ATCC VR-649||FRV (17FRV)|
|Hepatitis A||AppTec Laboratory Services||HM-175|
|Hepatitis B virus surrogate||Hepadnavirus Testing||Various|
|Hepatitis C virus surrogate||NVSL||Oregon c24v-genotype 1|
|Herpes simplex virus type 1||ATCC VR-733||F(1)|
|Herpes simplex virus type 2||ATCC VR-734||G|
|Human immunodeficiency virus type 1 (HIV-1)||Advanced Biotechnologies||HTLV IIIB|
|Human rotavirus||ATCC VR-2018||WA|
|Infectious bovine rhinotracheitis (IBR)||ATCC VR-188||LA|
|Avian Infectious bronchitis virus||Solvay Animal Health||Beaudette IB42|
|Avian Infectious bursal disease virus||NVSL||Edgar|
|Infectious bursal disease virus||Solvay Animal Health|
|Infectious canine hepatitis||ATCC VR-293||Utrecht|
|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|
|Influenza A||ATCC VR-1469||A/PR/8/34|
|Influenza A||ATCC VR-544||A/HongKong/8/68|
|Influenza A (H1N1) virus||ATCC VR-98||A/Malaya/302/54|
|Influenza A (H3N2) virus||ATCC CDC# 2012701539||A/West Virginia/06/2011|
|2009 H1N1 influenza A (Novel H1N1) virus||CDC # 2009712192||A/Mexico/4108/2009|
|Influenza A (H1N2) virus||CDC # 2002704198||A/Hawaii/10/02|
|Influenza A (H3N2) Reassortant (Avian/Human)||ATCC VR-2072||A/Washington/897/80 x A/Mallard/New York/6750/78|
|Avian Influenza A (H5N1) virus (avian)||CDC # 2006719965||VNH5N1-PR8/CDC-RG|
|Influenza B||ATCC VR-823||B/Hong Kong/5/72|
|Influenza B||CDC # 2001701830||B/HongKong/330/01|
|Kilham rat virus||ATCC VR-1790||Kilham (RV-13)|
|Minute virus of mice||ATCC VR-1346||Prototype (p)|
|Mouse Hepatitis virus||ATCC VR-765||MHV-JHM|
|Norovirus surrogate||ATCC VR-782||F-9|
|Parainfluenza type 3||ATCC VR-93||C243|
|Poliovirus type 1||CDC||Sabin 1 NIBSC 01/528 (LSc-2ab)|
|Poliovirus type 1||ATCC VR-1562||Chat|
|Porcine epidemic diarrhea virus||NVSL||Colorado 2013 Isolate|
|Porcine Parvovirus||ATCC VR-742||NADL-2|
|Porcine Reproductive & respiratory syndrome (PRRS)||University of Kentucky||NVSL|
|Porcine Rotavirus||ATCC VR-893||OSU (attenuated)|
|Reovirus type 3||ATCC VR-232||Abney|
|Respiratory syncytial virus (Human)||ATCC VR-26||Long|
|Rhinovirus type 1A||ATCC VR-1559||2060|
|Rhinovirus type 2||ATCC VR-482||HGP|
|Rhinovirus type 14||ATCC VR-284||1059|
|Rhinovirus type 16||ATCC VR-283||11757|
|Rhinovirus type 37||ATCC VR-1147||151-1|
|Rhinovirus type 39||ATCC VR-340||209|
|Rotavirus||ATCC VR-2018||Wa strain|
|Rotavirus||ATCC VR-2272||HRV 89-12c2 strain|
|Swine Influenza A||ATCC VR-333||A/Swine/Iowa/15/30|
|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.
Sign Up for Free Resources
Visit Element's email subscription center to receive the latest industry news, technical whitepapers, case studies, webinars, and upcoming events.