45-1 Ramsey Road, Shirley, NY 11967, USA 1-631-614-7828 1-631-372-1052

Toxicology

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Viral Testing

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In biopharmaceutical industry, viral contamination is a major concern affecting product safety and batch release by using mammalian cell lines. For example, adventitious viruses could accidentally be introduced by external factors, operators, or using contaminated cell culture media or reagents during the production process. In addition, many biological products from animal sources may be contaminated because there are a variety of latent infection viruses in animals. According to the regulations of international conference on harmonization (ICH), raw materials, intermediate and final products of biologics should be undertook viral testing, such as cell lines/banks, monoclonal antibodies, virus seeds, unprocessed bulk, and vector supernatant.

Adventitious Viral Assays
The viral testing is essential in the biosafety package for any biopharmaceutical product. Creative Animodel provides a portfolio of in vivo and in vitro viral testing services which can be chosen and customized to meet your specific needs. Our viral tests can be conducted for viruses such as herpes simplex viruses (HSV), varicella-zoster viruses (VSV), hepatitis viruses, human papillomaviruses (HPV), influenza viruses, cytomegaloviruses (CMV) and so on. Our services include but are not limited to:

In Vivo assaysIn Vitro assays
Mouse antibody production (MAP) testHamster antibody production (HAP) testRat antibody production (RAP) testSpecific assays for vaccine testing14 and 18 day adventitious virus assaysPorcine and bovine adventitious virus assaysSpecies-specific viral PCR assaysCustomized assays  addressing specific contamination risks

Retrovirus Assays
Retroviruses are a family of viruses with an extremely complicated life cycle. Their RNA are reverse transcribed into DNA and integrated into the host genome (when they become proviruses). Therefore, retroviruses are of particular concern as they are often present in an endogenous form in many cell lines. The ICH guidelines describe tests for retroviruses which are applied to three stages of the manufacturing process: the master cell bank (MCB), the end of production (EOP), and the bulk harvest. Creative Animodel offers infectivity assays in sensitive cell cultures and transmission electron microscopy (TEM) studies. Further testing is also available and only required if infectious retroviruses is not detected and no retrovirus or retrovirus-like particles have been observed by TEM. Retrovirus assays at Creative Animodel include:TME studiesXC plaque assays for ecotropic retrovirusesS+L focus assays for exnotropic retrovirusesCo-cultivation assaysPCR based reverse transcriptase (PBRT) assaysProduct enhanced reverse transcriptase (PERT) assays

Viral testing services at Creative Animodel are designed and performed by experienced experts. If you have any needs, please feel free to contact us.

Our customer service representatives are available 24 hours a day, from Monday to Sunday.

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45-1 Ramsey Road, Shirley, NY 11967, USA 1-631-614-7828 1-631-372-1052 Europe 44-207-097-1828

Creative Animodel

Creative Animodel is a world's leading commercial provider of custom animal model services. We offer top-quality services at unbeatable prices. Our customer service representatives are available 24 hours a day, from Monday to Sunday.

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