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 assays||In Vitro assays|
|Mouse antibody production (MAP) testHamster antibody production (HAP) testRat antibody production (RAP) testSpecific assays for vaccine testing||14 and 18 day adventitious virus assaysPorcine and bovine adventitious virus assaysSpecies-specific viral PCR assaysCustomized assays addressing specific contamination risks|
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.