Virology testing services from SGS – confirm the absence of infectious virus contaminants in your drug products with our precise cell culture based assays.
As a manufacturer of biopharmaceutical products derived from cell lines of human or animal origin, you need to test your products throughout production to confirm the absence of contaminating infectious viruses. Our virology testing services provide you with validated in vitro adventitious virus and retrovirus assays to help you meet US and European guidelines.
Why choose virology testing services from SGS?
Our virology testing services include adventitious virus testing, retrovirus testing and in vitro cell based assays. We can help you:
- Gain effective virology testing for cell bank characterization, or characterization of products derived from cell lines – including human or rodent origin. We also provide testing for batch release, clinical trials or marketing release
- Detect viruses derived from animal products (for example from bovine or porcine origin)
- Screen virus vectors/vaccines for the presence of infectious contaminants
Leading virology testing from a world-class provider
As a world-leading provider of virology testing, we provide the experience, technical and regulatory expertise, and unique global network you need. As a result, we can design complex and customized assays to meet specific product requirements.
In vitro assays
We offer you 14 and 28 day in vitro assays using a customized combination of cell lines – such as MRC-5, Vero, CHO-K1, HeLa, HEK293, murine, etc. – for the characterization of products derived from rodent or human cell lines.
Indicator lines suitable for use in the testing of other products, or to extend the host range of the indicator panel, are also available.
Retrovirus assays
We offer you a range of infectivity assays, including:
- XC assays to detect infectious ecotropic murine leukemia virus (MLV)
- S+L- assays using feline or mink cell lines, to detect amphotropic or xenotropic MLV
- Mus dunni cells, with either immunofluorescence end-point or a PG4 cell end-point, for detection of ecotropic, amphotropic, xenotropic and mink cell focus-forming viruses
For non-murine retroviruses we offer you infectivity testing on appropriate indicator cells (selected for their susceptibility to different retrovirus types).
We also provide you with validated retrovirus infectivity assays for the detection of murine ecotropic, amphotropic, xenotropic and mink-cell focus forming viruses and co-cultivation assays to amplify viruses with a tropism for human cells.
To find out more about our virology testing services, contact us today.