Adventitious Agents / Virology Testing

When using cell lines for production of a biotechnology product or biological, adventitious agents are a major concern and In Vitro testing is required according to the ICH guidelines. We perform in vitro assays designed to detect adventitious viruses in cell banks, virus seed stock, raw materials and final products, including:

• In-vitro adventitious virus assay
• Porcine and bovine adventitious virus assay
• A range of assays addressing specific contamination risks also is available

Contact us to speak to our experts to discuss your in vitro testing requirements.

There is a wide range of Virology testing service available to ensure production of biologicals is free from contamination, including:

Virology Testing (adventitious virus)
We perform a series of biosafety assays designed to detect species specific adventitious viruses in master cell banks,  working cell banks,  virus seed stock, raw materials, unprocessed bulk and final products.

Each assay method is fully validated in accordance with ICH Q2 (R1) guidelines. Assays are available for human viruses, bovine viruses, porcine viruses, simian viruses, canine, murine and many more. Development and validation services also are available for emerging viruses.

Our virology testing services provide assurance of freedom from adventitious viruses.

In vitro assays - Virology Testing

• In vitro detection of endogenous and adventitious agents
• In vitro assays for presence of bovine and porcine as described in the 9 CFR
• Custom assays based on your virology testing needs

Rodent Virus Testing

• Mouse antibody production test (MAP)
• Hamster antibody production test (HAP)
• Rodent antibody production test (RAP)
• Custom assays based on your virology testing needs

Retrovirus Testing

• Co-cultivation assays (murine, ecotropic, amphotropic and rodent)
• PCR/RT-PCR detection of endogenous and adventitious agents Direct and extended XC plaque assay
• Retrovirus assays, including direct and extended S+L- focus assay (mink, feline)
• Amplification in Mus Dunni cells
• Transmission Electron Microscopy (TEM)

Quantitative PCR Testing for the Detection of Adventitious Virus

Our expert team performs quantitative PCR tests designed to detect adventitious and endogenous viruses in cell banks, virus seed stock, raw materials and final products.  We have a variety of assays available globally for:

• human viruses
• respiratory viruses
• porcine viruses
• bovine viruses
• simian viruses
• canine viruses
• murine and many more specific target PCRs.

Our dedicated and experienced virology team is available to provide guidance in protocol design for the most appropriate collection, preparation and evaluation of biologic samples to ensure sample integrity for PCR detection of adventitious virus.

Retrovirus Testing Services

Retroviruses can integrate into the host genome making them difficult to detect by normal methods. Retroviruses may also remain later in the cell genome, and therefore require specific methods for detection.

To address this, we provide a wide range of retrovirus detection testing services including:

• XC plaque assay
• S+L- focus assay
• PERT
• PCR/RT-PCR
• Transmission electron microscopy (TEM)
• Co-cultivation assays (murine, ecotropic, amphotropic and rodent)

Contact an expert about your Retrovirus testing needs.

Co-cultivation Assays for Retroviruses

Co-cultivation of production cells at the limit of the in vitro age is an assay we offer to test for latent retroviruses for our clients. Essentially, your production cells are plated along with susceptible cell lines that exhibit stronger phenotypic CPE when the virus enters them. Thus, viruses that are expressed as non-infectious particles or exhibit low level of expression in production cells are detected.

Contact an expert about your retroviruses by co-cultivation testing needs.

Mouse Antibody Production Test

We perform in vivo assays designed to detect adventitious and endogenous viruses in cell banks, virus seed stock, raw materials and final products.

A major concern when using mammalian cell lines for production of a biotechnology product or biological is the risk of contamination by endogenous and adventitious viruses, which can occur during the manufacturing process. Such contamination could have serious clinical consequences detrimental to the patient. Our in vivo virus detection services are available to ensure the absence of human and animal adventitious viruses in your biologicals.

In vivo testing services for viral contamination includes:

• Mouse antibody production (MAP) test
• Hamster antibody production (HAP) test
• Rat antibody production (RAP) test
• In vivo assays

Contact an expert about your vivo testing needs.

Electron Microscopy Services - Adventitious Agents

Electron microscopy services provide high-resolution images of viral or biological specimens at an ultrastructural level to detect the presence, absence, and quantitation of microbial or adventitious agents in biological fluids or in cell substrates. We provide GMP-compliant transmission electron microscopy (TEM) services for ultrastructural pathology and viral particle identification, tabulation, quantification and characterization in support of the FDA Points to Consider (PTC) documents.

We offer a variety of assay options for your electron microscopy needs including:

• Ultra-Thin Section Electron Microscopy
• Virus Particle Counts
• Virus Characterization
• Negative Stain
• Immuno-electron microscopy
• Bioprocess Validation

For more information on Electron Microscopy, visit here.

Contact an expert about your Electron Microscopy needs.