Biosafety Testing Services for Biologics
Viral vaccines and cell lines used to produce biologics must be tested to ensure they are free of adventitious agents (e.g., viruses). While methods such as PCR can detect specific viruses, a broad range in vivo screening assay can detect potential contamination caused by unspecified agents. Each lot of a biologic product intended for human use requires safety testing for extraneous toxins. Additionally, some products require determination of the tumorigenic properties of the cell substrate.
Our in vivo biosafety testing services is supported at sites in both the US and Ireland. Take a look at a video providing an overview of all services offered at the Ballina, Ireland facility.
Charles River’s in vivo biosafety testing services groups routinely performs the following assays and testing. Custom assay services are available upon request.
Antibody Production Assays
Mouse, rat, and hamster antibody production (MAP, RAP, and HAP) testing are immunologically based procedures to detect and identify murine viral contaminants in biological specimens by using highly susceptible natural hosts (i.e., mice, rats, or hamsters) and sensitive and specific serologic assays.
Inapparent Virus/Adventitious Agent Assay
Whether clients are producing a biologic or viral vaccine, we can perform adventitious agent testing to meet various regulatory requirements. Guinea pigs, young adult mice, suckling mice, and embryonated eggs can all be utilized to determine the viral status of a cell line or substrate. While this test does not identify a specific virus, it is a critical component in the viral safety testing profile.
Tumorigenicity Testing
All cells used for live viral vaccine production, including human epithelial cells, must undergo tumorigenicity testing. To meet multiple regulatory requirements, we offer 84-day and 120-day tumorigenicity tests in athymic nude mice.
Frequently Asked Questions (FAQs) About In Vivo Biosafety Testing Services
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What is tumorigenicity testing?
Tumorigenicity testing is the process where tumor cells are inoculated into animals to determine whether the cell substrate is capable of forming tumors. You should use immunocompromised animal models for this testing because they are more susceptible to form tumors. Charles River offers the animal model needed for this testing to be performed by our Biosafety testing services group.
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What are the regulatory guidelines for in vivo biosafety testing?
Guidelines for biosafety testing services are as follows:
- Guidance for Industry, Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indication (February 2010) – Antibody production test, Adventitious agent assay, Tumorigenicity testing
- European Pharmacopoeia 2.6.16 – Adventitious agent assay
- European Pharmacopoeia 5.2.3 – Tumorigenicity testing
- Points to Consider (PTC) in the Characterization of Cell Lines Used to Produce Biologicals as Recommended by the US FDA Center for Biologics Evaluation and Research (1993) – Antibody production test, adventitious agent assay, tumorigenicity testing
- International Conference on Harmonisation (ICH), Guidance for Industry Q5A (R1): Viral Safety of Biotechnology Products Derived from Cell Lines of Human or Animal Origin (1999) – Adventitious Agent Assay, Antibody Production Test
- Guidance for Industry, Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indication (February 2010) – Antibody production test, Adventitious agent assay, Tumorigenicity testing