What is biosafety testing?
Biosafety testing is a series of assays to evaluate the potential biological risks of new biological products, including viral testing, microbial testing, cell and molecular testing, and analytic testing.
What does the ability to detect low viral concentrations in biopharmaceuticals depend on?
All testing suffers from the inherent limitation of quantitative virus assays, i.e., that the ability to detect low viral concentrations depends for statistical reasons on the size of the sample.
What is adventitious virus?
Adventitious agents are defined by the World Health Organization (WHO) as microorganisms that may have been unintentionally introduced into the manufacturing process of a biological medicinal product [5]: these include bacteria, fungi, mycoplasma/spiroplasma, mycobacteria, rickettsia, protozoa, parasites, transmissible …
What is a BSL 2 lab?
BSL-2 laboratories are used to study moderate-risk infectious agents or toxins that pose a moderate danger if accidentally inhaled, swallowed, or exposed to the skin. Design requirements for BSL-2 laboratories include hand washing sinks, eye washing stations, and doors that close and lock automatically.
Which is the most appropriate method for viral clearance?
Virus Clearance
- Solvent/detergent inactivation is a robust, well-established viral clearance method.
- Low pH inactivation is effective against enveloped viruses.
- Other methods, such as heat (pasteurization), microwave heating, irradiation and high-energy light are less commonly undertaken.
How do you detect viral contamination?
Viruses can be detected by using assays that look for evidence of infectivity in a living system (in-vitro or in-vivo assays), or for viral markers including the presence of the virus genome (e.g., polymerase chain reaction [PCR]-based methods), viral proteins (e.g., enzyme assays for reverse transcriptase in …
What is adventitious agent testing?
Adventitious agent tests are routinely used to assess safety and purity of cell banks and biologics. The methods used have ensured that very few products have reached the market with viral contaminants, and in the cases where they have, the contaminants have not posed a risk to human health.
What is the difference between BSL-1 and BSL-2 organisms?
BSL-2 laboratories maintain the same standard microbial practices as BSL-1 labs, but also includes enhanced measures due to the potential risk of the aforementioned microbes.
What is viral clearance testing?
Viral clearance studies involve deliberate spiking of viruses or TSE agents into process intermediates and then demonstrating their inactivation or removal during the subsequent processing steps. This is usually done on a scaled-down version – a laboratory version – of the selected process steps.
How do you get a viral clearance?
Virus Clearance
- Solvent/detergent inactivation is a robust, well-established viral clearance method.
- Low pH inactivation is effective against enveloped viruses.
- Other methods, such as heat (pasteurization), microwave heating, irradiation and high-energy light are less commonly undertaken.
Which of the following tests is used for the detection of viral antibodies?
Enzyme immunoassays (EIA or ELISA) for detection of virus and/or viral antigen.
What does BSL-3 mean?
Biosafety Level 3
Biosafety Level 3 (BSL-3) BSL-3 laboratories are used to study infectious agents or toxins that may be transmitted through the air and cause potentially lethal infections. Researchers perform all experiments in a biosafety cabinet. BSL-3 laboratories are designed to be easily decontaminated.