How is virus inactivation done?

The inactivation of virus contaminants can be achieved by subjecting the bioprocess fluid to conditions that denature the virus protein but not the active ingredient. In the production of biologic therapies, the two most commonly employed inactivation methods are the use of low pH or addition of detergents.

What is used to inactivate viruses?

Today, there are six licensed viral vaccines that are inactivated with either formaldehyde or BPL. Formaldehyde is used for the inactivation of Poliovirus (PV), Hepatitis A Virus (HAV), Japanese Encephalitis Virus (JEV), and Tick Borne Encephalitis Virus (TBEV) to generate vaccines.

How do you inactivate enveloped viruses?

Deactivation with detergents is more common in blood plasma processing, whereas low pH inactivation is more frequently applied to mAb processing. In the latter case, a low pH hold of 1 hour at a pH of 3.5 is typically applied and is effective against enveloped viruses.

What are the techniques used in detecting virus?

These techniques are chemical/physical measures of virus quantification and they include serologic assays, polymerase chain reaction (PCR), and hemagglutination assays (HA). Negative staining EM can also be used as a chemical/physical assay to detect and count virus particles.

Why do we purify virus?

Purified virus is required for the production of antibodies, physical, biochemical and molecular characterization of virus isolates. Purification of virus involves several steps such as propagation of the virus in the host, extraction of sap, clarification, concentration and further purification.

What is viral filtration?

Virus filtration uses a membrane barrier to retain virus particles. It is a size-based removal method which uses a specifically designed polymeric membrane to retain virus particles on the surface and within the pores of the membrane.

What is inactivate?

to make inactive
: to make inactive: as. a : to destroy certain biological activities of inactivate the complement of normal serum by heat. b : to cause (as an infectious agent) to lose disease-producing capacity inactivate bacteria. Other Words from inactivate. inactivation \ (ˌ)in-​ˌak-​tə-​ˈvā-​shən \ noun.

What is the meaning of inactivated virus?

These vaccines have a weakened version of the live virus, to stop it from causing the disease but to still encourage the production of T cells. Inactivated vaccines are another form of vaccine, where the virus is inactivated during the process of making the vaccine.

What is the difference between an enveloped and non-enveloped virus?

Viruses can be divided into two main categories; enveloped viruses, which have a lipid membrane (envelope) that is derived from the host cell; and non-enveloped viruses, which lack a membrane.

How does low pH inactivation work?

Low pH inactivation is commonly used in monoclonal antibody purification processes to inactivate large enveloped viruses. Adjusting the pH to achieve this as part of a single-use biomanufacturing workflow usually requires manual manipulation of the product and vessel by a skilled operator.

How are viruses treated and prevented?

For most viral infections, treatments can only help with symptoms while you wait for your immune system to fight off the virus. Antibiotics do not work for viral infections. There are antiviral medicines to treat some viral infections. Vaccines can help prevent you from getting many viral diseases.

What is the most common method of viral identification?

PCR is one of the most widely used laboratory methods for detection of viral nucleic acids. PCR analysis can also be used to determine viral RNA, by adding an initial step in which the RNA is converted into DNA; know as reverse transcriptase PCR (RT-PCR).

What are the different methods of viral inactivation?

Multiple methods of viral inactivation are possible. The most common are: Low pH based methods – especially for biotherapeutic products like monoclonal antibodies (mAbs) Less frequently used viral inactivation methods include pasteurization, dry heat and vapor heat – in particular for blood or serum based products.

What are critical process parameters for viral inactivation?

Any viral inactivation method, low pH or surfactant, benefits from precise and simultaneous control of multiple Critical Process Parameters (CPPs); a capability which is required to effectively understand the process itself and the effect on Drug Substance (DS).

What happens to the virus during inactivation?

During inactivation, any virus present within the pooled and semi-purified therapeutic suspension is intentionally destroyed or abruptly rendered non-pathogenic, usually by altering the environment around the virus to cause irreversible disruption and denaturation of the viral structure.

What is the best way to inactivate a virus?

Solvent or detergent viral inactivation methods are commonly employed against enveloped viruses. Reagents used generally have negligible impact on the lability of the therapeutic protein or antibodies which are subject to the challenges of denaturation or deamidation possible with some low pH methods.