Glossary

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Specific proteins on the capsid of a virus that can act as inducers of antibody formation.

(ICH Q5A (R1)) Elimination of target virus by removal of viral particles or inactivation of viral infectivity.

Removal and/or inactivation of viruses from a biopharmaceutical product. Sometimes methods are a combination or removal and inactivation.

Process step which separates a given class of virus, if any are present, from the desired product. A clearance factor may be estimated by performing scale-down experiments using a model virus, to determine process capability.

The act of inactivating viral activity/infectivity (differs from removal). Use of low pH is a common method for viral inactivation.

Process step, which inactivates the activity of a given class of virus, in order to provide assurance of safety. An inactivation factor may be estimated by performing scale-down experiments using a model virus, to determine process capability.

Vaccines consisting of live viruses rather than dead ones or separated parts of viruses. However, as the virus itself cannot be used, because that would simply give the patient the disease, the virus is genetically engineered so that it elicits the immune response to the viral pathogen without causing the disease itself.Two genetic engineering methods can be used. The first is to make the disease virus harmless, but still able to replicate in cultured animal cells. This is similar to producing an ‘attenuated’ virus, i.e., one which has been grown in the laboratory until it loses its ability to cause disease. However, the genetic engineering route seeks to make sure that the attenuated virus has no chance of mutating back to a wild type, pathogenic virus, by deleting whole genes or replacing key regions of genes with completely different genetic material.The second approach is to clone the gene for a protein from the pathogenic virus into another, harmless virus, so that the result ‘looks’ like the pathogenic virus but does not cause disease.

A plastic material that has not been subjected to use or processing other than that required for its initial manufacture. It can be in the form of pellets, granules, powder, floc, or liquid.

An infectious virus particle. A plant pathogen that consists of a naked RNA molecule of approximately 250-350 nucleotides, whose extensive base pairing results in a nearly correct double helix.

An infectious entity similar to a virus but smaller, consisting only of a strand of nucleic acid without the protein coat characteristic of a virus.

Study of viruses.

Identifies Digital Equipment Corporation's VAX family of computers, ranging from a desktop workstation to a large scale cluster of multiprocessors supporting thousands of simultaneous users.

Instrument to separate the particle sizing by inertial force to collide with the hypothetical (virtual) surface.NOTE: Large particles pass through the surface into a stagnant volume and small particles deflected with the bulk of the original airflow.

Digital Equipment Corporation's multiprocessing, interactive operating system for the VAX computers.

An agent that destroys or inactivates viruses.

The degree of ability of an organism to cause disease. The relative infectiousness of a bacterium or virus, or its ability to overcome the resistance of the host metabolism.

A program which secretly alters other programs to include a copy of itself, and executes when the host program is executed. The execution of a virus program compromises a computer system by performing unwanted or unintended functions which may be destructive.

(ICH Q5A (R1)) Intracellularly replicating infectious agents that are potentially pathogenic, possessing only a single type of nucleic acid (either RNA or DNA), are unable to grow and undergo binary fission, and multiply in the form of their genetic material.

A noncellular organism and an intercellular parasite, consisting of nucleic acid (DNA or RNA) in an outer coat of protein. Viruses can live and reproduce only in susceptible host cells; host cells can be bacteria, plant, or animal. The host cell’s synthesis is often inhibited by the infecting virus, which may or may not result in disease (more than 200 viruses are known to produce human disease). An individual virus particle is called a virion, and virions vary in structure, complexity, and size (ranging from 20-25 nm or less to 2,000 nm or more). Six classes of virus are defined by whether they are single or double stranded, DNA or RNA, or positive or negative.

Generic term for all the various types of malicious code that has been designed to breach a company’s security requirements/measures.

A “genetic parasite”, which attaches a host cell and alters its genetic program so that it produces viruses. Many viruses are completely harmless, while others are lethal. Viruses are so small that they can be seen only under an electron microscope with ten-thousandthfold magnification.

(ICH Q5A (R1)) Physical separation of virus particles from the intended product.

(ICH Q5A (R1)) Structures visible by electron microscopy which morphologically appear to be related to known viruses.

Particles that resemble retroviruses, yet lack infectivity, and usually are found in established lines of mammalian cells. Cell bank characterization seeks to determine whether viral activity is present, as a means of assessing risk. Not present in non-mammalian cells or cell lines.