PDA Technical Glossary

PDA Technical Reports are highly valued membership benefits because they offer expert guidance and opinions on important scientific and regulatory topics and are used as essential references by industry and regulatory authorities around the world. These reports include terms which explain the material and enhance the reader’s understanding.

The database presented here includes the glossary terms from all current technical reports. The database is searchable by keyword, topic, or by technical report. Each definition provided includes a link to the source technical report within the  PDA Technical Report Portal.

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Viral Removal
Physical separation of virus particles from the intended product. (TR47) (TR83)

Source: TR 47: Virus Spikes/Virus Clearance

Virus Biotechnology Filtration Sterile Processing

TCld50 Assay
Quantal assays for determining the titer of a virus. The 50% tissue culture infective does (TCID50) is the dilution of virus that results in the infection of 50% of cell cultures that have been infected with the same dilution of the virus sample. (TR47)

Source: TR 47: Virus Spikes/Virus Clearance

Virus Biotechnology Microbiology Validation Quality Risk Management/QRM Sterile Processing

Polymerase Chain Reaction (PCR)
A technique widely used in molecular biology in which a DNA polymerase is used to amplify a piece of DNA by in vitro enzymatic replication. As PCR progresses, the DNA thus generated is itself used as a template for replication. This sets in motion a chain reaction in which the DNA template is exponentially amplified. This technique may be used to quantify virus. (TR41) (TR47)

Source: TR 41: Virus Filtration

Virus Biotechnology Manufacturing Microbiology Quality Risk Management/QRM Sterile Processing Technology Transfer

Plaque Forming Unit (PFU)
A measure of virus infectively based on formation of a region, or “plaque” of lysed cells within a monolayer culture caused by viruses that kill and disrupt their host cell. The number of plaques is directly correlated to the number of infectious virus particles. (TR47)

Source: TR 47: Virus Spikes/Virus Clearance

Virus Biotechnology Manufacturing Microbiology Validation Sterile Processing

Hemagglutination
A clumping together or agglutination of red blood cells. In the context of this Technical Report hemagglutination indicates presence of virus that binds to erythrocytes. (TR47) The clumping of red blood cells by binding to virus particles. The hemagglutination reaction is used in cell-based in vitro assays as an end point for virus detection. (TR71)

Source: TR 47: Virus Spikes/Virus Clearance

Virus Biotechnology Microbiology Sterile Processing

Hemadsorption
Adherence of red blood cells to virus-specific antigens on the surface of infected cells. In cellbased in vitro assays the reaction is used as an end point for virus detection. (TR47) (TR71)

Source: TR 47: Virus Spikes/Virus Clearance

Virus Biotechnology Microbiology Sterile Processing

Focus Forming Unit (FFU)
A measure of virus infectively based on formation of a region or “focus”, of infected cells within a monolayer culture that is caused by viruses that do not kill their host, but rather transform them. The number of foci is directly correlated to the number of infectious virus particles. (TR47)

Source: TR 47: Virus Spikes/Virus Clearance

Virus Biotechnology Manufacturing Microbiology Validation Sterile Processing

Cytopathic Virus
Viruses where infection of cells results in microscopically visible degeneration of the cells or other morphological changes. (TR47)

Source: TR 47: Virus Spikes/Virus Clearance

Virus Biotechnology GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing Vaccines

Cytopathic Effect (CPe)
Morphological changes induced by viruses in infected cells in invitro culture. They are usually localized around a site of initial infection and vary in appearance based on the virus and the cultured cell. (TR47)

Source: TR 47: Virus Spikes/Virus Clearance

Virus Biotechnology GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing Vaccines

Bioburden
The total number of microorganisms per unit of material prior to sterilization. (TR13) Total number of viable microorganisms on or in a health care product prior to sterilization. (TR22)(TR61)(TR62) A population of viable microorganisms in a fluid prior to sterilizing filtration. (TR26) A measure of the contaminating organisms found in or on a given amount of material before it undergoes a sterilization process. (TR45) (TR70) The number of detectable microorganisms (bacteria and fungi) with which an object is contaminated. It is measured in CFU (colony forming units). (TR47) The number of viable, contaminating microorganisms present on a product immediately prior to decontamination. (TR51) Viable microbial contaminants associated with personnel manufacturing environments (air and surfaces), equipment, product packaging, raw materials (including water), in-process materials, and finished products. (TR 67) (TR 69)

Source: TR 13: Environmental Monitoring

Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing

Aggregation
Clumping of proteins, viruses, or bacteria that may arise from several mechanisms and may be classified in numerous ways, including soluble/insoluble, covalent/noncovalent, reversible/irreversible, and native/denatured. (TR47)

Source: TR 47: Virus Spikes/Virus Clearance

Virus Biotechnology Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Inspections Microbiology Quality Risk Management/QRM Sterile Processing Vaccines