Host Cells/Parental Cells
A non-transfected cell substrate that is generally well-characterized and banked. It can be manipulated to generate a cell substrate for production of a biological medicinal product. (TR83)
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Cell Line
Type of cell population with defined characteristics that originates by serial subculture of a primary cell population that can be banked. (TR83)
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Animal-Derived Raw Materials (Tertiary)
Sourced from synthetic components but includes animal-derived components used during the manufacture of the raw material that do not come in direct contact with the raw material, for example, polymers or elastomers used in process equipment or plumbing that may contain or may have been exposed to animal-sourced materials such as stearates or slip agents. (TR83)
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Animal-Derived Raw Materials (Secondary)
Non-animal in origin but may be derived from processes that include materials from animal components that come in direct contact with the raw material, for example, a recombinant protein produced in an E. coli fermentation that uses fermentation medium containing tryptone, or a recombinant protein expressed in plants that are exposed to bovine manure fertilizer. (TR83)
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Animal-Derived Raw Materials (Primary)
Contains in the final raw material or uses in the manufacturing process of the final raw material, any raw material derived directly from bovine or other animal tissues, for example, bovine serum, porcine-derived trypsin, and animal-tissue-derived hydrolysates. (TR83)
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Virus
A simple, potentially pathogenic organism composed of a single type of nucleic acid (DNA or RNA) encased in a protein shell (called a capsid) and, in some cases, a lipid membrane (called an envelope). Viruses are incapable of independent replication and therefore must infect a host cell in order to propagate. (TR41)
Obligate, intercellular, replicating, infectious agents that are potentially pathogenic, possessing only a single type of nucleic acid (either RNA or DNA). They use the host cells for propagation as they are unable to grow independently, for example by binary fission, and multiplying their genomic material. (TR47) (TR83)
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Viral Removal
Physical separation of virus particles from the intended product. (TR47) (TR83)
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Viral Inactivation
Reduction of virus infectivity caused by chemical or physical modification. (TR41) (TR83)
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Raw Materials
Starting materials, reagents, and solvents used in the production of intermediates or APIs/drug substance. (TR54-4) (TR83)
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Master Cell Bank (MCB)
The MCB represents a collection of cells of uniform composition derived from a single source prepared under defined culture conditions. (TR 54-4)
The MCB represents a collection of cells of uniform composition derived from a single source prepared under defined culture conditions, aliquoted into multiple vials, cryopreserved and stored in the vapor phase of liquid nitrogen. (TR 83)
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Endogenous Virus
A virus that pre-exists in the genome of the cell substrate. (TR71)
A virus that integrates into the genome of the cell substrate. (TR83)
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Contaminant
Any adventitiously or externally introduced material(s) (e.g., chemical, biochemical, or microbial species) not intended to be part of the process. (TR14) (TR15) (TR70)
An undesired impurity of a chemical or microbiological nature that is introduced into a raw material, intermediate, or API (drug substance) during manufacture. (TR14) (TR15)
Any adventitiously introduced materials (e.g., chemical, biochemical, or microbial species) not intended to be part of the manufacturing process of the drug substance or drug product. (TR69) (TR74)
Any adventitiously introduced material (e.g., chemical, biochemical) or microorganisms including viruses not intended to be included in the manufacturing process of the drug substance or drug product. (TR83)
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Cell Substrate
The host cells that are used to propagate or detect viruses. (TR 47)
Cells used for the manufacture of a biological medicinal product. (TR 71) (TR 83)
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