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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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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)

Source: TR 83: Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response

Virus Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Quality Risk Management/QRM Technology Transfer Vaccines

Biomethylation

The enzyme chlorophenol o-methyltransferase responsible for fungal methylation has been isolated in cell-free extracts. Biomethylation, in this context, may be seen as a detoxification mechanism, although it plays a role in the production of mycotoxins by secondary metabolism. Slightly xerophilic fungi frequently associated halophenol biomethylation include Trichoderma longibrachiatum, Trichoderma virgatum, Aspergillus sydowii, and Penicillium islandicum. (TR55)

Source: TR 55: TBA/TCA Detection Mitigation

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

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

Adverse Event (AE) Report

An AE report is a communication to the U.S. FDA of an undesirable sign or symptom associated with use of a drug as required and detailed by 21 CFR 314.80. These reports are logged into the U.S. FDA’s Adverse Event Reporting System (AERS). Drug manufacturers are required to report adverse event information to FDA. These reports may also may be voluntarily submitted to the FDA directly by healthcare professionals or the general public at Med Watch. The reports are reviewed, safety issues are monitored, and data are periodically analyzed and assessed by the Center for Drug Evaluation and Research (CDER). (TR55)

Source: TR 55: TBA/TCA Detection Mitigation

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