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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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M Biotechnology

Magnetic Capture Hybridization (MCH)

A purification method based on sequence-specific hybridization of labeled nucleic acid probes with targeted regions of test article nucleic acids, followed by magnetic bead capture. (TR50)

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Mandrel

Specialized filling needles on certain BFS machines which also act to form the container. (TR77)

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Masking

A type of interference that may result in low endotoxin recovery.(TR82)

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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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Master Cell Bank (mCb)/Master Virus Bank (mVb)

A stock of cells or virus used to produce the Working Cell Bank or the Working Virus Bank. Cell/virus banking is used to enhance biological consistency. (TR47)

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Master Seed Stock

Reference culture of a microorganism derived from an authenticated source such as American Type Culture Collection (ATCC) and used to produce working seed lots. (TR51)

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Matrix Spike Control

An internal control in which an amplifiable amount of nucleic acid is added to a test article to determine inhibition of the PCR. This addition is usually performed pre-extraction and should provide a weak signal 100% of the time. Also known as “interference control”. (TR50)

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Measured Values

Those values where activity is confirmed by interpolation from a reference standard curve.(TR82)

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Metabolite

A substance that is either the result of metabolism or a requirement for a metabolic process. (TR70)

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Method Comparability

The demonstration of analytical method comparability (AMC) for method replacements. A study to demonstrate that a modification to an existing method either improves or does not significantly change the analytical procedure’s characteristics relative to the methods’ validation and intended use. (TR57)

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Microbial Count Determination

A test performed to quantify the number of microorganisms present in a sample of material. Standard microbial methods are utilized to estimate the number of colony forming units (CFU) per unit mass or volume. (TR28)

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Microbial Enumeration

Compendial test for microbial counts using the plate-count, membrane-filtration or most probable number methods described in USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumerations Tests. (TR67)

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Microbiological Examination Tests

The compendial tests for microbial enumeration and absence of specified microorganisms as found in USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumerations Tests and USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms. (TR67)

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Microbiological Identification

Biochemical characterization of isolated colonies to determine the isolate genus and, where feasible and appropriate, the species. (TR22)

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Microfiltration (MF)

Pressure-driven, membrane-based separation process in which particles and dissolved macromolecules (typically 0.1 &mum or larger) are retained. (TR15)

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Microorganism

A microbe; a free-living organism too small to be seen by the naked eye. (TR45) (TR26)

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Microorganism of Concern

A bacterium, yeast, or mold that, due to it prominence in product recalls, infection outbreaks, nosocomial infections, and the clinical literature, results in a multifactor risk assessment to determine whether the microorganism is objectionable if it is present in a specific nonsterile product. (TR67)

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Mollicutes

A class of bacteria which lack a cell wall. Mollicutes are small, typically about 0.1-0.5 &mum in size, and vary in form (trivial name: mycoplasma) (TR50)

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Monodispersed particles

Particles of uniform size in a dispersed phase. In the case of viruses, this term refers to free virus particles not agglomerated to other viruses or proteins in solution. (TR41)

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Most Probable Number (MPN) Method

A statistical method of estimating the number of viable organisms suspended in a liquid. (TR51)

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Multi-Use System (MUS)

An engineered process equipment solution for process management and unit operations designed for repeated use. (TR66)

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Mycoplasma Reduction Filter

A sterilizing grade filter that also provides a log reduction value (or a titer reduction value) for a specified test mycoplasma according to the PDA Mycoplasma Consensus Method. (TR75)