Pharmaceutical Drug Manufacturers

MAb
Monoclonal Antibody)

Machine Welding
Welding with equipment that performs the welding operation under the constant observation and control of a welding operator. The equipment may or may not perform the loading and unloading of the works.

Machine Lines/Process Lines
Surface topography created from machining or honing/polishing lines will normally run parallel but bisecting (perpendicular) lines may occur when the honing stone mandrel is removed from the work piece.

Macromolecules
Molecules whose molecular weights are greater than about 5,000 Daltons.

Macroparticle
Particle with an equivalent diameter greater than 5 µm. ISO/FDIS 14644-1

Macrophage
A phagocytic cell of the immune system found in blood and connective tissue and involved in removing debris after injury.

Macrorestriction Map
Map depicting the order of and distance between sites at which restriction enzymes cleave chromosomes.

Macroreticular Resin
An ion exchange resin with a reticular porous matrix that makes it effective for removing colloids and bacteria from process streams, as well as dissolved anions. It is especially useful for preventing colloidal and organic fouling of mixed-bed resins and premature clogging of final filters.

Maintainability
Ease with which maintenance can be performed.

Makeup Air
External air introduced to the air handling system for ventilation and pressurization.

Manual Welding
Welding in which the entire operation is performed and controlled completely by hand.

Manufacture
All operations of receipt of materials, production, packaging, repackaging, labelling, relabelling, quality control, release, storage and distribution of APIs and the related controls.

Manufacturer
The party responsible for the quality of the drug product.

Manufacturing Process
All manufacturing and storage steps in the creation of the finished product from the weighing of components through the storing, packaging, and labeling of the finished product, including, but not limited to, the following: Mixing, granulating, milling, molding, formulating, lyophilizing, tableting, encapsulating, coating, sterilizing, and filling.

Manufacturing Process (Biotechnology)
The basic processes for rDNA fermentation and purification normally include the following steps:

1. Inoculum Preparation: The aim is to develop for the production stage fermentation a pure inoculum in sufficient volume and in the fast-growing (logarithmic) phases so that a high population density is obtained. This is accomplished through a seed fermentation train.

2. The Medium: This is designed to provide the microorganism with all the nutrients it requires. Provision is usually made to add nutrients during fermentation.

3. Oxygen Supply: An adequate supply of oxygen is required. As oxygen is only slightly soluble in water, a number of methods are used to make oxygen more readily available to the microorganisms in the broth, including sparging, mechanical agitators, and dispersion baffles in the fermenter tank.

4. Temperature Control: Heat is generated both by the metabolism of nutrients and by the power dissipated in stirring and has to be removed by controlled cooling. Tank jackets or internal coils are used to control temperature.

5. Antifoam Agents: Microbiological systems that are vigorously stirred and aerated usually produce foam. Excessive foam cannot be tolerated and so provisions have to be made for adding antifoam agents.

6. Harvesting: This is the removal of the cells from the broth. This can be accomplished by cross-flow filtration or centrifugation.

7. Cell Lysis: With E. coli fermentations, the product protein is contained within the cell in the form of an inclusion body. High-pressure homogenizers are often used to chop up the E. coli bacteria into fine fragments, liberating the inclusion bodies for further processing.

8. Purification: This is the separation of the desired product from the other constituents in the harvested broth. Various processes including refolding, ultrafiltration/diafiltration, centrifugation, and chromatographic columns are employed to purify the product.

Mapping

Marker
An identifiable physical location on a chromosome (e.g., restriction enzyme cutting site, gene) whose inheritance can be monitored. Markers can be expressed regions of DNA (genes) or some segment of DNA with no known coding function but whose pattern of inheritance can be determined.

Material
A general term used to denote raw materials (starting materials, reagents, process aids, solvents) intermediates, APIs (Active Pharmaceutical Ingredients) and packaging and labelling materials.

Material Containment
The method to incorporate suitable measures into design procedures and operational practices for the containment of materials that can harm personnel and the workplace environment, and minimize potential for cross contamination and housekeeping concerns in the fine chemical, bulk pharmaceutical and pharmaceutical industries. Solids and/or liquids are normally most hazardous in the form of powders and have been divided into the following three categories:

1. Biologically Hazardous additives are compounds that when contacting a living cell, will alter, endanger, or damage the cell in some shape or form. These should be treated as requiring total containment.

2. Chemically Hazardous additives are compounds that when coming into contact with an oxidant, will cause harm to its surroundings due to reaction and/or oxidation. These products usually require containment and/or blanketing with an inert gas.

3. General Intermediates are compounds that are neither biologically nor chemically hazardous additives but they will cause a housekeeping problem. They usually require dusting prevention.

Maximum Cr/Fe Ratio
The maximum ratio of chromium to iron and the depth at which it occurs are the most direct measures of the chromium enrichment in a material oxide layer. Typical ratios are about 1.5 or greater for well-electropolished 316L stainless steel. The depth at which the maximum Cr/Fe ratio is found varies but is usually about one-half the oxide thickness.

Maximum Depth of Enrichment
In stainless steel the chromium enrichment layer comprises all depths at which the chromium concentration is greater than the iron concentration. For well electropolished 316L stainless steel, the maximum depth of this layer is typically 20 to 25 angstroms (Å). Chromium Enrichment Layer Thickness)

Maximum Working Pressure
The pressure at which the system is capable of operating for a sustained period.

Maximum Working Temperature The maximum temperature at which the system may operate for a sustained period. The maximum working temperature should relate to the maximum working pressure and the fluids involved.

Mb


Mean Kinetic Temperature (MKT)
The single calculated temperature at which the degradation of an article would be equivalent to the actual degradation that results from actual temperature fluctuations during the storage period. It is not a simple arithmetical mean. The MKT is calculated from average storage temperatures recorded over a one-year period, with a minimum of 12 equally spaced storage temperatures being recorded.

Mechanical Code
Uniform Mechanical Code™)

Mechanical Completion
The point in a project at which all equipment and materials have been installed, but not commissioned (started-up).

Media (plural of medium)
Substances used to provide sterile nutrients to the fermentation or cell growth process supporting the growth of the live microorganisms. Media may be liquid (broth) or solid, and generally include sucrose or glucose as a carbon source, various minerals, a nitrogen source, and selected growth factors.

Media Prep
The act of preparing nutrient media for cell culture or fermentation.

Medical Devices
Any health care product that does not achieve its principal intended purposes by chemical action in or on the body or by being metabolized. The term "devices" also includes components, parts, or accessories of medical devices, diagnostic aids such as reagents, antibiotic sensitivity disks, and test kits for in vitro diagnosis of diseases and other conditions. There are three classes of medical devices:

1. Class I, General Controls (registration of manufacturers, recordkeeping and labeling requirements, compliance with GMPs).

2. Class II, Special Controls (including performance standards, posmarket surveillance, and patient registries).

3. Class III, Premarket Approval (implanted and life supporting or life sustaining devices).

Medicinal Product
Any substance or combination of substances presented for treating or preventing disease in human beings or animals. Any substance or combination of substances that may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product.

Medium (filter)
The material from which a filter is constructed.

Megabase (Mb)
Unit of length for DNA fragments equal to 1 million nucleotides and roughly equal to 1Centimorgan (cM)

Megohm-cm/B>
A measure of ionic purity in water. (also see: Resistivity)

Meiosis
The process of two consecutive cell divisions in the diploid progenitors of sex cells. Meiosis results in four rather than two daughter cells, each with a haploid set of chromosomes.

Melanoma
A cancer that begins in skin cells called melanocytes and spreads to internal organs.

Membrane
A barrier, usually thin, that only permits the passage of particles of a certain size or special nature. Filtration membranes are thin polymer films that are permeable to water and other fluids:

1. Microporous membrane filters have measurable pore structures that physically remove particles or microorganisms larger than pore size.

2. Ultrafiltration membranes (sometimes called molecular sieves) also remove molecules larger than a specified molecular weight.

3. Reverse osmosis membranes are permeable to water molecules and very little else, rejecting even dissolved ions and endotoxins in water.

Meristem
The growing point or area of rapidly dividing cells at the tip of a stem, root, or branch.

Mesophile An organism that grows best in the temperature range of 20°C to 50°C (68°F to 122°F).

Messenger RNA (mRNA)
RNA that serves as a template for protein synthesis.

Metabolism
The sum of the physical and chemical changes in living cells by which energy is provided for vital processes and growth in cell mass.

Metabolite
Any of the various organic compounds produced by metabolism.

Metadata
Electronic records that include processing parameters and audit trail logs. Metadata allows reviewers to replay the original result, or reconstruct a final report from raw data. In chromatography, metadata include integration parameters and calibration tables. An example of metadata can be in long division "1,000 ÷ 5" would be the raw data, the work you had to show on your paper in fourth grade math class would be the metadata, and "200" would be your result.

Metaphase
A stage in mitosis or meiosis during which the chromosomes are aligned along the equatorial plane of the cell.

Metastases
The plural of metastasis.

Metastasis
In cancer, it is the appearance of neoplasms in parts of the body remote from the seat of the primary tumor. It also applies to the transportation of bacteria from one part of the body to another through the blood streams (hematogenous metastasis) or through lymph channels (lymphogenous metastasis).

Methods Validation
Establishing, through documented evidence, a high degree of assurance that an analytical method will consistently yield results that accurately reflect the quality characteristics of the product tested.

Methyl Cellulose
A common viscosity-increasing agent used in ophthalmics (also see: Ophthalmic) preparations. It is inversely soluble with temperature.

Mho
Unit of measurement for conductance; the reciprocal of ohm (resistance).

Microbe
A microscopic one-celled organism, animal or vegetable, a microorganism.

Microbiology
The study of microscopic life such as bacteria and viruses.

Microencapsulated
Surrounded by a thin, protective layer of biodegradable substance referred to as microsphere.

Microinch
A unit of length equal to one millionth of an inch (0.000001 inches).

Micron or Micrometer
A unit of length equal to one millionth of a meter (µm) or thousandth of a millimeter (25µm are approximately 0.001 inch.). Bacteria range in size from 0.5µm to 20µm.

Microorganism
A microbe - A microscopic plant or animal, such as a bacterium, protozoan, yeast, virus, or algae.

Microhmo
A measure of conductance equal to one millionth of a mho.

MIG (Metal Inert Gas)


Milliequivalent
To simplify the calculation of ion exchange resin capacity, total dissolved ion concentrations are usually converted into equivalent concentrations of calcium carbonate, the most common source of dissolved ions in water. Resin capacity is normally given in ppm as CaCO3, or in grains per gallon as CaCO3 (7,000 grains = 1 pound). However, it may also be given as milliequivalents per liter (meq/L). Since calcium carbonate has a molecular weight of 100 and an equivalent weight of 50 (because calcium has a valence of two) ppm as CaCO3 can be converted to meq/L by dividing by 50. Thus, 1 ppm of CaCO3 = 0.02 meg/L.

Minienvironment
The actual localized control space limited by a defined enclosure that separates or isolates the inside from the outside environment, such that the transfer of potential contamination from one side to the other is minimized or completely eliminated, depending on the design. Minienvironments are not always isolators. ISO 14644-4. (

Mitosis
The process of nuclear division in cells that produces daughter cells that are genetically identical to each other and to the parent cell.

Mixed Airflow Room
Room which is supplied of air by conventional "turbulent" means, such as a diffuser or terminal HEPA filter but also includes an unidirectional flow zone (such as a hood over a critical area). Total air changes of the room are greatly enhanced by the operation of the hood.

Mixed-Bed Ion Exchange
Mixing both anion and cation resins in the same deionizer results in higher efficiency, but lower capacity, than separate-bed deionizers.

MoAb


Moiety
A part or portion of a molecule, generally complex, having a characteristic chemical or pharmacological property.

Moist Air
A binary mixture of dry air and water vapor. Each component behaves as if the other is not present and each occupies the complete volume of the mixture. (also see: Dry Air)

Molds
Filamentous fungi that have a mycelial structure. (also see: FungiMycelium

Mole
One gram molecular weight of a compound.

Molecule
A group of atoms arranged to interact in a particular way; one molecule of any substance is the smallest physical unit of that particular substance.

Molecular Genetics
Deals with the study of the nature and biochemistry of genetic material. Includes the technologies of genetic engineering.

Molecular Weight
The weight of a molecule that may be calculated as the sum of the atomic weights of its constituent atoms. Atomic weight is the weight of an element in relation to some element taken as the standard, usually oxygen (16) or carbon (12).

Monoclonal Antibody (Mab or MoAb)
Antibodies derived from a single source or clone of cells that recognize only one type of antigen. They are produced from hybridomas formed by the hybridization of two cells: a single antibody-producing cell and a cell that can be grown indefinitely in culture (also see: Cell Fusion, Clone, Hybridoma). Monoclonal antibodies have found markets in diagnostic kits and show potential for use in drugs and industrial purification processes.

Monomer
The basic subunit from which, by repetition of a single reaction, polymers are made. For example, amino acids (monomers) condense to yield polypeptides or proteins (polymers).

Monosaccharides
The building blocks of carbohydrates, hence known as "simple sugar". They are classified by the number of carbon atoms in the molecule, pentoses have five and hexoses six.

Mother Liquor
The residual liquid that remains after the crystallization or isolation processes. A mother liquor may contain unrecovered products (i.e., unreacted starting materials, intermediates, levels of the API and/or impurities). It may be used for further processing.

mRNA


MSDS (Material Safety Data Sheet)
Document describing the chemical and physical properties of a substance as related to its safe handling and storage. The substance manufacturer originates it.

Multicellular
Referring to organisms composed of more than one cell - often billions of them, arranged in various organs, tissues, and systems.

Multifactorial or Multigenic Disorder


Multiplexing
A sequencing approach that uses several pooled samples simultaneously, greatly increasing sequencing speed.

Multi-use Equipment
Equipment used to process more than one product.

Murine
Relating to a member of the rodent family Muridae, including rats and mice; such as murine monoclonal antibodies derived from mice.

Mutagen
An agent that induces cellular DNA to undergo mutation (e.g. X-rays, mustard gas radiation).

Mutagenesis
The induction of mutation in the genetic material of an organism; researchers may use physical or chemical means to cause mutations that improve the production of capabilities of organisms.

Mutant
The altered cell resulting from mutation of the original wild type or any subsequent alteration.

Mutation
An abrupt change of genotype involving either the structure or number of complete chromosomes or, more commonly, a change in the structure of a single gene so that its function is altered or lost. Certain chemicals called mutagens can induce it.

Mycelium
The mat or complex group of protoplasmic units, or the entangled mass of tubelike or filamentous structures, i.e., hyphae, that represents the "body" of plant forms classified as Eumycetes (including Phycomycetes, Ascomycetes, Deuteromycetes (Fungi Imperfectii), and Basidiomycetes).

Mycobacterium
A genus of the family Mycobacteriaceae containing slender, aerobic, usually acid fast, Gram positive, rod-shaped organisms of various forms, club shaped, swollen, but seldom branched or with filaments; it includes many species which were formerly and are still called bacilli, such as the pathogens of tuberculosis and leprosy.

Mycoplasma
The smallest, free-living organism with a size range from 1.25µm to 0.5µm. Pleomorphic (many shapes) because of a lack of a cell wall. Cannot be quantitatively removed by 0.2µm filtration

Myeloma
A malignant human plasma cell that can synthesize excessive amounts of whole antibody or single immunoglobulin chains.

Pharmaceutical Abbreviations | Abbreviations in product information leaflets and literature
Acronyms | Glossary of Terms | Abbreviations used in the British Pharmaceutical