A l B l C l D l E l F l G l H l I l J l K l L l M l N l O l P l Q l R l S l T l U l V l W l X l Y l Z
A
- Acrolein:
- Raw material used in the synthesis of products for the perfumery, pharmacy and graphic arts markets, the application of which requires special safety equipment.
- Additives:
- chemicals which impart specific performances to fuels, lubricants, paints etc. into which they are introduced.
- Amino Acids:
- Small molecules produced by natural living organisms and is a compound unit “building blocks” of proteins.
- AMM (Marketing Authorization of drugs):
- the health regulatory authorities assign a registration number to any new drug, for its market authorization. This number may be found on the medicine packet.
- Anaerobic:
- Term which designates an organism that is able to grow without oxygen.
- ANR:
- National Research Agency (French research organisation funding) which provides companies with research grants.
- API:
- Active Pharmaceutical Ingredient
- AFSSAPS:
- French agency for the Sanitary Safety of Health-care products.
B
- Back-up:
- procedure for registering a second production site and thereby overcoming any issues at the main site.
- Batch:
- a unique quantity of product produced from a chemical step.
- Biologics:
- different terms are used (Biological products, biotechnology medicines or therapeutic proteins), and concern protein derived from a living source (human, animal or unicellular). Most biologics are complex mixtures that are not easily identified or characterized, and many are manufactured using biotechnology. Biological products often represent the cutting-edge of biomedical research and are sometimes the most effective way to prevent or treat a disease (i.e. monoclonal antibodies, recombinant proteins, enzymes, small peptides).
- Biotechnology:
- according to the OECD, is “The application of science and technology to living organisms, as well as parts, products and models thereof, to alter living or non-living materials for the production of knowledge, goods and service” or simply the industrial use of living organisms (or parts of living organisms) to produce foods, drugs, services...
- Blockbuster:
- drug where sales turnover represents more than 1 billion dollars.
- BPF (Bonnes Pratiques de Fabrication)/(Good Manufacturing Pratice):
- international production standard used in the pharmaceutical industry in accordance with a quality benchmark produced by the French National Drug Agency. BPF conditions must be met in order to be able to exploit pharmaceutical sites which are regularly audited by the sanitary authorities.
- Building block:
- Basic element to develop more complex molecules.
- Bulk API (Active Pharmaceutical Ingredient):
- industrial content of an active pharmaceutical ingredient*.
C
- cGMP (current Good Manufacturing Practices):
- production standard in accordance with prevailing US standards, as published by the Food and Drug Administration (FDA). These production methods are mandatory in order to be able to export a pharmaceutical active ingredient (or certain synthesis intermediates) to the USA. The FDA carries out inspections to make sure that factory productions comply with these rules.
- Chirality:
- property of non-surimposable entities (for example, the right hand and the left hand).
- Clinical development:
- set of medical investigations for defining the therapeutic activity of an active ingredient, the administration method, the doses to be taken, the side-effects…Full development of a drug generally lasts 10-14 years and affects an average of one molecule out of 10,000.
- Clinical trials:
- Each medicine is systematically tested on humans, they are voluntary ill or healthy people, in order to highlight or to verify the effects, to identify all undesirable effects, to study the absorption, distribution, metabolism, extraction in order to establish the efficiency and the security of use of the medicine in question.
- CMC (Chemistry, Manufacturing and Control):
- File in which the chemistry, process and control method of an active ingredient are described.
- Conducting polymers:
- generally organic polymers which may conduct electricity when submitted to an electric field.
- Cryogenic reaction:
- chemical reaction at temperatures below -80°C.
- CtP (Computer To Plate):
- technology for printing directly from the computerized tool onto heat sensitive plates without passing through the lithographic process. This requires special chemicals which react at specific wavelengths.
- Custom manufacturing:
- Products for the pharmaceutical or any other industry field whereby the synthesis is custom-made.
- Cytotoxic molecule:
- molecule which interferes with a biological process at a very low dose.
D
- Diborane chemistry:
- diborane, a boron derivative bearing hydrogen atoms, is used in specific reduction reactions.
- DRIRE (Direction Régionale de l’Industrie, de la Recherche et de l’Environnement):
- A French national organisation responsible for inspecting listed corporations. Every chemical plant is listed and therefore regularly audited by this organisation. They are also involved in drawing up district by-laws (arrêtés préfectoraux) to which factory operational conditions are subjected.
- Drug Master File (DMF):
- totality of technical and analytical data serving as the basis for the request for a market authorisation for a drug (see French market authorisation).
E
- EDQM:
- European Directorate for the Quality of Medecine.
- EHS :
- Environment, Health & Safety
- Electroceramic:
- a ceramic material with certain specific electrical properties (dielectric, semiconductor, conductor…).
- Electroluminescent polymers:
- types of conducting polymers which, when submitted to an electric field, conduct current and emit light.
- EMEA (European Medicinal Evaluation Agency):
- European agency which evaluates medicinal products, today known as the European Medicinal Agency.
- Enzyme:
- A class of protein that speeds up a chemical reaction in a living organism in nature. An enzyme acts as catalyst for specific chemical reactions, converting a specific set of reactants (called substrates) into specific products.
- Enzymatic catalysis:
- With the aim of increasing the speed of a reaction during a chemical synthesis, a chemical catalyser is used the most often possible. Metal, ion, complex or enzyme which interacts with other reactive molecules to accelerate their transformation and obtain products with the sought after reaction as quickly as possible. We talk therefore of an enzymatic reaction or biocatalysis when a reaction is catalysed by an enzyme.
- Enzymatic resolution:
- substance conversion reaction, using the properties of an enzyme.
- Ex-vivo:
- experiments carried out on living human or animal cells, outside the body of the patient or the animal.
F
- FDA (Food and Drug Administration):
- US organiz that allows the authorization for launching a new drug.
- Flash pyrolysis:
- technology for synthesizing chemicals based on high temperature pyrolysis of metal salt solutions.
- Formulation:
- Form under which the drug is administered (tablets, effervescent), injectible…
G
- Galenic formulation:
- See formulation.
- GC-MS:
- this is an analysis method that combines gas chromatography with mass spectrometry to analyze the purity of a product and to determine its molecular mass.
- Generic:
- Copy of a drug whose patent has expired.
- Generic "plus":
- a generic, for which a patentable (and generally more cost effective) alternative synthesis method or a more efficient formulation method has been developed.
- GM:
- General Management.
- GPAO:
- computer-aided management.
- GTL (Gas-To-Liquid):
- methods for producing higher hydrocarbons from gases; these methods are designed to convert the abundant resources of natural gas into liquid hydrocarbons to meet the needs of petrochemistry.
H
- Halogenation:
- introduction of a halogen (a fluorine, chlorine, bromine or iodine atom) into a molecule.
- Head space:
- highly sensitive analysis technique particularly suitable for the detection of residual solvents.
- HPLC (High Pressure Liquid Chromatography) and HPLC-MS:
- scientific instrument for determining the purity of a composite (and the identification of products through their molecular mass).
- HTS (High Throughput Screening):
- screening at high speed.
I
- IAM (Imaging and Advanced Materials):
- products for graphic arts, surface treatment and precursors of advanced materials.
- Immunogenicity:
- The properties of a virus, compound or recombinant protein that provokes an immune response when injected into a human body. This undesirable reaction demonstrates that this protein is sufficiently different to the human to be recognized as a foreign body and rejected by the Immune system.
- Inactinic light:
- describes radiation without any activity on photosensitive products under usual illumination conditions
- In-vitro:
- Experiment carried out outside the body of a patient or animal.
- In-vivo:
- Experiment carried out in the body of a patient or animal.
- ISO (International Standard of Organization):
- acronym for « International Standard of Organization ».
K
- Key Technologies:
- special manufacturing methods for preparing an active ingredient after several steps, which may involve specific expertise. An example is the possibility of working at a very low temperature (-90°C) to better handle a reactive in order to minimize non-desirable by-products and facilitate access to the given product.
- Kilo-lab:
- unit for low yields (around 1kg), located between the laboratory scale (a few hundred grams) and that of the pilot (10-100kg).
L
- LCD (Liquid Cristal Display):
- flat screen technology based on the use of liquid crystals.
> - LED (Light Emitting Diodes):
- new flat screen technology using organic molecules which, subject to an electric field, are able to emit light directly. Depending on the molecules’ compositions, blue, red and green lights may be emitted and the whole colour palette may be reconstructed by missing these colours. It is expected that this technology will compete with presently available technologies such as CRTs, plasma screens or liquid crystal screens. When the emitting molecules are of very small sizes, this technology will be designated as OLED (Organic Light Emitting Diodes) technology. When the molecules are of a larger size, this will be referred to as PLED (Polymer Light Emitting Diodes) technology.
- Low metal content:
- very small quantity of metallic impurities.
- Low temperature reactions or cryogenic reaction:
- chemical reactions conducted between -20°C and -80°C.
M
- Marketing Authorization of drugs (AMM):
- the health regulatory authorities assign a registration number to any new drug, for its market authorization. This number may be found on the medicine packet.
- Metal salts and oxides:
- metal inorganic derivatives (especially nitrates).
- Micro-organism:
- living microscopic organism formed from a single individualized cell and apt at identically reproducing itself forming colonies. It can be seen only with the aid of a microscope, also called microbe.
- Mineral chemistry:
- refers essentially to compounds that do not contain carbon atoms.
- Molecular evolution:
- the result of mutations (DNA changes which can be inherited of genetic material).
N
- Nanopowders:
- ultrafine powders with a particle size less than 1 micron (1 nanometre = 10-9 m, i.e. 0.000000001 metres).
- New chemical entities (NCEs):
- patent-protected pharmaceutical compounds that may be produced only by the patent holder or any company authorized for their production or usage.
- Niche:
- expertise or a particular profitable differentiation with respect to the competition.
- NMR (Nuclear Magnetic Resonance):
- structural analysis device enabling one to check the “skeleton” of organic molecules, especially ’Carbon & Hydrogen’.
O
- OBSAR:
- Bonds with equity warrants attached
- OECD:
- Organization for Economic Co-operation and Development.
- OLED:
- see LED.
- Optically active molecule:
- molecule which causes the plane of polarisation of light to deviate and generally having an asymmetric component.
- Optoelectronics:
- technologies which are at the interface of photons and electrons (e.g. passing from an optical fibre to an integrated circuit).
- Organometallic:
- chemistry in which a metal-carbon link exists in the compound.
- OTC (Over The Counter):
- drugs sold without a prescription.
P
- Pharmaceutical active ingredient:
- this is the substance(s) which give(s) the drug its therapeutic effect. This substance may be obtained by chemical synthesis resulting from many steps, by hemisynthesis or biological methods.
- Pharmaceutical salts:
- bismuth or magnesium compounds with therapeutic (antibacterial features, or which may be used in galenic science).
- Pharmaceutical synthesis:
- succession of chemical steps leading to a molecule with therapeutic properties, or to one of its intermediates.
- Phase-in:
- REACH terminology for substances wich are pre-registration candidates.
- PhD:
- abbreviation to designate Philosophiæ doctor.
- Photoresist:
- photosensitive formulation for use in the process of transferring an image or pattern onto a substrate. The microelectronics industry uses this for manufacturing memories and microprocessors, very advanced photoresists which are applied under very specific conditions for pattern (circuit) with a line thickness of 120nm (nanometres).
- Photosensitive materials:
- materials which react at molecular level to light or a portion of the light spectrum (at a given wavelength) or to other kinds of radiation.
- Photovoltaics:
- a technology converting energy from light (mostly solar energy) into an electric current.
- Pilot:
- intermediate plant between the laboratory and factory at an industrial scale consisting of medium-sized equipment which is required for industrial testing of syntheses before scaling up to real production. The operating procedures may be monitored and adjusted with the pilot plant and the requirements in industrial equipment may be anticipated. Regarding quality, it is also often possible to produce small size validation batches which are less costly than industrial batches.
- PLED:
- see LED.
- POI (internal operation plan):
- description of an emergency plan in case of accident. It is limited to the interior of the establishment and its immediate environment.
- Polysiloxanes:
- polymers consisting of a linked chain of oxygen, silicon, carbon and hydrogen atoms.
- PPI (off-site emergency plan):
- emergency plan drawn up under the responsibility of the"Préfet" (Government representative) concerning the organization of civilian safety and the prevention of major risks. It sets out the emergency measures in case of an accident which impacts the exterior of the site.
- PSI:
- Proteus Services for Industries.
- Precursor of advanced materials:
- molecular entity generally containing a metal which may be deposited by various techniques to form a film or thin layer imparting functional (such as conducting, semi-conducting, anti-reflecting, dielectric, piezoelectric…) properties to a material so that it may be used in high-tech applications.
- Princeps:
- this is the original drug as opposed to the generic drug.
- Protein:
- A class of high molecular weight polymer compounds composed of a variety of a-amino acids (20) joined by peptide linkages and produced by every living organism, whether unicellular or multi-cellular. Each protein is the ultimate expression product of a gene.
Q
- QA:
- Quality Assurance.
- QC (quality control):
- verifies the compliance of products with specifications.
R
- Ranking:
- Prioritising.
- REACH (Registration, Evaluation and Authorisation of Chemicals):
- European regulatory project for the assessment of the risks of market introduction of chemical products.
- Reduction reaction:
- chemical reaction frequently utilising hydrogen sources like sodium borohydride.
- Regulatory Affairs:
- department responsible for drafting, editing and filing documentation with the regulatory authorities, and then following up and updating the documentation required for registration of the active pharmaceutical ingredient.
- Regulatory files:
- set of documents relating to the work accomplished in connection with the issue of a market authorization for a given drug. These documents confirm the reliability and reproducibility of the synthesis and analysis of the active ingredient, of the identification and quantification of possible impurities for the whole of the clinical trials…Each file may contain several thousand pages.
S
- Seveso:
- Italian site where a serious chemical accident occurred in 1976 (substantial releases of dioxin). For better control of chemical hazards, the authorities (urged by their public opinions), traumatised by this accident, enacted guidelines for better control and classification of chemical hazards (the so-called Seveso I – 1982, followed by Seveso II – 1996). Seveso or non-Seveso classifications are performed under consideration of the inventory levels of hazardous materials, handled on-site. The « Seveso » sites for PCAS are the Bourgoin, Couterne, Aramon (Expansia) and Mourenx (SBS).
- Shuffling:
- DNA mutagenesis by random fragmentation and reassembly, of a family of genes from diverse species to accelerate directed evolution.
- Special dyes:
- generally highly sophisticated dyes, especially synthesized for market niche applications, as for example in the electronics industry.
- Sulphur products (odourless):
- additives containing sulphur which are particularly beneficial to performance lubricants as they limit wear. The sulphur odour in the last generation of additives has been removed.
- Synthesis intermediates:
- defined chemical used as raw material in a subsequent synthesis step.
T
- Toll manufacturing:
- activity which consists of manufacturing products for a prime contractor.
- Technical fluids:
- lubricants, fuels, hydraulic fluids…used in industrial processes.
- Therapeutic protein or Biologic:
- Protein derived from a living source (human, animal or unicellular). Most biologics are complex mixtures that are not easily identified or characterized, and many are manufactured using biotechnology. Biological products often represent the cutting-edge of biomedical research and are sometimes the most effective way to prevent or treat a disease.
- Thermophile:
- a micro-organism which can live at high temperatures, surpassing the 100°C.
- Thiophene chemistry:
- a five membered aromatic ring bearing a sulphur atom and frequently used in the synthesis of intermediates for pharmaceutical use.
|
