Below are definitions of the main terms used on the site.
- Active Partner A CMO that has chosen to manage their own Organization, Location, and Production Line information is considered an Active Partner at CMOLocator.com. Active Partners must have at least 1 production line defined in the database and accurately reflect
their capacity, capability, and availability information. This must be information which is generally available to the public, as CMOLocator is a publically accessible website. Active Partners who do not attempt to accurately reflect their capacity, capability and availability as a CMO may temporarily lose access to their account as the CMOLocator team will add this information during periodic audits. Also, Active Partners must demonstrate activity on the account with at least one login to the system every 6 months.
- Contract Manufacturing Organization A company that offers manufacturing services on a contract basis. CMOs are also known as 3rd-party manufacturers.
- Technology Transfer A systematic procedure for passing the documented knowledge and experience gained during development and/or manufacturing to an appropriate responsible receiving party as well as the demonstrated ability of a receiving party to effectively perform the technical elements of the transferred technology to the satisfaction of all parties and relevant regulatory bodies.
- Good Manufacturing Practices (GMP) A set of written guidelines regulating the manner in which biopharmaceuticals, vaccines, drugs, diagnostic reagents and medical devices are produced to ensure consistent quality, efficacy and safety to the consumer.
- Drug Substance (API) Active Pharmaceutical Ingredient or Active Pharmaceutical Intermediate – Any active bulk substances to be used in the manufacture of a drug product. When used in the manufacturing of a drug it becomes an active ingredient of the drug product. API is commonly used referred to as "bulk."
- Drug Product (Fill/Finish) A finished dosage form (e.g. vial, capsule, etc.) that contains a drug substance (API) in association with one or more other ingredients. Drug product is usually packaged for end use when manufactured. Drug product is commonly used in conjunction with the word "final", such as final drug product.
- Microbial Fermentation A controlled bioreaction process of prokaryotic microorganisms used to create a desired drug substance. In almost all cases, the microorganisms are genetically modified. Common examples of microbial cells used for fermentation include yeast and E.Coli.
- Cell Culture A controlled bioreaction process of eukaryotic microorganisms used to create a desired drug substance. In almost all cases, the microorganisms are genetically modified. A common example of eukaryotic cells used for cell culture is Chinese Hamster Ovary (CHO).
- Biological Safety Level 1 (BSL-1) Suitable for working with well-characterized agents not known to cause disease in healthy adult humans and of minimal potential hazard to laboratory personnel and the environment.
- Biological Safety Level 2 (BSL-2) Suitable for work involving agents of moderate potential hazard to personnel and the environment.
- Biological Safety Level 3 (BSL-3) Suitable for work with infectious agents which may cause serious or potentially lethal disease as a result of exposure by the inhalation route.