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- Under the Guidance, biological products will be identified by a nonproprietary name or “proper name,” consisting of a “core name” plus an FDA-designated suffix.
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What is the INN-USAN-harmonized nomenclature scheme for substances for cell therapy?
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What is the nomenclature scheme for substances for cell-based gene therapy?
Apr 13, 2021 · The World Health Organization assigns international nonproprietary names (INN), also known as common names, to compounds upon request from drug developers. Structures of INNs are publicly available and represent a source, albeit underused, to understand trends in drug research and development.
- Marta Serafini, Sarah Cargnin, Alberto Massarotti, Gian Cesare Tron, Tracey Pirali, Armando A Genazz...
- 2021
Mar 25, 2024 · Non-Proprietary Name. The non-proprietary name of a drug is the name accepted by a competent scientific body or authority, such as the USAN or BAN. The non-proprietary names of newer drugs are kept uniform by an agreement to use the Recommended International Nonproprietary Name (rINN) in all member countries of the World Health Organization (WHO).
Jan 28, 2021 · The current nomenclature scheme for cell-based substances can be found in the 2019 version of the INN document International Nonproprietary Names (INN) for biological and biotechnological substances (BioReview 2019) . The BioReview 2019 summarizes the naming scheme for advanced therapy products, including CT, GT and CGT, and is also published ...
- Ursula Loizides, Massimo Dominici, Tony Manderson, Menico Rizzi, James S. Robertson, Sofia de Sousa ...
- 10.1016/j.jcyt.2021.02.114
- 2021
- Cytotherapy. 2021 May; 23(5): 357-366.
Table 4 shows the nomenclature scheme to name all genetically modified substances for cell-based gene therapy, with the exception of minimally manipulated hematopoietic elements and combinations of substances, which are not named. Table 4: Nomenclature scheme for genetically modified substances for cell-based therapy.
- International Nonproprietary Names (INN) Programme
- General policies for monoclonal antibodies [ 1, 3, 11, 23] 4
- Prefix
- General policies for immunoglobulins fractionated from plasma [ 9, 10]
- 2.10.General policies for skin substitutes [ 4]
- 2.12.General policies for vaccines [ 4- 7]
- CURRENT CHALLENGES
- The previous naming scheme for monoclonal antibodies
- Prefix:
- -toxa- infix
Technologies Standards and Norms (TSN) Regulation of Medicines and other Health Technologies (RHT) Essential Medicines and Health Products (EMP) International Nonproprietary Names (INN) for biological and biotechnological substances
INN for monoclonal antibodies (mAb) are composed of a prefix, a substem A, a substem B and a suffix. The common stem for mAbs is -mab, placed as a suffix. The stem -mab is to be used for all products containing an immunoglobulin variable domain which binds to a defined target. Substem B indicates the species on which the immunoglobulin sequence...
The prefix should be random, i.e. the only requirement is to contribute to a euphonious and distinctive name.
Not to select an INN for immunoglobulins fractionated from plasma is the current policy. The "systematic" or descriptive name is essential since the prescriber must know all the information conveyed by it and there is no benefit in assigning an INN from which it will not be readily apparent.
The products within this system are made of cells within a matrix, and skin substitutes can be considered to be engineered tissue and thus fall outside the scope of the INN system.
(under discussion) Vaccines are traditionally considered to be medicinal substances used to stimulate an individual’s immune system into providing protection against a particular infectious disease. Traditional vaccines consist of whole killed pathogens, live attenuated pathogens, subunits (antigens) derived from pathogens, or inactivated pathogeni...
The challenges currently faced by the INN Expert Group include: The use of a Biological Qualifier separate from the INN scheme to identify the source of a biological substance to enable substances to be traced in different licensing systems, whether classified as ‘similar biological substances’ or not. Formulation of policies for naming fusion prot...
The common stem for monoclonal antibodies is Sub-stems for source of product: -mab. The distinction between chimeric and humanized antibodies is as follows: chimeric antibody is one that contains contiguous foreign-derived amino acids comprising the entire variable region of both heavy and light chains linked to heavy and light constant regions...
Should be random e.g. the only requirement is to contribute to a euphonious and distinctive name.
For monoclonals conjugated to a toxin, the infix -toxa- can be inserted either into the first (main) name or included in the second word.
Apr 4, 2021 · The World Health Organization assigns international nonproprietary names (INN), also known as common names, to compounds upon request from drug developers. Structures of INNs are publicly available and represent a source, albeit underused, to understand trends in drug research and development.
Jan 18, 2017 · Under the Guidance, biological products will be identified by a nonproprietary name or “proper name,” consisting of a “core name” plus an FDA-designated suffix.
