The USAN Council is involved in coining names for various biological products: insulins, interferons, interleukins, growth hormones, colony-stimulating factors, cytokines, monoclonal antibodies and coagulation factors. With increasing development of highly purified biological extracts and recombinant materials, the council has had a greater role in assigning names and developing nomenclature rules for these agents.
Please use the following MS Word document sequence templates to submit in a table format:
- Sequence template (DOC) required when submitting all proteins and peptides
- Sequence template (DOC) required when submitting monoclonal antibodies
USAN and INN requirements for biological substances include the following:
All Proteins and Peptides
- Complete mature amino acid sequence (DOC) in a MS Word document
- Single-letter codes for each amino acid, displayed in groups of 10 characters with 5 groups per line and a number indicating the position of the last amino acid at the end of each line
- Positions of all disulfide bridges and post-translational modifications should be listed after the sequence
- Glycosylation patterns (including site, type of sugar, etc.)
- For recombinant proteins: Expression system and comparison with native sequence
Monoclonal Antibodies
- Complete mature amino acid sequence (DOC) in a MS Word document
- Single-letter codes for each amino acid, displayed in groups of 10 characters with 5 groups per line and a number indicating the position of the last amino acid at the end of each line
- Glycosylation patterns (including site, type of sugar, etc.)
- Precursor nucleotide sequence with spaces between codons and translation, with numbered lines
- CDR-IMGT (DOC)
- IG class and subclass, IG format
- Species or taxonomy related structure (chimeric, humanized, etc.)
- Name and/or structure of targeted antigen
- List of all disulfide bridges and their locations
- Expression system
- Clone name(s) and laboratory code name(s)
Cell Therapies
- Name/code designation
- Characterization/description
- Cell source
- List and description of manipulation (culture conditions included)
- If genetic manipulation: the detailed description of the vector and insert should be provided
Nucleic Acids
Nucleic acids include DNA vaccines, oligonucleotides and gene therapy products.
- Full nucleotide sequence with pertinent regions (e.g., coding regions, control regions) delineated
- For gene therapies, schematic map of the product and an annotated sequence that delineates relevant sections
All Pegylated Substances
- Details of pegylation: end group, polymer chain (with average number of repeat units to two significant figures), details of the linker, point of attachment of the linker to the active moiety
