Naming Biologics

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:

• 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

• 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)

• 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 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

• 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