• A
  • |
  • A
  • Text size

Naming Biologics

The USAN Council has been involved in coining names for various biological products: the 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 an increasingly greater role in assigning names and developing nomenclature rules for these agents.

Please use the following Microsoft Word document sequence templates to submit in a table format:

USAN and INN requirements for biological substances

All proteins and peptides

  • complete mature amino acid sequence in a MIcrosoft Word document
  • single-letter codes for each amino acid, displayed in groups of 10 characters with five 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 in a Microsoft Word document
  • single-letter codes for each amino acid, displayed in groups of 10 characters with five 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
  • 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)

Nucleic acids (includes DNA vaccines, oligonucleotides, 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