2015-11-29-世界卫生组织-INN_Nomenclature_Scheme_for_Cell_Therapy_Products_CTP_3页_91kb

INN Nomenclature Scheme for Cell Therapy Products (CTP)

Core Content

The International Nonproprietary Names (INN) Programme has developed a nomenclature scheme for cell therapy products (CTP), which was formally finalized and approved during the 61st INN Consultation in 2015. This standardized naming system aims to provide a clear, consistent, and internationally recognized naming convention for CTPs, facilitating communication, regulation, and identification across different countries and institutions.

The nomenclature follows a three-part structure:

• Prefix: A random element used to ensure the name is euphonious and distinctive. Examples include al-, bet-, val-.
• Infixes: Used to specify the type of manipulation and the primary cell type.
• Suffix: Fixed as -cel to denote the product as a cell therapy.

Main Points

1. Prefix

• The prefix is a random component, chosen to make the name sound natural and avoid confusion.
• It is not tied to any specific meaning and is used to differentiate names.

2. Infixes

a) Manipulation Infixes

• These are used to indicate the type of manipulation applied to the cells.
• Multiple manipulation infixes may be included in the same INN.
• Examples:
  • -gen-: transduced (genetic modification)
  • -fus-: fusion to a cell

b) Cell Type Infixes

• These are used to identify the primary cell type in the therapy.
• When available, existing infixes are preferred to maintain consistency.
• Examples:
  • -den-: dendritic cells
  • -mio-: myoblasts
  • -tem-: stem cells
  • -defitem-: differentiated stem cells
  • -leu-: lymphocytes, monocytes, or antigen presenting cells (APCs), including those that do not fit specific categories like dendritic cells

c) Exclusions

• The scheme does not apply to:
  • Minimally manipulated hematopoietic elements
  • Combination products

Key Information

• Manipulation and cell type details are not included in the INN itself but are specified in the product description.
• Residual or contaminating cells are not named in the INN.
• The suffix "-cel" is always used to identify the product as a cell therapy.
• The prefix is not standardized and may vary, but it is chosen to ensure the name is distinct and phonetically acceptable.

Summary

The INN nomenclature scheme for cell therapy products (CTP) is a standardized system designed to provide clear and consistent names for these advanced therapies. It includes a prefix, manipulation infix, cell type infix, and a fixed suffix "-cel". The prefix is random and used to enhance the name's distinctiveness, while the infixes are used to specify the type of manipulation and the primary cell type. Manipulation details such as expansion or activation are included in the product description rather than the INN itself. The scheme excludes minimally manipulated hematopoietic elements and combination products. It also does not name residual or contaminating cells. This system supports global understanding and regulatory consistency in the field of cell therapy.