UNII R0835E18NH

LIFILEUCEL

UNII Information

Unique Ingredient Identifier: R0835E18NH
The Unique Ingredient Identifier (UNII) is a unique alphanumeric code assigned to a specific substance or ingredient by the FDA (Food and Drug Administration). UNII codes are non-proprietary, free, unique, unambiguous and nonsemantic. Each UNII code consists of 10 characters with both letters and numbers. The first two characters represent the source of the substance while the remaining eight characters represent the specific substance. UNII codes are primarily used to identify and track substances in several drug databases and regulatory documents related to drugs, biologics, and medical devices.
Formula: R0835E18NH
Molecular Formula, total atoms represented as a molecular structure in a UNII description.
Preferred Substance Name: LIFILEUCEL
The Preferred Substance Name (PSN) is the official or preferred name of a substance or ingredient. The preferred name provides a standardized and consistent name for each substance is used in the UNII code system. The preferred name may differ from other names also commonly used to refer the same substance. The PSN is usually the name used by regulatory agencies like the FDA.
Registry Number: 2306267-74-1
The Registry Number is the unique numerical identifiers assigned to a substance or ingredient by the Chemical Abstracts Service (CAS). The CAS registry number is a used and recognized standard identifier by many industries and regulatory agencies. The Registry Number facilitates cross-referencing substances between different databases that may use different naming conventions or identifiers.
NCI Thesaurus Concept Code: C120552
The NCI Thesaurus give reference terminology for many systems. The code includes vocabulary for clinical care, translational research, basic research, public information and administrative activities.
ITIS TSN: 180092
The Taxonomic Serial Number is a unique identifier for a specific species of organism in the Integrated Taxonomic Information System. The ITIS is a comprehensive database of taxonomic information on plants, animals, fungi, and microbes, maintained by a partnership of several US government agencies.
NCBI: 9606
The NCBI taxonomy organism ID is a unique numeric identifier used to specify species of organisms by the National Center for Biotechnology Information (NCBI) Taxonomy database.
INN ID: 10728
Sequential number assigned by World Health Organization's International Nonproprietary Name (INN).
Substance Type: structurallyDiverse
The International Organization for Standardization - ISO 11238 substance type is used as a data element in the UNII code system to provide additional information about the type of substance being identified.

UNII Synonyms and Mappings

The following synonyms and mappings provide alternative ways to refer to the same substance or ingredient. Synonyms may include different names or spellings, alternate chemical names, trade names, or other common names.

  • AMTAGVI - Brand/Trade Name
  • AN AUTOLOGOUS CD4+ AND CD8+ TUMOR INFILTRATING LYMPHOCYTE, DERIVED FROM ISOLATED METASTATIC MELANOMA CULTURED IN THE PRESENCE OF FEEDER CELLS (IRRADIATED ALLOGENEIC MONONUCLEAR CELLS FROM HEALTHY DONORS), AND HUMAN RECOMBINANT INTERLEUKIN 2/MUROMONAB-CD3 FOR TREATMENT OF METASTATIC MELANOMA - Common Name
  • AUTOLOGOUS TUMOR-INFILTRATING LYMPHOCYTES (TIL) DERIVED FROM THE PATIENT'S OWN TUMOR. - Common Name
  • HUMAN CULTURE EXPANDED ACTIVATED AUTOLOGOUS T CELLS FOR CELL-BASED IMMUNOTHERAPY. THE CELL SUBSTANCE IS A HETEROGENEOUS MIXTURE CONSISTING OF CD4+ AND CD8+ TUMOR-INFILTRATING LYMPHOCYTES (TIL), DERIVED FROM ISOLATED TUMOR BIOPSY OF PATIENTS WITH MELANOMA OR CERVICAL CARCINOMA, AND CULTURED IN THE PRESENCE OF FEEDER CELLS (IRRADIATED ALLOGENEIC MONONUCLEAR CELLS FROM HEALTHY DONORS) AND HUMAN RECOMBINANT INTERLEUKIN 2 (IL-2)/OKT3 ANTI-CD3 ANTIBODY (MUROMONAB-CD3 (59) (29) FOR T-CELL ACTIVATION - Common Name
  • LIFILEUCEL - Name identified as having official status
  • LIFILEUCEL [INN] - Common Name
  • LIFILEUCEL [USAN] - Common Name
  • LIFILEUCEL [WHO-DD] - Common Name
  • LN 145 [WHO-DD] - Common Name
  • LN-144 - Code
  • LN-145 - Code
  • TUMOR INFILTRATING LYMPHOCYTES, AUTOLOGOUS (FROM MELANOMA TUMORS) - Common Name
  • TUMOR-INFILTRATING LYMPHOCYTES (TIL). THE PROCESS FOR MANUFACTURING LIFILEUCEL BEGINS AT THE CLINICAL SITE WITH THE EXCISION OF TUMORS OF >= 1 CM FROM METASTATIC SITES, INCLUDING LYMPH NODES. TUMOR TISSUE IS PLACED IN MEDIA AND SHIPPED BY OVERNIGHT COURIER TO THE GMP CENTRALIZED MANUFACTURING SITE, IN COOLED (2-8?C) TEMPERATURE-MONITORED CONTAINERS. NEXT, IN THE PRE RAPID EXPANSION PROTOCOL (PRE-REP) STEP, SMALL FRAGMENTS OF PATIENT TUMOR ARE CULTURED WITH HUMAN RECOMBINANT INTERLEUKIN 2 (IL-2) IN A SMALL SCALE CULTURE FOR 11 DAYS TO GENERATE >= 5 MILLION TIL. TIL NUMBERS ARE EXPANDED USING THE RAPID EXPANSION PROTOCOL (REP), IN WHICH THE PRE-REP TIL ARE CULTURED FOR AN ADDITIONAL 11 DAYS IN THE PRESENCE OF FEEDER CELLS (IRRADIATED ALLOGENEIC MONONUCLEAR CELLS FROM NORMAL DONORS), IL-2, AND THE OKT3 ANTI-CD3 ANTIBODY (FOR T-CELL STIMULATION). THE CULTURE IS THEN HARVESTED AND THE CELLS WASHED, CONCENTRATED, AND SUSPENDED IN A FINAL TRANSPORT MEDIA AND CRYOPRESERVED (<= -150?C). THE PRODUCT IS SHIPPED BY COURIER TO THE TREATMENT SITE IN TEMPERATURE-MONITORED CONTAINERS. - Common Name

UNII Resources

Common Chemistry
CAS Common Chemistry is an open community resource of the American Chemical Society for accessing chemical information. The chemical information in the CAS database is curated by expert scientists and includes information of common and frequently regulated chemicals and information applicable to high school and undergraduate chemistry classes.
Inxight Drugs
The National Center for Advancing Translational Sciences (NCATS) Inxight Drugs database has a comprehensive drug development information. The NCATS Inxight Drugs includes manually curated data provided by private companies and FDA. The database has marketing and regulatory status information, rigorous drug ingredient definitions, biological activity, clinical use, etc.
DailyMed Regulated Products
The National Library of Medicine DailyMed is a searchable database that includes the most recent product labeling information submitted to the FDA by private companies.
NCATS GSRS Full Record
The Global Substance Registration System (GSRS) was designed to facilitate global monitoring of human and animal medicinal, food, tobacco, and cosmetic products. GSRS includes unique substance identifiers consistent with the ISO 11238 standard.
NCI Thesaurus
NCI Thesaurus (NCIt) by the National Cancer Institute provides reference terminology for clinical care, translational and basic research, and public information and administrative activities.

UNII Crossover to NDC Codes

This unique ingredient identifier is listed as an ingredient or substance in the following products in the NDC directory:

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Status
73776-001Proprietary Name: Amtagvi LifileucelSuspensionIntravenousIovance Biotherapeutics Inc.ACTIVE