Description

Denileukin Diftitox is a recombinant fusion protein designed for targeted therapeutic applications. This engineered immunotoxin is of significant interest in the pharmaceutical and biotechnology sectors for its specific mechanism of action. It is primarily utilized in advanced research and development for targeted cancer therapies, meeting the stringent demands of pharmaceutical manufacturers and clinical research organizations globally.

Application

• Oncology Research: A key investigational agent in the study of targeted cancer therapies, particularly for T-cell malignancies.
• Pharmaceutical Development: Serves as an active pharmaceutical ingredient (API) in the formulation of specialized immunotherapeutic drugs.
• Biomedical Research: Used as a critical tool in immunology and cell biology research to study interleukin-2 receptor pathways and targeted cell ablation.
• Clinical Trials: Employed in the manufacturing of supplies for Phase I-III clinical trials investigating novel treatment modalities.
• Reference Standard: Acts as a high-purity standard for analytical method development, validation, and quality control testing in GMP environments.

Basic Information

Product Name	Denileukin Diftitox
CAS No.	173146-27-5
Molecular Formula	C₂₆₉₆H₄₁₇₂N₇₁₂O₈₃₀S₁₈
Molecular Weight	~58 kDa
Synonyms	DAB389IL-2; Ontak; E7777; Denileukin diftitox (USAN); Recombinant fusion protein DAB389-IL2; IL-2 fusion toxin; Diphtheria toxin-interleukin-2 fusion protein
EINECS	Contact for details

Quality Control

Our Denileukin Diftitox is manufactured and tested under stringent quality systems. Each batch is subjected to a comprehensive battery of analytical tests to ensure identity, purity, potency, and safety, aligning with ICH guidelines. A detailed Certificate of Analysis (COA) documenting purity by HPLC, biological activity, endotoxin levels, and other critical parameters is provided with every shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store frozen at -20°C or below. Avoid repeated freeze-thaw cycles. The product is hygroscopic (moisture-sensitive); ensure containers are sealed under controlled, dry conditions after each use.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or solid
Identification (HPLC/MS)	Conforms to reference standard
Purity (HPLC)	≥ 95.0%
Assay (Biological Activity)	90% - 110% of labeled potency
Endotoxin	< 10 EU/mg
Residual Moisture (KF)	≤ 5.0%
Sterility (where applicable)	Sterile

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.