Description

Sipuleucel T CAS NO 917381-47-6 is a cell-based therapeutic vaccine designed to stimulate a patient's own immune system to target prostate cancer cells. This product matters as it represents a significant advancement in autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer. It is specifically needed by advanced pharmaceutical manufacturers, biotechnology firms, and clinical research organizations engaged in the development and production of personalized cancer immunotherapies.

Application

• Primary Therapeutic Use: Manufacture of Provenge® (sipuleucel-T), an FDA-approved autologous cellular immunotherapy for metastatic castration-resistant prostate cancer (mCRPC).
• Clinical Research: Serving as a key active pharmaceutical ingredient (API) in investigational new drug (IND) applications and clinical trials for advanced prostate cancer.
• Biopharmaceutical Development: Used in R&D for optimizing antigen-presenting cell (APC) activation and T-cell stimulation protocols.
• Oncology Immunotherapy Platforms: A critical component in the development of next-generation, personalized cancer vaccine platforms targeting specific tumor antigens.
• Cell Therapy Manufacturing: Integral to Good Manufacturing Practice (GMP) facilities specializing in patient-specific autologous cell therapies.
• Academic & Institutional Research: Utilized in immunological studies to understand mechanisms of action for dendritic cell-based vaccines.

Basic Information

Product Name	Sipuleucel T
CAS No.	917381-47-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Provenge; APC8015; Sipuleucel-T; Autologous Cellular Immunotherapy; PAP-GM-CSF Fusion Protein Activated Autologous PBMC; Prostate Acid Phosphatase-Granulocyte-Macrophage Colony-Stimulating Factor Vaccine
EINECS	Contact for details

Quality Control

Our Sipuleucel T is manufactured under stringent conditions to ensure the highest standards of purity, potency, and consistency required for advanced therapeutic applications. Quality is assured through a comprehensive battery of tests including cell viability, potency assays, sterility testing (according to USP <71>), endotoxin levels (LAL test), and identity confirmation. All batches are supported by a detailed Certificate of Analysis (COA) documenting compliance with relevant specifications. Production adheres to current Good Manufacturing Practices (cGMP) guidelines suitable for clinical and commercial pharmaceutical use.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store frozen at -70°C or below in a controlled, monitored ultra-low temperature freezer. Avoid repeated freeze-thaw cycles. Thaw under controlled conditions as per the approved handling protocol. The product is light-sensitive and must be stored away from light during all handling and storage steps outside the primary container.

Specification

Item	Specification
Appearance	White to off-white cellular suspension
Identification (Flow Cytometry)	Complies
Cell Viability	≥ 70.0%
Potency (Antigen Presentation)	Complies with release criteria
Sterility (USP <71>)	Sterile
Endotoxin (LAL)	< 5.0 EU/mL
Mycoplasma	Negative
Purity (CD54+ Cell Population)	Meets established range

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