Pembrolizumab (CAS 1374853-91-4) | High Purity API Powder

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Premium Pembrolizumab (CAS 1374853-91-4) high-purity API powder from Shaanxi Sunrise. ≥99% SEC-HPLC purity, low endotoxin, ideal for ADC development, IVD, and research. Global cold-chain shipping available. Request a COA today.



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Description


Pembrolizumab (High-Purity API Powder)

Premium Humanized IgG4 Monoclonal Antibody | CAS 1374853-91-4
⚠ DECLARATION: For Industrial Manufacturing & Scientific Research Only. Strictly not for human or clinical use.
Purity ≥99% (SEC-HPLC)
Low Endotoxin (≤1.0 EU/mg)
Full COA & MSDS Provided
Global Cold-Chain Shipping
Pembrolizumab 1
Handling & Storage: Lyophilized powder should be stored tightly sealed at -20°C to -80°C for long-term stability. Avoid repeated freeze-thaw cycles after reconstitution.

Product Overview

Pembrolizumab, supplied by Shaanxi Sunrise Pharmaceutical Co., Ltd., is an advanced, highly purified biological raw material. As a humanized monoclonal antibody of the IgG4 kappa isotype, it is engineered for critical applications in immunology research, in-vitro diagnostics (IVD), and Antibody-Drug Conjugate (ADC) innovation. Our production complies with rigorous industrial standards to guarantee absolute batch-to-batch consistency.

CAS Registry No. 1374853-91-4
Purity (SEC-HPLC) ≥99.0% (Monomer)
Endotoxin Level ≤ 1.0 EU/mg (LAL Test)
Molecular Weight Approx. 146.3 kDa / 149 kDa (Glycosylated)
Isotype Humanized IgG4 (kappa light chain)
Physical State Sterile filtered white lyophilized powder
Target Antigen Human PD-1 (Programmed Cell Death Protein 1)
Grade Biochemical Research & Industrial Grade

Mechanism of Action (MOA)

Immunological Targeting: Pembrolizumab functions as a highly selective neutralizing antibody. It binds directly to the Programmed Cell Death Protein 1 (PD-1) receptor expressed on the surface of T-cells. By blocking the interaction between the PD-1 receptor and its specific ligands (PD-L1 and PD-L2), it prevents the inhibitory signaling pathway that typically suppresses T-cell activation. In research environments, this molecule is essential for studying T-cell proliferation, cytokine production, and tumor immune evasion mechanisms.

Strict Quality Control (QC) Parameters

Purity & Structural Integrity

We utilize Size-Exclusion Chromatography (SEC-HPLC) to ensure aggregate levels are minimal, and Capillary Electrophoresis (CE-SDS) to verify precise molecular mass and structural integrity.

Biological Activity

Every batch undergoes rigorous binding affinity assessments via ELISA and Surface Plasmon Resonance (SPR) to confirm its potent binding capacity to human PD-1.

Safety & Contaminant Free

Strictly monitored for endotoxins using kinetic LAL assays (≤1.0 EU/mg). Products are filtered through 0.22 μm sterile membranes prior to lyophilization.

Industrial & Research Applications

  • Novel ADC Formulation: Serves as a pristine antibody backbone for synthesizing state-of-the-art Antibody-Drug Conjugates, ensuring stable linker attachment without degradation.

  • In-Vitro Diagnostics (IVD): Acts as a reliable primary binding reagent or positive control in the manufacturing of ELISA kits, flow cytometry panels, and immunohistochemistry (IHC) assays.

  • Biochemical Screening: Indispensable for high-throughput screening arrays analyzing immune checkpoint pathways and T-cell functional recovery.

Procurement FAQ

How is the biological stability maintained during international shipping?
To preserve protein structure and binding affinity, Pembrolizumab is shipped as a stable lyophilized powder using specialized cold-chain logistics (dry ice/blue ice packaging). Real-time temperature loggers can be included upon request.
Can I request custom buffer formulations or liquid formats?
Yes. While our standard offering is lyophilized from a PBS buffer, Shaanxi Sunrise provides custom OEM/ODM services. We can adjust buffer compositions (e.g., adding Trehalose or specific surfactants) and offer liquid formats based on your manufacturing requirements.
What is the lead time for bulk (kg-level) orders?
For standard gram-level R&D orders, products are dispatched within 3-5 working days. For bulk commercial scaling (kilogram level), please allow a lead time of 3-4 weeks. Contact our team directly for precise supply chain scheduling.

Partner with Shaanxi Sunrise Pharmaceutical

Secure your supply of premium Pembrolizumab API with a globally trusted manufacturer.

Inquiry for Batch Pricing & COA
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Email: betty@pharma-sunrise.com
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