Tremelimumab API Manufacturer and Supplier in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Tremelimumab API Manufacturer and Supplier in India

Swapnroop Drugs & Pharmaceuticals is a manufacturer and supplier of Tremelimumab for pharmaceutical and biopharmaceutical applications. Tremelimumab is a recombinant human IgG2 monoclonal antibody that targets cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), an immune checkpoint receptor involved in regulation of T-cell activation.

Tremelimumab binds CTLA-4 and blocks its interaction with CD80 and CD86, thereby supporting T-cell activation and immune-mediated antitumor activity. It is used as an immune checkpoint inhibitor in oncology.

Tremelimumab API Overview

Tremelimumab is a biological drug substance, not a conventional small-molecule API. It is a recombinant monoclonal antibody produced using mammalian cell culture technology.

The pharmaceutical substance is identified by CAS No. 745921-57-7 and UNII 7LR1Q6DT9K. Tremelimumab has an approximate molecular mass of 149 kDa and is composed of two heavy chains and two light chains.

Tremelimumab is the active antibody component of tremelimumab-actl, used in combination with durvalumab in certain oncology indications.

Chemical and Pharmaceutical Profile

  • Product Name: Tremelimumab
  • CAS Number: 745921-57-7
  • UNII: 7LR1Q6DT9K
  • Molecular Type: Recombinant monoclonal antibody
  • Antibody Isotype: Human IgG2
  • Target: CTLA-4
  • Approximate Molecular Weight: 149 kDa
  • Expression System: Mammalian cell culture
  • Therapeutic Category: Oncology / Immuno-Oncology
  • Mechanism: CTLA-4 immune-checkpoint blockade
  • API Type: Biologic / Monoclonal Antibody
  • Physical Form: Protein solution / biologic drug substance

Pharmaceutical Applications

Tremelimumab is used in pharmaceutical products for oncology applications including:

  • Unresectable hepatocellular carcinoma
  • Metastatic non-small cell lung cancer
  • Advanced or metastatic solid tumors in applicable combination regimens
  • CTLA-4 targeted immunotherapy research
  • Development of antibody-based oncology products

Tremelimumab API Manufacturer and Supplier

Swapnroop Drugs & Pharmaceuticals provides manufacturing and supply support for Tremelimumab API for pharmaceutical and biotechnology customers.

As a Tremelimumab API manufacturer and supplier in India, Swapnroop focuses on controlled biopharmaceutical manufacturing, appropriate antibody characterization, quality documentation and supply requirements applicable to monoclonal antibody products.

Packaging and Storage

Tremelimumab drug substance requires controlled storage and handling conditions appropriate for recombinant monoclonal antibodies. Temperature, light protection and transport conditions should follow the validated product-specific specification.

For finished tremelimumab products, refrigerated storage conditions are used to maintain antibody stability.

Documentation

Typical documentation for Tremelimumab may include:

  • Certificate of Analysis (CoA)
  • Product Specification
  • Batch Analytical Documentation
  • Protein concentration and purity data
  • Identity/characterization data
  • Biological activity/potency data
  • Safety Data Sheet (SDS)
  • Manufacturing Documentation
  • Regulatory Documentation, where applicable
  • Stability Documentation

Why Choose Swapnroop for Tremelimumab?

Swapnroop Drugs & Pharmaceuticals supports pharmaceutical and biotechnology customers seeking reliable Tremelimumab API with controlled biopharmaceutical manufacturing, appropriate characterization and professional technical support.

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
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