Tixagevimab API Manufacturer in India | CAS 2420564-02-7 | Swapnroop Pharma

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Tixagevimab API Manufacturer in India

Tixagevimab API is a recombinant human IgG1-kappa monoclonal antibody directed against the receptor-binding domain of the spike protein of SARS-CoV-2. It is a long-acting neutralizing monoclonal antibody developed to bind the viral spike protein and interfere with its interaction with the human ACE2 receptor.

Tixagevimab is also known by the development codes AZD8895 and COV2-2196. It is produced using recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. FDA documentation identifies Tixagevimab as a recombinant human IgG1κ monoclonal antibody with Fc-region modifications designed to reduce Fc-mediated effector functions and extend antibody half-life through enhanced FcRn binding.

Swapnroop Pharma offers Tixagevimab for qualified pharmaceutical and biopharmaceutical development, research and bulk biologic requirements.

Tixagevimab API Overview

Tixagevimab is a recombinant monoclonal antibody targeting the receptor-binding domain of the SARS-CoV-2 spike protein. It was developed as one component of the tixagevimab/cilgavimab monoclonal antibody combination known as Evusheld.

Tixagevimab binds to a distinct epitope on the SARS-CoV-2 spike receptor-binding domain and blocks interaction between the viral spike protein and the human ACE2 receptor.

The antibody consists of two identical heavy chains and two identical light chains. PMDA describes each heavy chain as containing 461 amino acid residues and each light chain as containing 216 amino acid residues, giving an approximate molecular weight of 149,000 Da for the glycoprotein.

Chemical and Biopharmaceutical Profile

Product Name: Tixagevimab

API Name: Tixagevimab

CAS Number: 2420564-02-7

UNII: F0LZ415Z3B

Development Code: AZD8895

Alternative Code: COV2-2196

Molecular Type: Recombinant Monoclonal Antibody

Antibody Class: Human IgG1-kappa

Target: SARS-CoV-2 Spike Protein Receptor-Binding Domain

Production System: Chinese Hamster Ovary (CHO) Cells

Heavy Chain: 461 amino acid residues

Light Chain: 216 amino acid residues

Total Protein Chains: 4

Approximate Molecular Weight: 149,000 Da

Molecular Formula: C₆₄₈₈H₁₀₀₃₄N₁₇₄₆O₂₀₃₈S₅₀

Therapeutic Area: Antiviral / Infectious Disease

Pharmacological Class: Monoclonal Antibody / Antiviral Biologic

Former Combination Product: Evusheld (Tixagevimab + Cilgavimab)

PMDA provides the CAS number, molecular formula, chain composition and approximate molecular weight. FDA's substance database independently identifies CAS 2420564-02-7, UNII F0LZ415Z3B, AZD8895 and COV2-2196 as identifiers for Tixagevimab.

Mechanism of Action

Tixagevimab binds to the receptor-binding domain of the SARS-CoV-2 spike protein. By binding the spike protein, it can interfere with the interaction required for viral attachment and entry into cells through the ACE2 receptor.

Tixagevimab contains engineered Fc-region substitutions. FDA documentation describes Fc modifications intended to reduce Fc-mediated effector functions and YTE-related modifications intended to extend serum half-life through enhanced interaction with the neonatal Fc receptor (FcRn).

Pharmaceutical and Biopharmaceutical Applications

Tixagevimab has been developed primarily for SARS-CoV-2 antiviral and prophylactic applications.

Potential pharmaceutical and biopharmaceutical applications include:

  • SARS-CoV-2 monoclonal antibody research
  • Antiviral biologic development
  • COVID-19 antibody development
  • Recombinant monoclonal antibody research
  • Viral neutralizing antibody studies
  • SARS-CoV-2 spike protein research
  • ACE2-spike interaction studies
  • Biopharmaceutical development
  • Monoclonal antibody formulation development
  • Antiviral biologic research

Regulatory status note: Tixagevimab/cilgavimab was previously authorized/marketed as Evusheld in several jurisdictions, but its regulatory status has changed. The FDA withdrew the US EUA because of reduced activity against circulating variants, and the EMA reports withdrawal of the EU marketing authorization in September 2025. Therefore, the SDP page should describe it as a biopharmaceutical/research and development product rather than implying current clinical authorization.

Tixagevimab API Manufacturer in India

Swapnroop Pharma provides Tixagevimab API sourcing support for qualified pharmaceutical, biotechnology and biopharmaceutical requirements.

As a recombinant monoclonal antibody, Tixagevimab requires biologic-specific quality characterization rather than conventional small-molecule API testing. Product identity, purity, protein concentration, potency, aggregation, charge variants and process-related impurities are evaluated using appropriate validated analytical methods.

Product-specific specifications and documentation can be provided according to the applicable grade and customer requirements.

Tixagevimab Bulk API Supply

Tixagevimab can be supplied for qualified research, development and biopharmaceutical requirements subject to availability and applicable specifications.

Potential documentation may include:

  • Certificate of Analysis (CoA)
  • Product Specification
  • Safety Data Sheet (SDS/MSDS)
  • Technical Data Sheet
  • Batch Analytical Documentation
  • Stability Documentation
  • Regulatory Documentation, where applicable
  • Biologic Characterization Documentation

Quality and Product Characterization

Tixagevimab is a complex recombinant protein biologic. Appropriate quality characterization may include:

  • Identity
  • Protein concentration
  • Purity
  • Aggregates and size variants
  • Charge variants
  • Glycosylation profile
  • Binding activity
  • Biological potency
  • Host-cell protein
  • Residual host-cell DNA
  • Residual Protein A
  • Endotoxin
  • Sterility, where applicable
  • Subvisible particles, where applicable

The FDA describes a comprehensive control strategy for Tixagevimab drug substance and drug product covering quality attributes, purity and potency.

Packaging and Storage

The historical Evusheld formulation contained 150 mg Tixagevimab in 1.5 mL, equivalent to 100 mg/mL, in a sterile, preservative-free solution. The formulation had a reported pH of 6.0.

The finished product was stored refrigerated at 2°C–8°C, protected from light, and was not to be frozen or shaken.

For bulk Tixagevimab drug substance, actual storage conditions should be based on the manufacturer's validated stability data rather than automatically applying the finished-product storage condition.

Documentation

Depending on product grade and customer requirements, documentation may include:

  • Certificate of Analysis
  • Product Specification
  • Safety Data Sheet
  • Technical Data Sheet
  • Batch Analytical Report
  • Stability Data
  • Regulatory Documentation
  • Manufacturing Documentation
  • Biologic Characterization Data
  • Quality and Compliance Documentation

Why Choose Swapnroop for Tixagevimab API?

  • India-based pharmaceutical and biopharmaceutical sourcing
  • Recombinant monoclonal antibody supply support
  • Support for advanced biologic API requirements
  • Product-specific analytical documentation
  • Technical documentation support
  • Bulk biologic sourcing support
  • Domestic and international customer support
  • Flexible documentation and packaging options

Tixagevimab API for Biopharmaceutical Requirements

For pharmaceutical, biotechnology and research organizations seeking Tixagevimab API in India, Swapnroop Pharma provides sourcing support for qualified monoclonal antibody and antiviral biologic requirements.

Contact Swapnroop Pharma for Tixagevimab availability, specifications, analytical documentation, packaging and bulk requirements.

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
pH (1% Solution) 6.0
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