Ivonescimab API | PD-1 / VEGF Bispecific Antibody API Manufacturer in India

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

Ivonescimab API

Ivonescimab is an investigational bispecific antibody designed to simultaneously target programmed cell death protein 1 (PD-1) and vascular endothelial growth factor (VEGF). By combining immune-checkpoint inhibition with VEGF blockade in a single molecule, ivonescimab is being developed as a novel approach to cancer immunotherapy.

Ivonescimab is also known as SMT112 and is being investigated primarily in oncology, particularly in non-small cell lung cancer (NSCLC).

Ivonescimab API Manufacturer in India

Ivonescimab is a specialized biological pharmaceutical ingredient requiring recombinant expression and advanced purification and characterization technologies.

Quality evaluation for a bispecific antibody includes assessment of identity, purity, aggregation, charge variants, molecular integrity, target binding, biological potency, glycosylation, host-cell proteins, residual DNA, endotoxins and sterility.

Biological Information

Molecule Type: Bispecific Monoclonal Antibody
Target 1: PD-1
Target 2: VEGF
Drug Class: Antineoplastic / Immunotherapy
Pharmacological Class: PD-1 / VEGF Bispecific Antibody
Therapeutic Area: Oncology
Primary Development Area: Non-Small Cell Lung Cancer

Mechanism of Action

Ivonescimab is designed to simultaneously interact with PD-1 on immune cells and VEGF in the tumor microenvironment.

Its dual-targeting approach is intended to:

  • Block PD-1-mediated immune-checkpoint signaling
  • Enhance T-cell-mediated antitumor activity
  • Neutralize VEGF-mediated signaling
  • Potentially reduce tumor angiogenesis
  • Modify the immunosuppressive tumor microenvironment
  • Combine immune activation and anti-angiogenic activity within one molecule

Pharmaceutical Applications

Ivonescimab is being investigated in oncology, particularly for:

  • Non-small cell lung cancer (NSCLC)
  • Advanced solid tumors
  • Combination cancer-immunotherapy approaches
  • Tumors involving PD-1/PD-L1 and VEGF pathways

As an investigational medicine, its clinical applications should not be presented as established approved indications unless supported by the applicable regulatory authority.

Bispecific Antibody Characteristics

Unlike conventional monoclonal antibodies directed against a single target, ivonescimab is designed to engage two biological targets simultaneously.

This dual-targeting strategy is intended to integrate:

Immune checkpoint inhibition + VEGF pathway blockade

within a single therapeutic molecule.

Recombinant Manufacturing

Typical manufacturing of a bispecific antibody such as ivonescimab may involve:

  1. Recombinant cell-line development
  2. Mammalian cell culture
  3. Protein expression
  4. Harvest and clarification
  5. Primary capture chromatography
  6. Viral inactivation
  7. Polishing chromatography
  8. Viral filtration
  9. Ultrafiltration / diafiltration
  10. Final formulation
  11. Sterile filtration
  12. Aseptic filling

Quality and Analytical Testing

Ivonescimab quality evaluation may include:

  • Identity
  • Protein concentration
  • Purity
  • Aggregate analysis
  • Fragment analysis
  • Charge-variant profiling
  • Molecular-weight characterization
  • Peptide mapping
  • Glycosylation analysis
  • PD-1 binding activity
  • VEGF binding activity
  • Cell-based biological potency
  • Host-cell protein
  • Residual host-cell DNA
  • Residual Protein A
  • Bacterial endotoxins
  • Bioburden
  • Sterility
  • Subvisible particles

Storage

Ivonescimab drug substance or drug product should be stored according to validated stability data and applicable investigational-product requirements. Controlled temperature conditions and protection from inappropriate light exposure are important for maintaining antibody integrity.

Pharmaceutical Research and Development

Ivonescimab is relevant to research involving:

  • Bispecific antibodies
  • PD-1 checkpoint inhibition
  • VEGF inhibition
  • Cancer immunotherapy
  • Tumor angiogenesis
  • Tumor microenvironment
  • Non-small cell lung cancer
  • Solid tumors
  • Recombinant antibody manufacturing
  • Immuno-oncology

Ivonescimab API Summary

Ivonescimab is an investigational PD-1/VEGF bispecific antibody developed for oncology applications. Its mechanism is designed to combine immune-checkpoint blockade and VEGF inhibition in a single biological therapeutic, with development focused particularly on non-small cell lung cancer and other solid tumors.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Individual Impurity NMT 0.5%
Total Impurities ≤ 1.5%
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