Insulin-Like Growth Factor 1 API | Recombinant IGF-1 API Manufacturer in India

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Insulin-Like Growth Factor 1 API

Insulin-Like Growth Factor 1 (IGF-1) is a naturally occurring peptide hormone and growth factor that plays an important role in cell growth, differentiation, metabolism and tissue development. It is primarily produced in the liver in response to growth hormone stimulation and acts through the insulin-like growth factor 1 receptor (IGF-1R).

Recombinant IGF-1 is used in pharmaceutical research, biotechnology and the development of therapeutic products involving growth-factor signaling and endocrine disorders.

Insulin-Like Growth Factor 1 API Manufacturer in India

Insulin-Like Growth Factor 1 is a specialized recombinant peptide/protein pharmaceutical ingredient produced using biotechnology-based expression and purification processes.

Quality evaluation focuses on critical biological and physicochemical characteristics such as identity, purity, molecular weight, peptide content, aggregation, potency, host-cell impurities, residual DNA and microbial quality.

Biological Information

CAS Number: 67763-96-6
Molecular Formula: C331H512N94O101S7
Molecular Weight: 7649.7 g/mol
Amino Acids: 70
Molecule Type: Recombinant Peptide Hormone / Growth Factor
Drug Class: Growth Factor
Pharmacological Class: Insulin-Like Growth Factor
Therapeutic Area: Endocrinology / Growth Disorders

Mechanism of Action

IGF-1 primarily acts by binding to the IGF-1 receptor (IGF-1R), a receptor tyrosine kinase.

Receptor activation initiates intracellular signaling pathways including:

  • PI3K/Akt signaling
  • MAPK/ERK signaling
  • Cellular growth and proliferation
  • Protein synthesis
  • Cell survival
  • Glucose and nutrient metabolism

IGF-1 also has metabolic effects that overlap with insulin signaling.

Physiological Role

IGF-1 is an important mediator of the growth hormone–IGF-1 axis. It contributes to:

  • Linear growth
  • Bone development
  • Cartilage growth
  • Skeletal muscle development
  • Protein synthesis
  • Cell proliferation
  • Tissue repair and differentiation

Circulating IGF-1 levels are influenced by growth hormone, nutritional status, age and several physiological factors.

Pharmaceutical Applications

Recombinant IGF-1 has pharmaceutical relevance in:

  • Growth-factor research
  • Endocrinology
  • Growth disorders
  • IGF-1 receptor research
  • Cell proliferation studies
  • Tissue regeneration research
  • Recombinant peptide development

Recombinant human IGF-1 has also been developed for specific clinical applications involving severe primary IGF-1 deficiency, subject to applicable regulatory approvals.

Recombinant IGF-1

Commercial recombinant IGF-1 is produced using recombinant DNA technology. Manufacturing generally involves:

  1. Recombinant expression
  2. Cell harvest
  3. Protein recovery
  4. Purification
  5. Refolding where required
  6. Chromatographic purification
  7. Final polishing
  8. Concentration and buffer exchange
  9. Sterile processing where applicable
  10. Analytical characterization

Quality and Analytical Testing

IGF-1 quality evaluation may include:

  • Identity testing
  • Peptide mapping
  • Amino-acid sequence confirmation
  • HPLC purity
  • Molecular-weight determination
  • Related proteins
  • Aggregates
  • Potency assay
  • IGF-1 receptor-binding activity
  • Host-cell protein testing
  • Residual host-cell DNA
  • Endotoxin testing
  • Bioburden
  • Sterility where applicable
  • Protein concentration
  • pH

Storage

Insulin-Like Growth Factor 1 should be stored according to validated stability data and applicable product specifications. Recombinant proteins require appropriate temperature control and protection against conditions that may cause aggregation, degradation or loss of biological activity.

Pharmaceutical Research and Development

IGF-1 is relevant to research involving:

  • Growth hormone signaling
  • IGF-1 receptor biology
  • Cell proliferation
  • Protein synthesis
  • Skeletal growth
  • Muscle development
  • Tissue regeneration
  • Endocrine disorders
  • Recombinant protein therapeutics

Insulin-Like Growth Factor 1 API Summary

Insulin-Like Growth Factor 1 is a 70-amino-acid recombinant peptide hormone with CAS Number 67763-96-6 and molecular weight of approximately 7.65 kDa. It mediates important effects on growth, cellular proliferation and metabolism primarily through activation of the IGF-1 receptor.

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 NMT 1.0%
Water Content NMT 1.0%
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