Custom Peptide Services

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cGmp Peptide Synthesis

Selleck’s cGMP facilities are designed for large-scale manufacturing of pharmaceutical drug substances for preclinical research. Manufacturing under cGMP is performed under strict adherence to guidelines.

cGMP Peptide Technology Platform GMP compliance
Raw material qualification On-going training
Synthetic method development, validation and scale up In-house Audit
Product Purification Raw material control
GMP/GLP analytic method development and validation Analytical method validation and documentation
Release specification design and testing SOPs
Stability testing (if needed) In process control and batch record
GMP packaging Equipment
GMP compliance documentation Computers
Certificate of Analysis for GMP Peptide
Appearance Amino acid analysis
Purity by HPLC Water content
Heavy metal by ICP-MS Endotoxin
Bioburden or microbial tests Amino acid analysis
Residual organic solvent by GC Peptide Content (nitrogen estimation)
Solubility Counter Ion Content (% TFA) by IC
Molecular Weight by MS

Our cGMP Quality Management

  • Raw Material QC
  • Synthetic Process Validation and scale-up
  • Purification process development and validation
  • Impurity profile analysis and release COA
  • Packaging
  • Analytical methods development and validation