L-Cysteine Bulk Supply

GMP Peptide Manufacturing

GL Biochem manufactures GMP grade peptides under strict adherence to Good Manufacturing Practices.

GMP Peptide Technology Platform

• Raw material qualification
• Synthetic method development, validation and scale up
• Product Purification
• GMP/GLP analytic method development and validation
• Release specification design and testing
• Stability testing (if needed)
• GMP packaging
• GMP compliance documentation

GMP compliance

• On-going training
• In-house Audit
• Raw material control
• Analytical method validation and documentation
• SOPs
• In process control and batch record
• Equipments
• Computers

Certificate of Analysis for GMP Peptide

• Appearance
• Purity by HPLC
• Heavy metal by ICP-MS
• Bioburden or microbial tests
• Residual organic solvent by GC
• Solubility
• Molecular Weight by MS
• Amino acid analysis
• Water content
• Endotoxin
• Amino acid analysis
• Peptide Content (nitrogen estimation)
• Counter Ion Content (% TFA) by IC

GMP Quality Management