cGMP Peptide Synthesis
Pharmaceutical-grade peptide manufacturing in fully validated cGMP facilities for IND, clinical, and commercial supply.
Service Overview
SynthAxis operates purpose-built cGMP peptide synthesis suites compliant with ICH Q7 guidelines. Our platform supports therapeutic peptide APIs from early-stage IND enabling batches through Phase I–III clinical supply and commercial manufacturing.
We employ automated SPPS platforms with advanced orthogonal protection strategies, high-resolution reversed-phase HPLC purification, and comprehensive analytical packages including identity confirmation, purity determination, residual solvent testing, and microbiological analysis.
Every cGMP batch is supported by a complete batch manufacturing record (BMR), certificate of analysis (COA), and full regulatory documentation package to support your submission requirements.