cGMP peptides
Selleck cGMP facilities are designed for large-scale manufacturing of pharmaceutical drug substances for clinical research. Manufacturing under cGMP is performed under strict adherence.
- Technology Platform
- Raw material qualification
- Synthetic method development
- Synthetic method validation
- Synthetic method scale up
- Product Purification
- GMP/GLP analytic method development
- GMP/GLP analytic method validation
- Release specification design
- Release specification testing
- Stability testing(if needed)
- GMP packaging
- GMP compliance documentation
- GMP compliance
- On-going training
- In-house Audit
- Raw material control
- Analytical method validation
- Analytical method documentation
- SOPs
- In process control and batch record
- Equipments
- Computers
- Certificate of Analysis
- 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
- 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