cGMP Peptide Manufacturing
GMP Peptide Manufacturing
With diverse manufacturing suites, VCPBIO can produce large scale of peptide APIs. VCPBIO cGMP facilities are designed for large-scale manufacturing of pharmaceutical drug substances for clinical research. Manufacturing under cGMP is performed under strict adherence.
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
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