Peptide APIs
At Cerata Pharmaceuticals LLP, the production of Peptide Active Pharmaceutical Ingredients (APIs) combines precision chemistry, advanced technology, and rigorous quality systems to ensure consistent, high-purity peptide manufacturing for global markets.
Peptide Synthesis Technology & Process
Peptide synthesis begins with protected amino acids or specialized peptide fragments, which are sequentially assembled using solid-phase peptide synthesis (SPPS) to construct complex peptide chains with exact sequence fidelity.
Solid-phase peptide synthesis (SPPS)
Sequential assembly using protected amino acids or specialized peptide fragments
Controlled elongation & deprotection
Precise construction of complex peptide chains
Reduced side reactions
Minimized intermediate degradation during synthesis
Exact sequence fidelity
Ensured structural integrity of peptide chains
Manufacturing Infrastructure & Scale
Our manufacturing processes integrate advanced equipment and controlled environments to support reproducible peptide production from development through commercial supply.
Automated peptide synthesizers
High-precision automated systems for reproducible synthesis
High-capacity reaction systems
Scalable reactors for commercial-scale production
Lyophilization systems
Freeze-drying technology for stable peptide APIs
Controlled environments
Specialized suites for potent molecule handling
Process Development & R&D Support
The development of each peptide is supported by a dedicated R&D team focused on process optimization, scalability, and commercial readiness.
Protective group strategy design
Customized protection schemes for complex peptides
Yield and reproducibility enhancement
Statistical optimization for maximum efficiency
Process optimization and scale-up
Seamless transition from lab to commercial scale
Technology transfer to manufacturing
Comprehensive knowledge transfer and implementation
Quality Control & Analytical Excellence
Quality control is implemented at every stage of peptide API manufacturing, ensuring purity, identity, and batch-to-batch consistency.
Analytical Methods
- In-process monitoring and intermediate testing
- High-resolution HPLC analysis
- Mass spectrometry and peptide-specific assays
- Final API validation and release testing
Quality Assurance
- Batch-to-batch consistency verification
- Peptide-specific assay validation
- Purity and identity confirmation
- Stability testing and shelf-life determination
Quality Systems & Compliance
High-containment production lines and a robust Quality Management System ensure regulatory compliance, product integrity, and reliable global supply.
WHO-GMP Alignment
Manufacturing systems meeting global GMP standards
- Controlled environments
- Documentation systems
- Audit readiness
ISO 9001:2015
Certified Quality Management System
- Process optimization
- Continuous improvement
- Risk management
Regulatory Compliance
Regulatory-ready documentation and traceability
- Electronic batch records
- Full traceability
- Global regulatory support
Global Leadership in Peptide API Manufacturing
With this integrated approach, Cerata Pharmaceuticals LLP delivers high-quality, therapeutically active Peptide APIs trusted by pharmaceutical and biotech companies worldwide.