cGMP Peptide Synthesis
With more than a decade of committed service to the peptide industry, CPC is a trusted provider of high-quality peptides to researchers and pharmaceutical companies all over the world. The CPC Group is comprised of peptide experts who have actively pursued peptide design and large scale manufacturing for more than 30 years, so your project is in good hands. CPC is the ideal peptide partner from concept to commercial for all of your cGMP needs.
Extensive knowledge developed through years of experience in the peptide industry is at your disposal.
- SPPS, LPPS, ligation chemistry and fragment condensation methodologies
- All protecting strategies (Boc, Fmoc, Cbz) can be used
- Innovative purification and Lyophilization techniques employed
- Process development and scale-up competence insures a robust commercial process
- Complex sequences and peptide modifications adapted to large-scale production
HIGH-CAPACITY cGMP FACILITY
CPC is expanding our manufacturing facility to better support your cGMP needs.
- 70,000m² currently in operation
- 20,000m² expansion in build out (Commission planned April 2015)
- GMP batch sizes from gram scale to multi-kilogram scale
- Qualified air and water systems
- IQ, OQ, PQ qualified equipment
- Class C and D clean rooms
FULLY EQUIPPED LABORATORIES
CPC has an extensive portfolio of manufacturing equipment installed and qualified to produce cGMP-grade peptides in every stage.
- Reactors with multiple volumes (Maximum 1000L)
- Hybrid synthesis reactor
- Preparative HPLC systems with multiple flow rates
- Chromatography columns with various inner diameters (up to 20 in)
- Fast protein liquid chromatography (FPLC) systems
- Blenders and evaporators
- Manifold lyophilizers
- Tray lyophilizers
A dedicated Quality department verifies full cGMP compliance throughout production, as well as testing and documentation standards in accordance with the most stringent FDA requirements.
- In-process, release and environmental control testing performed
- Standard release testing performed in-house
- Audited contract laboratories available for additional testing
- Method development and validation, formal method transfer
- Stability studies (ICH) and forced degradation
- Process development support (peak homogeneity, impurity characterization)
A typical cGMP peptide is tested at CPC using the following methods:
Additionally, our QC department is fully equipped and additional analysis can be performed upon request.
- Counter-ion content
- Moisture content (Karl Fisher)
- Purity (HPLC, UPLC)
- Residual solvents
- Molecular weight (MS)
- Peptide content
- Heavy metal, ion exchange, CHN
CPC provides complete support for your IND and NDA filings in the USA as well as all international filings and all required regulatory support for your peptide APIs.
- Batch record review
- Complaint management
- Document management and control
- CAPA follow up and tracking
- Product release
- Phase appropriate control systems consulting
- CMC compilation
- DMF compilation and submission
- Annual product reviews
GENERIC PEPTIDE APIs AVAILABLE OR IN DEVELOPMENT
- Leuprorelin acetate
- Triptorelin acetate
- Exenatide acetate
- Terlipressin acetate
We will work closely with you throughout the project and adopt any previous chemistries that can shorten your clinical trials and reduce the risks in clinical filing complications.
- Project tracking
- Liaison to CPC operation
- Cross-functional links from CPC operation to customer operation
- Project history documentation
- Customer-centric collaboration
The satisfaction of our customers is the most important reason for our continued growth and success. One critical ingredient is maintaining the confidentiality of trade secrets and proprietary information released to us by our customers. CPC will assure the complete confidentiality of all proprietary information we receive during the course of fulfilling any of our custom services.