cGMP at CPC Scientific Inc.
CPC manufactures GMP grade peptides under strict adherence to FDA 21 CFR parts 210 & 211 and conforms to ICH Q7A Good Manufacturing Practices.
Quality Assurance and Regulations
cGMP manufacturing facilities, procedures, and documentation are maintained in accordance with current Good Manufacturing Practice as described in the United States Code of Federal Regulations. Starting raw materials vendors are carefully evaluated by our QA department and must provide a BSE free certificate. We provide complete support for your IND and NDA fillings whether they are documentation or experienced QA staffs.
Facilities and Production Capacities
- 4 independent production units
- Capacity in solid phase with 10 liter, 30 liters and up to 200 Liters
- PURIFICATION AND LYOPHILIZATION are performed inside Clean Rooms
- Clean Rooms are specifically designed with their own air system at class of 100,000, 10,000, 100
We welcome any of our customers to inspect or audit our cGMP facilities. To inquire about our GMP service, please contact us for details.
A dedicated QA/QC department guarantees full cGMP compliance throughout production, as well as testing and documentation standards in accordance with the strictest FDA requirements. CPC has developed and maintained a robust quality assurance system covering all aspects required for the cGMP production of peptide API�s. Customers� audits can be conducted whenever they deem necessary.
Continued regulatory assistance is provided by CPC throughout any project to make sure that our developments fit with the customers' requirements. This includes timely filing and updates of DMFs or CMCs as required.
A typical non-USP or EP grade GMP peptide is tested in CPC with following specifications:
- Purity by gradient HPLC
- Molecular Weight by ESI-MS
- Peptide content
- Counter ion content
- Water content
- Residual organic solvent content
Additionally, our QC department is fully equipped and capable of performing other requests such as stability, Bioburden test; Specific Rotation etc. Chemistry Process.
CPC has produced several tens of thousands peptides, and within those peptides, our peptide scientists have garnered skills in all peptide chemistry fields, except radio-labeling modification. CPC possesses the capabilities of t-Boc, Fmoc, Cbz, solid phase synthesis, solution phase synthesis, fragment condensation as well as ligation chemistries. With our experience and technical capacity, we can quickly scale up to gram or kilogram levels. However, peptide synthesis is just a portion of your successful clinical trial. 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.
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.