PolyPeptide Laboratories has the experience, facilities, staff and track record to support your project throughout the highly regulated development and production process.
As your professional peptide partner, we maintain Regulatory Affairs departments in both the United States and Europe to address issues affecting your product in specific countries as well as globally. International harmonization of our Quality Assurance and Regulatory Affairs departments ensure that your NCE can be compiled and filed with full compliance at all international locations.
Among our accomplishments, we are proud to have participated in the approval of 20 Active Pharmaceutical Ingredients (APIs) worldwide. The PolyPeptide Laboratories Group has successfully undergone 8 FDA Pre-approval and Site inspections.
Among our many resources and services:
- FDA-compliant cGMP facilities
- Chemistry, Manufacturing and Controls (CMC) Documentation in Common Technical Document (CTD) format for INDs
- Drug Master File (DMF) Compilation
- Representation at the FDA and/or other Regulatory Authorities
GMP Services Included
GMP manufacturing requires considerable documentation and regulatory support. All GMP peptide projects at PolyPeptide Laboratories include a complete “price included” service package. This covers all the services needed to reach approval of your API.
We are an active partner in your project's success.
Our GMP Service Package includes:
- All GMP manufacturing procedures
- Preparation and characterization of an in-house reference standard
- In-house impurity reference samples
- Analytical development and characterization
- Analytical validation
- Full stability testing according to ICH guidelines (over 4 years at storage temperature)
- Process validation
- All batch documentation and any support documentation required, including a CMC/IND package and a US or European DMF as needed
- Support with regulatory agencies
All services will be performed at the appropriate stage of the project.
Our Standard GMP Specifications include:
- Appearance
- Solubility
- Identity (via mass spectral analysis, amino acid analysis and HPLC)
- Peptide purity (HPLC)
- Related substances (HPLC)
- Assay (peptide content)
- Bacterial endotoxins
- Counterion content
- Water
- Mass balance
- Specific rotation
- Residual organic solvents
We can add or make changes to specifications based on your specific requests.
