Quality Controls and Assurance
Our quality processes and management are paramount at every step of development and production. At the start of each GMP peptide project, robust and discriminatory analytical methods are developed. Rigorous analytical characterization is conducted for the development of a robust manufacturing process to ensure the quality of the API.
BSI has produced several tens of thousands of peptides, and within those peptides, our peptide scientists have acquired diverse skills in all peptide chemistry fields. 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. Our commitment to our client is to provide regulatory assistance thoughout any project and to make sure our developments fit with the customer's requirements.
This includes timely filing and updates of DMFs or CMCs, as required.
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A typical GMP peptide is tested in BSI with following specifications:
- Mass Spectral Analysis
- Amino Acid Analysis (AAA)
- Sequencing
- RP-HPLC
- Residual Organic Volatiles
- Bacterial Endotoxin Evaluation
- Bioburden Evaluation
- Net Peptide Content by AAA
- Counter Ion Content (Acetate, Trifluoroacetate, Hydrochloride, etc.)
- Secondary Counter Ion Content
- Water Content
- Mass Balance Calculation
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