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Peptides
GMP Peptide Manufacturing
Custom Peptide Synthesis
To provide you with quality peptide product for the results you can trust...
GMP Peptide Manufacturing
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 throughout 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.
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