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