Enhanced Diagnostic Tools
All GMP-grade Custom peptide synthesis manufacturing is performed in strict compliance with ICH Q7A
Good Manufacturing Practices for APIs, -CFR Part 210, 211 & 820 and EudraLex
Volume 4, Part II.. We pay close attention to compliance adherence and have instituted
a continuous employee training program.
The objective of our Process Development team at BSI is to provide efficient, robust
and scalable processes that can be used for clinical manufacture, process validation
and beyond. Before we start the large-scale peptide synthesis, our process development team
will conduct following key activities:
Development activities rely heavily on Design of Experiments (DoE). This can be
described as a structured, organized method for determining the relationship between
factors affecting a process.
SOPs for the handling and testing of raw materials have been developed and are strictly
Once a manufacturing process has been validated and approved, and no additional
GMP Custom Development is required, the production of the peptide becomes one of
contract manufacturing. Depending on the requirements for the peptide, the process
may be transferred to a manufacturing suite dedicated specifically to the peptide
API (active pharmaceutical ingredient).