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Our Custom peptide 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 standards and have instituted an ongoing 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