All GMP-grade 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 adherence and have instituted
a continuous employee training program.
Process Development
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 synthesis, our process development team
will conduct following key activities:
Delivery of process development projects at all stages of clinical development
Process validation support
Support of delivery of manufacturing projects
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.
Supply Chain Auditing
SOPs for the handling and testing of raw materials have been developed and are strictly
followed.
Key features in our supply chain auditing include:
Purchasing power to access business leading suppliers for peptide processes.
Quality agreements for critical raw materials when required, with control of change.
Intimate knowledge for TSE / viral safety compliance with regulatory submission
needs.
Extensive database of vendors / suppliers.
Expertise and knowledge of industry IP positions.
Supplier visits farther down our supply chain to review.
Standards for ourselves, quality audited as required.
Key understanding of various peptide synthesis chemistry through internal experience.
Ability to utilise customer-supplied specialty materials, developing robust supply
chains for future supply management.
Materials inward storage, testing and control systems.
GMP Contract Manufacturing
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).