Production Process
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). |
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