Peptide Production Process
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:
- 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
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
- Extensive database of vendors / suppliers.
- Expertise and knowledge of industry IP positions.
- Supplier visits farther down our supply chain to review.
- Standards for BSI, quality audited as required.
- Key understanding of various peptide synthesis chemistry through internal experience.
- Ability to utilize customer-supplied specialty materials, developing robust supply
chains for future supply management.
- Materials inward storage, testing and control systems.