Starting material quality is critical for the final API quality. For the synthesis of therapeutic peptides, the normal proteinogenic Fmoc amino acid derivatives are readily available as starting materials in excellent quality. However, this is not necessarily the case for unnatural amino acid derivatives that are not routinely produced in large quantities. In addition to material quality, other aspects such as vendor sustainability, manufacturing capability, lead times, etc. are also important. Hence, just going for the highest material purity is not the best idea and analytical testing is not sufficient to select the material of choice.
A case study will be presented for the evaluation and selection of manufacturers for unnatural amino acid derivatives. Starting materials from different manufacturers will be compared based on their impurity profiles and the results in a product specific use test, covering all stages of the manufacturing process. Critical impurities are distinguished from non-critical impurities based on their potential to generate API impurities that cannot be purged during the peptide manufacturing process.
The live version of this recording took place on March 1, 2021 and features
a presentation by Tobias Kapp, Ph.D. &
Heiko Rinderhagen, Ph.D.
Who should participate:
- Analytical chemists
- QA/QC analysts
- R&D scientists, managers
- Team members in CMC development projects
- Manufacturing scientists, managers
- Regulatory affairs specialists
- Contract research organizations
- Contract manufacturing organizations
Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.