Bachem, founded by Peter Grogg, initially focused on minor acid derivatives before specializing in synthetic peptides and solid phase peptide synthesis. Over time, the company expanded into oligonucleotides due to their similarities with peptides, leveraging over 50 years of accumulated knowledge to meet market demands.
Bachem places a strong emphasis on quality, limits, guidance, and speed in their processes, including the analytical part, to cope with market demands. Peptide aggregation is a critical issue for Bachem, as it impacts patient safety and drug efficiency, and must be managed during the manufacturing process.
Downstream process development is crucial to avoid aggregation, ensuring high-quality material and optimizing manufacturing steps. Bachem employs various analytical methods, such as visual inspection, light scattering instruments, and SEC, to monitor and manage aggregation.
Detecting aggregation involves understanding the limitations of analytical instruments and ensuring meaningful results, often requiring kinetic studies. Early detection of aggregation tendencies during process development is essential to avoid issues during upscale or further project development.
Each peptide requires individual analysis to ensure stability and avoid inducing aggregation, highlighting the importance of tailored downstream processes and good analytical techniques.