cGMP Peptide Production Seminar
CEM recently hosted a luncheon seminar at the 10th International Peptide Symposium on December 5th. During this seminar, Life Science Global Product Manager Michael Karney presented new standardized chemistry and technology that encompasses GMP peptide production from mg to kg scale. To validate this comprehensive and simple strategy that utilizes microwave heating and rapid automation, a variety of peptides from current literature were synthesized. Key features of this methodology include:
- Increased purity and suppressed side reactions such as epimerization as compared to conventional methods
- Robust, simple synthetic parameters for both standard and non-standard (cyclic, branched, stapled, etc.) sequences
- One-pot coupling and deprotection process for increased efficiency
- Reduction of up to 95% generated waste compared to conventional methods
Rapid scale-up for clinical trials and peptide production has been accomplished using similar technology with a focus on elevated temperatures. Crude purity from R&D to production scale is preserved if not improved and unwanted side reactions such as epimerization and aspartimide formation are easily controlled. The result, easier purification and reduced labor cost. Cycle times at the production scale range from 10 – 60 min with the capability to produce up to 1 kg crude peptide in a single batch. Several examples, including process development, were presented.
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