From Peptide Insolubility Challenges to Clinical Manufacturing Success

How Neuland developed an innovative synthesis strategy for a complex 25-amino-acid peptide, overcoming insolubility and impurity challenges to support clinical development

In this case study, discover how Neuland partnered with a European biotechnology company developing an osteoporosis therapy to design an entirely new manufacturing process for a 25AA peptide API. Despite having access only to the peptide sequence, Neuland successfully developed a scalable SPPS-based synthesis route, minimized impurity formation, resolved purification challenges, and delivered GMP material for clinical development.

Key Takeaways

• Developed a scalable synthesis route for a complex 25AA peptide API
• Successfully addressed peptide insolubility challenges
• Reduced impurity formation through an optimized SPPS process
• Enabled efficient purification using orthogonal preparative HPLC
• Produced GMP clinical-trial material with high purity
• Delivered over 120 g of API at >96% purity