To ensure quality and precision in peptide development, we follow key strategies to achieve the best results. We begin with process research - feasibility, familiarization, and optimization - to establish the critical process parameters (CPP) and critical quality attributes (CQA).
Synthetic route scouting
With drug development and manufacturing processes becoming more complex, alternative synthetic route design is a critical step where existing methods are impractical for large-scale production. Synthetic route scouting brings together several disciplines, including medicinal, synthetic, and preparative chemistry. We thoroughly explore all aspects of your drug’s chemistry and understand what happens at each step of the route before any step is combined and an alternate, shorter route can be designed.
Impurity profiling
We have a highly skilled and experienced team of scientists who specialize in detecting impurities in peptides, even at low levels. Our comprehensive services include:
- residual solvent analysis,
- evaluation of process-related impurities,
- forced degradation and stability studies,
- assessment of genotoxic impurity levels.
Stability studies
Neuland has significant expertise in conducting stability studies that determine the shelf life and storage conditions of a product, ensuring its safety and efficacy. We closely monitor the quality of peptides under different conditions and time periods. By analyzing the data and purity over time, we can assess the stability of the product.
In cases where there are no reference standards, Neuland offers a range of analytical tests to identify and characterize the new material. These tests can detect impurities and their quantities, as well as the presence of atmospheric water or residual solvents from the manufacturing process.