Traditionally, molecules between 2 and 50 aminoacids are considered as peptides, whereas proteins are made up of more than 50 aminoacids.
So, peptides represent a unique class of pharmaceutical compounds, molecularly positioned between small molecules and proteins, yet biochemically and therapeutically distinct from both.
Peptide therapeutics can be produced biosynthetically via natural or recombinant microbial fermentation or chemically through a mechanism such as solution-based or solid-phase peptide synthesis. Its use has had a great expansion in recent years for the treatment of diabetes, cancer and cardiovascular disease.
Due to the rapid growth in its use and the necessary appearance of new specific regulatory requirements ( ICH guideline Q6A) applicable to synthetic peptides of low molecular weight, AMSbiopharma has adopted the existing characterization methods for monoclonal antibodies (mAbs) and proteins, focusing specifically for each particular therapeutic peptide.
In this way, and always with a specific orientation to each client, AMSbiopharma offers the following analytical services applied to therapeutic peptides: