We specialize in synthetic manufacturing of bioequivalent and biosimilar peptides traditionally manufactured by rDNA techniques. Our in-depth know-how on controlling the various peptide related impurities such as deletion, addition, deamidation, oxidation, and enantiomers allows us to manufacture synthetic peptides with extremely low-level impurity profiles. A very tight impurity control in the synthetic peptides is extremely important for the quick regulatory approval of the synthetic peptide drug products globally.
Microsphere delivery enables sustained and controlled release of peptide drugs providing increased stability, decreased side-effects, and the potential for weekly and once-monthly dosing. Our formulation expertise in combination with peptide know-how helps in developing long-acting stable formulations. We use Quality by Design (QBD) principles for all our development work which helps in smooth transitioning of the lab scale process to the commercial manufacturing site.
Our team of experts pioneer in the comprehensive characterization of the complex peptides. We have in-depth knowledge of advanced analytical techniques that are necessary to establish various physiochemical and biological attributes of the peptide molecule. We develop robust, sensitive, and selective analytical methods to thoroughly characterize our peptide molecules. Such methods are extremely important in ensuring that our peptide drug meets the stringent impurity, aggregation, and immunogenicity requirements. Thorough characterization of the synthetic peptides is a key to fast pace regulatory approval and commercialization of the peptide drugs.