Integrated late-stage evolution towards a lipidated peptide
The evolution towards a lipidated peptide can markedly reduce doses required to achieve the same efficacy.
A Copexis Case Study
Formulation improvements for intravenously administered drugs can be difficult and complex.
Case Study: Late stage development
Copexis proposed and managed the evolution towards a lipidated peptide that markedly increased the half-life thereby reducing markedly the doses required to achieve the same efficacy.
This change induced marked investments at this stage of development that were largely balanced by the reduction of the costs of goods and by the fact that the proof of concept was already done.
The development impact of this change could be limited, in agreement with the regulatory authorities, by appropriate use of the manufacturing, toxicology and clinical data generated with the nude peptide.
Copexis is a quality-driven consultancy which distinguishes itself with its ability to offer fully integrated drug development consulting services.
For more information on formulation improvements please contact COPEXIS today.
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