RENAN RAVETTI DURAN, OLIVIER LUDEMANN-HOMBOURGER
PolyPeptide Group, Strasbourg, France

Abstract

The peptide market sees broadening indications, innovative development approaches and new formulations strategies, in some instances resulting in a significant increase of the manufactured batch size. This results in a challenge to adapt the available manufacturing infrastructure for cost-effective, flexible and sustainable solutions.
In this paper we will discuss about the scale-up aspects, process development efforts and how this impact the selection and optimization of the process. We will also see how PolyPeptide Group is adapting its manufacturing practices to meet the challenges and the market needs by promoting the greenest solutions for peptide manufacturing.

PEPTIDES MARKET
Peptide drugs have over the last decades been a growing market thanks to their safety profiles and attractive pharmacological mechanisms of action, which can be exploited for efficient treatments of various diseases. Currently, more than 80 peptides drugs are on the global market, peptides are used in more than 150 clinical trials, and around 500 peptides are in preclinical development (1).

Administration of peptide-based drugs was historically based on subcutaneous injection, due to their physicochemical characteristics. The challenges to apply oral formulation to peptides is well known, due to a low gastric stability (proteolytic digestion), a poor intestinal permeability and rapid systemic metabolism. Nevertheless, new delivery strategies are emerging over the last years, opening new opportunities to further extend the market interest for therapeutic peptides.
The consequence of the new formulation strategies, combined with the development of increasingly complex peptide sequences (including non-natural and non-amino acid motifs) is generating increasing pressure to produce the peptide in an economical and ...