Experts in the chemical and pharmaceutical development of peptide-based drug products and finished products up to pharmaceutical certification

+ 15 years
<p>of experience as a peptide CDMO</p>
500 m<sup>2</sup>
<p>of GMP laboratories</p>Know how

<p><strong>From chemical conception to clinical batches</strong></p>
<ul> <li>Process development</li> <li>Analytical development</li> <li>Bulk or aliquoted technical batches</li> <li>Pre-formulation</li> <li>Manufacturing of API batches for tox studies</li> <li>Manufacturing of API batches for clinical studies</li> <li>Coordination of the manufacturing of finished products for clinical trials</li> <li>Pharmaceutical certification for EU clinical trials</li>
</ul>
Expertise

<ul> <li>Short peptides</li> <li>Complex peptides</li> <li>Long peptides (up to 150 mer)</li> <li>Conjugated peptides (KLH, CRM197, Fab, PEG)</li>
</ul>
The teams work alongside our customers to find innovative and adapted solutions that guarantee the success of their pharmaceutical manufacturing projects.
Production means

<ul> <li>Solid Surface Peptide Synthesis Platform (SPPS) for Process Development</li> <li>Analytical department for quality control and development of analytical methods for chemical and biological compounds</li> <li>Room dedicated to non-aseptic packaging of experimental batches</li>
</ul>

<ul> <li>GMP production plant in controlled atmosphere zone for API manufacturing <ul> <li>Synthesis / Cleavage</li> <li>Purification</li> <li>Lyophilization</li> <li>Sterilizing filtration</li> <li>Aliquoting under laminar flow</li> <li>Final lyophilization</li> </ul> </li> <li>Analytical department for quality control, Qualification / Validation of analytical methods for chemical and biological compounds</li> <li>Network of European partners for fill and finish activities: <ul> <li>Production of clinical batches in sterile environment</li> <li>Packaging in therapeutic units</li> <li>Pharmaceutical certification of batches for clinical trials</li> </ul> </li>
</ul>