The Frankfurt, Germany facility will add over 10,000 square feet of manufacturing space. The facility will include two fully equipped lines comprising a solid phase peptide synthesizer (SPPS), high pressure liquid chromatography (HPLC), liquid Phase (LP), isolation equipment and quality control laboratories including in process control (IPC), starting material batch release, and good manufacturing practice (GMP) stabilities.
The site is designed to produce peptide active pharmaceutical ingredients (APIs) from gram to kilogram range for clinical Phase I and II requirements. Additionally, it will support the transfer to the CDMO’s Colorado, US site for late phase and commercial manufacturing.
APIs are used to treat various diseases such as metabolic disorders, tumors, cardiovascular and cardiac diseases, and neurodegenerative disorders.
“With our new early clinical GMP peptide manufacturing investment in Frankfurt and the launch of seamlessly integrated peptide API to injectable drug product services, CordenPharma is uniquely positioned to deliver customized CMC support for biotech customers and facilitate their successful IND/IMPD submissions and start of FIH clinical trials,” said Stéphane Varray, global peptide platform director, CordenPharma.
"We believe the offer will bring added-value and increased efficiency to our customers, and ultimately enhance the well-being of their patients.”
According to the CDMO, the expansion offers integrated services between the Frankfurt facility (for peptide drug substance) and Caponago, Italy site (for injectable drug products). The aim is to deliver fully customizable technical, manufacturing, and regulatory support that is specifically targeted to enable efficient investigational new drug (IND) filings, with all the necessary materials needed to initiate customers’ first in-human (FIH) clinical trials.
The facility is expected to be fully operational in Q2 2024.
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