The expansion, which was completed in the first quarter of 2018, will provide cGMP oligonucleotide manufacturing capacity up to 2mol, with a significant increase in total commercial capacity up to 500kg annually, making CordenPharma Colorado one the largest oligonucleotide manufacturing sites worldwide. The facility has not only enhanced capacity, but also put in place a dedicated team of experts with more than 20 years of experience in manufacturing oligonucleotides.
"This expansion will not only provide our customers timely and much needed oligonucleotide API manufacturing services to advance their drug development programs in clinical trials as planned, but also allow them to leverage our regulatory expertise for scale-up and manufacture of commercial products," said Matthieu Giraud, director, global peptides, oligonucleotides, lipids and carbohydrates platform, CordenPharma. "Drawing upon our strong history in highly potent peptide API manufacturing, CordenPharma Colorado's engineers implemented an innovative design to ensure low endotoxin / bioburden levels, which are a prerequisite for injectable APIs."
Brian McCudden, managing director, president and chief executive officer, CordenPharma Boulder and CordenPharma Colorado, said, "The oligonucleotide expansion marks another important milestone in our strategic plan to offer comprehensive development and manufacturing API services. We now offer GMP manufacturing at multiple scales to leverage a seamless technology transfer process from our experienced oligo development team."