The expansion, which was completed in Q1 2018, will provide cGMP oligonucleotide manufacturing capacity up to 2mol, with an increase in total commercial capacity up to 500kg annually. 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,” Dr. Matthieu Giraud, Director, Global Peptides, Oligonucleotides, Lipids & Carbohydrates Platform said. “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.”