CordenPharma, headquartered in Germany, has expanded its new overseas commercial oligonucleotide API manufacturing capabilities at its FDA inspected CordenPharma Colorado (Boulder, Colorado, US) facility. The company provides pharmaceutical services and is a contract developer and manufacturer of APIs, drug products and associated packaging services. It has a growing network of cGMP facilities across Europe and the US.
Dr Matthieu Giraud, director of global peptides, oligonucleotides, lipids and carbohydrates platform, said: "This expansion will not only provide our customers timely and much needed oligonucleotide API manufacturing services to advance their drug development programmes in clinical trials as planned, but also allow them to leverage our regulatory expertise for scale-up and manufacture of commercial products.”
"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,” he commented.
The expansion, which was completed in Q1 2018, will provide cGMP oligonucleotide manufacturing capacity up to 2 mol, with a significant increase in total commercial capacity up to 500 kg annually, making CordenPharma Colorado one of the largest oligonucleotide manufacturing sites worldwide.
Brian McCudden, MD, president and CEO at CordenPharma Boulder and CordenPharma Colorado, commented: “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.”
