Oligonucleotides are chemically synthesized short nucleic acid polymers designed to fuse with DNA or ribonucleic acid (RNA) sequences. They can be used to treat infectious, and genetic diseases, as well as some cancers.
The CDMO’s capacity expansion – which was completed in Q1, 2018 – “primarily relates to the synthesis, but also includes purification and concentration,” explained CEO of CordenPharma Boulder and Colorado Brian McCudden.
The investment “will not only provide our customers timely and much needed oligonucleotide active pharmaceutical ingredient (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,” said Dr. Matthieu Giraud, director, global peptides, oligonucleotides, lipids and carbohydrates platform.
McCudden added that the firm has observed growing demand for oligonucleotide APIs in the clinical space – both in early and late phase development.
The increased capacity will positively impact the firm’s headcount, he told us: “We are increasing our staffing to accommodate the expansion.”
The expansion follows on from a number of facility investments for the CDMO last year.
In September 2017, CordenPharma completed its early development suite for highly potent, oral solid dosage products at its facility in Plankstadt, Germany.
The following month, the CDMO bought an ex-Hospira API plant in Colardo from Pfizer – which it will take over by the end of 2019 – and announced plans to increase its small molecule development services at its site in Liestal, Switzerland.