How to Select a Therapeutic Oligonucleotide CDMO

Oligonucleotide therapeutics have become an established drug platform. Sixteen oligonucleotide drugs are now approved, and hundreds more are in development. As the number of approved drugs has increased, so has the demand for oligonucleotide contract manufacturing services. The barrier to enter therapeutic oligonucleotide manufacturing is high. The standard manufacturing process requires a significant investment in specialized equipment and a facility that can safely accommodate large quantities of hazardous solvents and chemical waste. For this reason, many drug sponsors seek out the services of CDMOs rather than developing internal manufacturing capacity.

Currently there are approximately twenty CDMOs that advertise the capability to manufacture therapeutic oligonucleotides. Each CDMO varies in experience, capabilities, capacity, and ancillary services offered. The newest CDMOs may have just a year of experience manufacturing oligonucleotides, and the most experienced CDMO has been manufacturing oligonucleotides for over two decades. Drug sponsors need to establish a systematic process to evaluate potential CDMO partners and identify the CDMO best suited for their programs.