KATHRYN L. ACKLEY
Oligonucleotide CMC Consultant, USA
Member of Chemistry Today – Chimica Oggi Scientific Advisory board

Abstract

The number of oligonucleotide therapeutics in development continues to increase and so does the demand for oligonucleotide contract manufacturing services. Selecting the contract development and manufacturing organization (CDMO) best suited to manufacture a particular oligonucleotide is critical to the overall success of the drug development program. In this article, a stepwise process that can be used to select an oligonucleotide CDMO will be discussed.

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 ...