The oligonucleotide market is poised for high growth over the next few year driven by a few factors, including high application potential of oligonucleotides for a variety of medical conditions, a growing number of FDA approved oligonucleotide drugs, an increased focus on personalized medicine, and a continued emphasis on the development of therapeutics for rare diseases. As a result, contract development and manufacturing organizations (CDMOs) are seeing increasing requests for oligonucleotide production from small to commercial scale. The challenges to a CDMO partner is to cost-effectively, quickly and easily scale up your oligonucleotide from research to commercial quantities, as well as having the facilities in place to manage commercial scale quantities.
Noriyasu Kataoka, M.Sc., is the Quality Manager & President and Akihiro Oota is the General Manager of Oligonucleotide & GMP Manufacturing at the Osaka site of Ajinomoto Bio-Pharma Services (Aji Bio- Pharma), which recently constructed and opened a new Oligonucleotide API Manufacturing Center. The Osaka site has been successfully synthesizing oligonucleotides for research use for over 20 years prior to developing GMP manufacturing for oligonucleotides. In this Q&A, they discuss the resources and capabilities needed for a CDMO to seamlessly scale oligonucleotides from research to commercial manufacturing.