A well-designed chemistry, manufacturing and control (CMC) strategy is essential when developing oligonucleotide therapeutics. This webinar examines potential CMC gaps occurring through research to commercial stages, helping to improve project design and management from a CMC perspective.
Oligonucleotide development and manufacturing requires many particular capabilities, from specialized manufacturing centers and equipment to process and analytical methodology development, as well as technical expertise. For this reason, oligonucleotide manufacturers play a crucial role as a partner to support a client’s project from early drug development to commercial manufacturing. However, one usually needs to change oligonucleotide CDMO partners when moving from the research and discovery stage to preclinical/clinical stage as well as to the commercial stage.
CDMOs/CROs/CMOs at each of these stages will have different business models, and, therefore, they prioritize different aspects of the development and/or manufacturing stage. For example, in the discovery stage, the priority would be high-throughput and purity of the target oligonucleotide, while in the clinical stage, the focus would be on prioritizing reliability, reproducibility and impurity control towards the commercial stage.
The difference in priorities and focus at the different stages can cause large gaps between early-stage and late-stage development, and a rough transition between them.
In this webinar, Hideyuki Tanaka, Senior Director, Business Development, Ajinomoto Bio-Pharma Services, discusses these concerns and examines the necessary development and manufacturing expertise required to seamlessly transition from the research to commercial stages, in order to close the gaps, thus building a bridge to ensure the client’s project runs smoothly from the early to late stage of development.