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 will discuss these concerns and examine 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.
These gaps between the research and clinical stages can be summarized into four distinct categories:
- Oligo synthesizer differences
- Required timelines
- Quality considerations and appropriate analytical method development
- Manufacturing method and optimization
Register for this webinar to learn about the impact of each of these gaps and how to overcome them. Learn from Ajinomoto Bio-Pharma Services’ more than 20 years of focused experience and application in oligonucleotide development and manufacturing.
Hideyuki Tanaka, Senior Director, Business Development, Ajinomoto Bio-Pharma Services, United States
Hideyuki Tanaka is the Senior Director of Business Development at Ajinomoto Bio-Pharma Services in San Diego, CA. He is responsible for business development activities of drug substance and oligo drug products for the North American market.
Hideyuki holds a Master of Pharmaceutical Chemistry degree and an MBA from Bond University in Australia. Hideyuki has 20 years of experience in the pharmaceutical and CDMO industries, previously holding roles with corporate governance, coordination, project management and medicinal chemistry.Message Presenter
Who Should Attend?
- Drug Development Teams
- R&D Teams
- Project Managers
- Manufacturing and Operations Teams
- Drug Developers
- Drug Discovery Teams
- Protein and Peptide Chemists
- CSO, CEO
- Formulation and Applications Chemists
What You Will Learn
- Key steps for characterizing and overcoming the gaps at each development stage
- How to bridge the gap between discovery and the preclinical/clinical stage
- Necessary development & manufacturing considerations for a smooth tech transfer
Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India, providing comprehensive development, cGMP manufacturing, and aseptic fill finish services for small and large molecule APIs and intermediates. Ajinomoto Bio-Pharma Services offers a broad range of innovative platforms and capabilities for pre-clinical and pilot programs to commercial quantities, including Corynex® protein expression technology, oligonucleotide synthesis, antibody drug conjugations (ADC), high potency APIs (HPAPI), biocatalysis, continuous flow manufacturing and more. Ajinomoto Bio-Pharma Services is dedicated to providing a high level of quality and service to meet our client’s needs.