This webinar will examine potential CMC gaps that can occur between research and commercial stages, helping to improve project design and management.
TORONTO (PRWEB) January 13, 2021
A well-designed chemistry, manufacturing and control (CMC) strategy is essential when developing oligonucleotide therapeutics. This webinar will examine potential CMC gaps that can occur between research and commercial stages, helping to improve project design and management.
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, contract development and manufacturering organizations (CDMO), who specialize in oligonucleotides, play a crucial role in supporting a client’s program from early drug development to commercial manufacturing. However, sponsors typically change oligonucleotide 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.
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
In this webinar, Hideyuki Tanaka, Senior Director, Business Development, Ajinomoto Bio-Pharma Services, will examine the necessary development and manufacturing expertise required to seamlessly transition from the research to commercial stages, closing the gaps, and building a bridge to ensure the client’s project runs smoothly from early to late stages of development.
Register for this live webinar on Wednesday, January 27, 2021 at 11am EST (4pm GMT/UK) 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.
For more information, or to register for this event, visit Oligonucleotide Therapeutics: Bridging from Research to Commercial.
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