8:00am | Workshop A
Dynamic Journeys: Defining CQA for Oligonucleotide Therapeutics
Synopsis
In this session embark on an exploration of how CQAs serve as the linchpin, influencing the quality of the final products. Navigate case-studies and unique experiences for hands-on development. Delving into the additional CMC considerations that demand from regulatory compliance to manufacturing scalability, you will unravel the complex landscape of CMC with precision and clarity.
Join this workshop as we delve into:
- Highlighting essential steps and emphasising crucial considerations when deciding CQA
- Additional CMC considerations needing to be addressed
- Identifying assays and the challenges without reference standards, and additional practical implication
10:30 am Morning Break
11:00am | Workshop B
Breaking Boundaries: Innovative Analytical Development for Oligonucleotide-Conjugates
Synopsis
How can we ensure high quality oligonucleotide products are produced as we increase chemistry complexities?
This workshop will convene experts to discuss:
- Discussing other factors of consideration: impurity profile, linkers and conjugation moieties
- Examining conjugation site analysis and heterogeneities and what methods and equipment can bridge the gap from more traditional oligos
- Quantifying conjugation and exploring detection methods
1:30 pm Lunch
2:30pm | Workshop C
Scaling New Heights: Establishing a Robust Control Strategy for Oligonucleotide Drug Development
Synopsis
Take a hands-on perspective on the scale-dependent nuances of oligonucleotide production, engaging in lively debates surrounding factors such as impurities. With a keen eye towards innovation and a commitment to excellence, dissect the challenges posed by scale and uncover strategies to mitigate their impact on product integrity.
This workshop will gather experts to discuss:
- Ensuring process stability and controlled variables to ensure consistent product quality
- Debating scale-dependant factors such as impurities