7:30 am Check In & Light Breakfast
8:25 am Chair’s Opening Remarks
Investigating the Future of Oligonucleotide Drug Development
8:30 am Panel Discussion: Exploring Novel Oligonucleotide Drug Development: Unlocking New Opportunities, Overcoming Market Challenges & Advancing Innovative Oligos Through Pipelines
Synopsis
• Validating strengths and new opportunities that have emerged in the space
• Analyzing weaknesses and threats that oppose commercial market access
• Overview of different oligo modalities and their positioning in clinical development
Innovating Analytical Techniques for Impurity Profiling & Separation to Boost Yield, Ensure Safety & Maximize Efficacy
9:00 am Analytical Method Bridging for Denaturing HPLC: A Case Study in Oligonucleotide Purity
Synopsis
• Overview of the design and execution of bridging studies for denaturing HPLC methods
in oligo analysis
• Discussion of method optimization and laboratory transfer strategies to support
analytical continuity as oligonucleotide drugs progress through development and
manufacturing
• Presentation of case studies and best practises to ensure successful method bridging
and maintain analytical consistency
9:30 am Development & Implementation of a Phase Appropriate Impurity Characterization & Control Strategy for a GalNAc RNAi Therapeutic
Synopsis
- Analytical toolbox: Implementation of orthogonal methods for siRNA testing
- Identification and characterization of impurities under anion exchange HPLC and ion pairing reverse phase HPLC
- The practical aspects and the application of the methods for RNAi therapeutics impurity control
10:00 am Orthogonal Method Strategies for Oligo Impurity Profiling
Synopsis
• Exploring the source of oligo impurities and categorizing them effectively
• Considerations for oligo impurity profiling to meet regulatory expectations
• Case study: oligo impurity profile by orthogonal UV method and characterization by UV
10:30 am Speed Networking
Synopsis
This informal session provides the perfect opportunity to connect with industry pioneers and key
opinion leaders in the oligonucleotide therapeutics field. Establish meaningful connections to build
upon at the rest of the conference and gain exclusive first-hand insights into the latest research and
developments driving progress in the space.
11:00 am Morning Break
11:30 am A Manufacturing Solution for High Purity Long Oligonucleotides Products
12:00 pm Impurity Profiling of VO659, VICO’s Antisense Oligonucleotide for the Treatment of PolyQ Diseases
Synopsis
- Case study looking into VO659 antisense oligonucleotide which is in clinical trials for Huntington’s Disease, SCA1 and SCA3
- Utilizing LC-UV-MS for impurity profiling
- Qualifying levels of impurities in oligo drugs
12:30 pm Lunch & Networking Break
Advanced Analytical Solutions for Complex Oligos Modalities to Ensure Quality & Expedite Development
2:00 pm Analytical Strategies for Oligonucleotide Impurity Monitoring & Control in Oligonucleotide Conjugates
Synopsis
- Exploring the key challenges in the characterization and control of oligonucleotide protein transport vehicle (OTV) conjugates
- These challenges include the masking of protein charge variant profiles by the highly negative charge of the oligonucleotide and the fate and criticality of oligonucleotide impurities during conjugation
- Additionally, the unique considerations for residual payload assays compared to antibody-small molecule drug conjugates. Strategies for addressing these issues will be discussed
2:30 pm Afternoon Networking Break & Scientific Poster Session
Synopsis
Want to share your work but not ready for the big stage just yet? The Scientific Poster Session is
your prime time to share your work with peers from various backgrounds, all focused on analytical
development & CMC for oligonucleotide drugs. Gain feedback on how you can accelerate the
progression of your drug pipelines and build connections for potential collaborations to take your
therapeutic from clinic to market.
Optimizing Scalable GMP Complaint Manufacturing by Controlling Critical Process Parameters & Innovating Early-Stage Oligo Models
3:00 pm Critical Process Parameters in Oligonucleotide Manufacturing: Strategies for Control During Scale-Up
Synopsis
• Emphasizing the importance of early identification of Critical Process Parameters
(CPP) to enable effective control strategies that ensure consistent product quality and
compliance
• Developing robust and predictive down-scale models to accurately illustrate large scale
manufacturing and minimize risk of unexpected results during scale up
• Case studies highlighting the impact of insufficient CPP control: common pitfalls and
establishing effective control frameworks
3:30 pm Strategic Development and Technologies for Elevating the Quality of Oligonucleotides
Synopsis
- Overview of oligonucleotides
- Breakthrough advancements in Solid-Phase and Next-Generation synthesis technologies
- Innovations in downstream process development to enhance quality and maximize yield
- Asymchem’s unique capabilities and scalable capacity to drive CDMO partner success
4:30 pm Continuous Process Improvement: Limitations of an Early-Stage Manufacturing Process Addressed By Innovative Chemistry
Synopsis
• Due to some unique structural characteristics, appropriate process parameters were
developed for the first GMP delivery
• Cleavage and Deprotection conditions were carefully designed to generate material
meeting desired specifications
• A deeper understanding of the chemical process led to development of a robust protocol
that is amenable to large-scale synthesis using typical oligo plant equipment
5:00 pm Breakout Roundtable Discussions
Synopsis
Uncover the story behind leaps and setbacks from the movers and shakers of oligo analytical development & CMC. Each roundtable will be hosted by a leader in the space who will share a challenge, question or case study to discuss.
Round table 1: Integrating Novel Analytical Techniques into a GMP Compliant Lab
Round table 2: Utilising Software & Analytics to Improve Accuracy of Impurity Profiling & Separation
5:30 pm Chairs Closing Remarks & End of Conference Day One
5:30 pm Drinks Reception
Synopsis
After a day of insights, join us for an informal drinks reception. It’s the perfect chance to relax, network, and spark new conversations with industry peers.