Oligonucleotide Symposium: Solutions to Analytical Challenges, CMC Factors, and Compliance Considerations in Biopharmaceutical Manufacturing

This symposium will take you on a journey through the world of oligonucleotides. Beginning at preparation and manufacture, then on to analytical method development and optimization, before ending with regulatory and compliance considerations; our three experts will cover everything you need to know about these exciting, yet complex molecules.

Register Free: https://www.chromatographyonline.com/ca_w/oligos

Event Overview.

Therapeutic oligonucleotides (oligos) have emerged as an area of particular interest and promise in biopharmaceutical research because of their potential to treat a wide range of disease.

This half-day symposium will take you on a journey through the world of oligonucleotides. Beginning at preparation and manufacture, then on to analytical method development and optimization, before ending with regulatory and compliance considerations; our three experts will cover everything you need to know about these exciting, yet complex molecules.


Symposium Agenda

9:00am - 9:45am ET
Oligonucleotide Analysis in Biopharma Manufacturing: Method Development when Scaling up to Prep
Connor Flannery, Global Product Manager LC Biocolumns; Agilent

Therapeutic oligonucleotides have emerged as an area of promise in biopharmaceutical research because of their ability to target different biological pathways and treat a wide range of diseases. These oligos can range in size, sequence complexity, and overall modifications. As a result, the analysis and purification of oligonucleotides by liquid chromatography is critical and complex. In this presentation, we will discuss some of the unique chromatographic challenges that oligonucleotides present and discuss a simplified approach to method development optimization when scaling up from analytical characterization to preparative purification and manufacturing.


9:45am - 10:30am ET
Oligo Analytical Method Development Optimization to Species
Christina Vanhinsberg, Senior Scientist; AstraZeneca

In this presentation, we will discuss the oligonucleotide therapeutic landscape, how we utilize chromatography within the CMC-stability and release testing, process control, and the chromatographic techniques and detection method which can be employed for oligonucleotides and oligonucleotide drug products.


10:30am - 11:15am ETOligo/Nucleic Acid Regulatory and Compliance Considerations
Jared Auclair, Vice Provost Research Economic Development, Director of Bioinnovation; Northeastern University.

In this presentation, we will examine the regulatory considerations around oligo/nucleic acid regulatory processes, specifically related to CMC. Also, a discussion related to regulatory lessons learnt from the mRNA COVID vaccines will be discussed.

Speakers:

Connor Flannery
Global Product Manager LC Biocolumns
Agilent

Connor Flannery is a Global Product Manager for LC Biocolumns at Agilent Technologies. Prior to his work in product management, he worked as a R&D Product Development Chemist. His work focused on the development and characterization of novel stationary phases for targeted LC applications, and high-pressure column-packing technologies.

Christina Vanhinsbergh
Senior Scientist
AstraZeneca

Dr. Christina Vanhinsbergh is a senior scientist at AstraZeneca working in the analytical team for oligonucleotide therapeutics and new modalities. She sits on the organizing committee for the Chromatographic Society, UK and focuses on opening up opportunities for students and early career scientists in the chromatography network. Her previous research in academia was developing chromatographic methods for the analysis of oligonucleotides—including the implementation of multidimensional LC—sequencing mRNA therapeutics and analyzing alkylating effects of environmental compounds on nucleic acids. Christina is a fellow of the Higher Education Academy and is the industrial supervisor for a Ph.D. project at the university of Sheffield.

Jared Auclair
Vice Provost Research Economic Development, Director of Bioinnovation
Northeastern University

Jared Auclair is currently the Vice Provost Research Economic Development and Director of Bioinnovation in the Office of the Provost at Northeastern University. As Vice Provost Research Economic Development, Dr. Auclair works to strengthen the bonds between education and research missions by strengthening the integration of work-integrated credentialed learning and use-inspired research, co-creating with communities and partners while expanding our global mindset.

As Director of Bioinnovation, Dr. Auclair works to leverage important university activities around biotechnology, bringing together experts from a wide range of disciplines and backgrounds to advance the expansion of Northeastern life sciences programs. In addition to these roles, Dr. Auclair is also the Director of the Biopharmaceutical Analysis Laboratory (BATL), the Asia-Pacific Economic Cooperation Center of Regulatory Excellence in Biotherapeutics and Advanced Therapies and oversees the International Council for Harmonisation training. Lastly, Prof. Auclair serves as the Technical Supervisor for the Life Science Testing Center at Northeastern University, which is a state and CLIA-certified lab. Dr. Auclair collaborates with academic researchers, industry, and government in biopharmaceutical development and analysis. He has expertise in molecular biology, protein biochemistry, analytical chemistry, protein crystallography, and biological mass spectrometry. He is also interested in use-inspired research for the biotechnology industry.

Register Free:
https://www.chromatographyonline.com/ca_w/oligos