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Date & Time:
June 13th, 2024
9:00 AM – 12:05 PM CST (China Standard Time)
Speakers:
Addressing the Challenges in Developing a Control Strategy for Therapeutic Oligonucleotides
9:00-9:30 am, with Mike Webb
Oligonucleotides require a control strategy which presents significant analytical challenges. We will discuss how to address accurate and reproducible impurity control and the best approaches for reproducible impurity separation and quantitation, as well as product purity. We will also cover the determination of the consistency of the diastereomeric ratio of phosphorothioated oligonucleotides.
Take the Wheel and Drive Your Oligo Synthesis Where You Want
9:30-10:15 am, with Carina Strand
In this presentation you will:
- Learn about the oligonucleotide therapeutic market & oligo therapeutics in development
- Gain insight on challenges you may face when bringing your process in-house and key considerations to address those challenges
- Think of the future first with scale-up manufacturing at the top of your mind.
Your ÄKTA Oligosynt™ System: It’s More Than a Machine
11:00-11:35 am, with Peter Guterstam
In this presentation you will:
- Learn about the complete oligo workflow from Cytiva
- Find out what reagents (particularly oligo workflow reagents) are available and how these are optimized for use on Cytiva synthesis systems
- Understand how early workflow considerations can impact future manufacturing
Quality Control/Process Development/Manufacturing of Oligonucleotide API(DS)
11:35-12:05 pm, with Alex Xu
Reviewing of oligonucleotide drugs (ASO, siRNA, Aptamer, miRNA, sgRNA, etc.) including catalog, drugable advantage and current market reality, this presentation will focus on the challenge of oligo production in the terms of analytical development and qualification/validation, impurities analysis and control, and quality control of long oligonucleotide production, and introduction of Veliter with one-stop oligo CDMO solutions from preclinical to commercial.
Bio: Carina joined Cytiva in 2010 as a product manager responsible for oligonucleotide synthesizers. She was recruited from AstraZeneca where she had spent her time as a formulation scientist, managing different projects as well as being quality assurance officer in a multipurpose facility. She holds a MSc degree in analytical chemistry.
Carina Strandh, Senior Global Product Manager, Cytiva
Mike Webb, Ph.D., Founder and CEO, Mike Webb Pharma
Bio: Mike Webb PhD was the VP of Development Chemistry and Analysis for GSK in the UK and was heavily involved in developing GSK’s oligonucleotide pipeline. Since leaving GSK in 2016 he has been consulting with Big Pharma and Biotechnology companies in the development, analysis and manufacture of therapeutic oligonucleotides from pre-clinical to marketing submission
Peter Guterstam, Senior Global Product Manager, Cytiva
Bio: Peter Guterstam is Product Manager at Cytiva with responsibility for products tailored for downstream processing of Advanced Therapy Medicinal Products, primarily nucleic acids. Peter earned his PhD in Neurochemistry from Stockholm University in 2009. It was a project regrading cellular delivery of oligo-therapeutics by conjugation and particle formation with cell-penetrating peptides. He has been with Cytiva since 2003 and he is based in Uppsala, Sweden. Peter has led development of high flow adsorber products, he has extensive experience from product management ranging from chromatography products to solid supports for synthesis, and he has experience from oligo synthesis and purification internally and at customer sites.
Alex Xu, Founder and CEO, Veliter
Bio: Alex Xu, with his extensive background in small molecule drugs and oligonucleotides, has significantly contributed to the field since 2007. His roles have included Senior Scientist and Project Leader at Ariad Pharm. Inc., Qiagen, and Nitto Avecia Inc.
Since July 2019, Alex returned to China from Boston to establish Shenzhen Veliter Biotechnology Co., Ltd, Guangdong Veliter Biomedical Technology Co., Ltd, and Hunan Veliter Biomedical Technology Co., Ltd respectively.
Alex and his leadership aim to foster game changing nucleic acid drug therapies through strategic partnerships with global gene therapy innovators.
Kathryn L. Ackley, Ph.D., CMC Consultant Specializing in Oligonucleotides
Bio: Dr. Ackley earned her doctorate in analytical chemistry from the University of Cincinnati. She spent 16 years working in CDMOs serving the pharmaceutical industry. She has held positions in QC, production management, project management, and business development. Dr. Ackley was the Vice President of Development for Nitto Denko Avecia, one of the leading oligonucleotide CDMOs. Since 2018, Dr. Ackley has served as an independent CMC consultant. She is a member of the scientific advisory boards of the US TIDES conference and Chimica Oggi- Chemistry Today.
Agenda:
Complimentary Webcasts will be made available in English with Chinese Translation
此次线上直播将同步提供中英版本
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Short Break
10:15-10:30 am
Manufacturing Aspects of a Phase 1 Oligonucleotide IND
10:30-11:00 am, with Kathryn L. Ackley, Ph.D
This presentation will cover:
- How to start planning
- Assessing the molecule and the drug product
- Selecting CMOs
- Helpful suggestions
- Preparing the IND