| 9:00 - 9:30 a.m. | Continental breakfast and name badge pick-up
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| 9:25 - 9:30 a.m. | Welcome and introductions
Thermo Fisher Scientific
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| 9:30 - 10 a.m. | Plan now or fail later: Why raw materials matter
Darwin Asa, Ph.D, Market Development Manager, Thermo Fisher Scientific- Critical considerations on raw materials including quality, consistency, flexibility, regulatory support, scalability
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| 10:00 - 10:30 a.m. | Purification of mRNA with POROS Oligo (dT)25 Affinity Resin
Jenny England, Ph.D, Manager, Research & Development, Thermo Fisher Scientific - Optimized for your specific molecule to maximize mRNA purification
- Scalable from small (μL or mL) to large (L) scale
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| 10:30 - 11 a.m. | Characterization of mRNA vaccine 5’ and 3’ end products using Thermo Scientific
BioPharma Finder 5.1 software
Robert Ross, Ph.D, Senior Product Applications Specialist, Thermo Fisher Scientific - Accurate and sensitive characterization of capped and uncapped fragments
- Accurate characterization of poly(A) tail distribution with mass error <20 ppm
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| 11:00 - 11:10 a.m. | Coffee break
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| 11:10 - 11:40 a.m. | Direct Mass Technology Mode for the characterization of biopharmaceutical analytes
David Foreman, Ph.D, Sr. Scientist, AR&D Mass Spectrometry, Merck - Direct mass technology mode can be used for the characterization of large heterogeneous analytes which
cannot be easily measure via conventional mass spectrometry technique
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| 11:40 a.m. - 12:10 p.m. | A novel approach for direct characterization of mRNA therapeutics and vaccines using
an LC-MS based workflow
Keeley Murphy, Ph.D, Senior Product Applications Manager, Thermo Fisher Scientific - Direct measurement of mRNA with comprehensive sequence coverage at >85%
- Universal solutions applicable to all types of mRNAs
- Fast analysis and reproducible result
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12:10 - 1:00 p.m.
| Lunch
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| 1:00 - 1:30 p.m. | Comprehensive LC-MS characterization of synthetic single guide RNAs in CRISPR: From
bottom-up to top-down MS analysis
Molly Blevins, Ph.D, Scientist (Technology), Small Molecule Analytical Chemistry, Genentech Research & Development - Higher sequence coverage with improved speed, sensitivity, and digestion efficiency using online, parallel
digestions through immobilized RNase cartridges - Complete (100%) sequence coverage of sgRNA using primer protection.
- Strategies to achieve high sequence coverage of large oligonucleotides (~100 nt) via a direct sequencing
approach
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| 1:30 - 2 p.m. | Characterization of CQAs in antisense oligonucleotides using LC-UV-MS
William Zhang, Ph.D, Scientist II, Analytical Development, Biogen - Liquid chromatography-mass spectrometry (LC-MS) workflow has been widely used for analytical control of
quality attributes in antisense oligonucleotide, such as identity, purity, and impurities. This talk will discuss
some advancements and challenges in the characterizations of CQAs using LC-UV-MS, including sequence
identity confirmation and semi-quantitative analysis of site-specific n-1 impurities.
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| 2:00 - 2:30 p.m. | Streamlining workflow from characterization to monitoring of therapeutic oligonucleotides
impurities using Orbitrap based LC-HRAM-MS platforms
Hao Yang, Ph.D, Senior Product Applications Specialist, Thermo Fisher Scientific - Complete characterization and identification of oligonucleotide impurities through the combination of low
mass deviation of the measured monoisotopic mass and good correlation of the experimental MS/MS
fragmentation against the predicted spectra - Seamless method migration from research and development to quality control using Thermo Scientific
Chromeleon CDS eWorkflow procedure for direct method transfer and execution of the workflow
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| 2:30 - 3:00 p.m. | Bioanalysis to support oligonucleotide PK/PD assessment
John Chen, Ph.D, Sr. VP, Bioanalytical Services, NovaBioAssays - Various bioanalysis tools to support oligonucleotide PK assessment including LC-MS, hELISA, RT-qPCR
- Various techniques on sample processing, LC separation and mass spec detection for oligonucleotide
LC-MS analysis - Oligonucleotide PD assessment including small molecules biomarkers, protein or enzyme, and gene expression
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| 3:00 - 3:10 p.m. | Coffee Break
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| 3:10 - 3:40 p.m. | Profiling and controlling impurities of N1-methylpseudo UTP for mRNA vaccines and therapeutics
Syed Raza, M.S., Senior Manager Manufacturing and Process Development, Thermo Fisher Scientific - Comprehensive examination of impurity profile and its implications in full process of m1ΨTP synthesis
- Analytical solutions to detect and identify nucleoside and nucleotide impurities
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| 3:40 - 4:10 p.m. | Characterization of lipid nanoparticle (LNP) composition using UHPLC-MS
Reiko Kiyonami, Ph.D, Senior Product Applications Specialist, Thermo Fisher Scientific - Confident confirmation of lipid components by LC-HRAM MS
- Sensitive detection and identification of impurities at 0.001%
- Simultaneous lipid component quantification and metabolites characterization
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| 4:10 p.m. | Wrap up and adjourn
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