Overview:

Liquid chromatography-mass spectrometry (LC-MS) is a vital tool for analytical characterization and bioprocess development support. However there are two critical bottlenecks to its implementation into the respective workflows: the complexity of the crude bioprocess samples and the perceived difficulty in mastering the LC-MS analysis. We address these two questions in this two-part seminar. In the first part, we present a streamlined LC-MS platform that serves two critical purposes for bioprocesses: biosimilar comparative assessment and bioprocess analytical development. In the second part, we pivot the very same LC-MS platform to monitoring critical quality attributes (CQA) of sgRNA and mRNA for product quality and process consistency, and how these MS-based RNA analysis is made accessible to biologics experts. 

Learning Objectives

·        Simplified LC-MS acquisition using BioAccord™ LC-MS System, a benchtop TOF MS designed for ease of operation for analysts of all levels of expertise

·        Utilization of the waters_connect™ Intact Mass App for streamlined automated data acquisition and analysis with compliance-ready features to ensure data integrity

·        Automated ProA purification for biosimilar subunit analysis

·        Biosimilar CQAs analysis (Fab vs Fc modifications, orthogonality between mab subunit workflow and released N-glycan assays)

·        RNA CQAs analysis (sgRNA, mRNA and RNA digest fragment mapping)

Agenda:

§  09.00 – 09.30: Registration

§  09.30– 10.15: Streamlined LC-MS Platform for Biosimilar Comparative Assessment and Bioprocess Analytical Development  (Speaker: Terence)

§  10.15 – 10.25: Waters Commercial Video Break

§  10.25 - 11.20: LC-MS for RNA Therapeutics to Ensure Product Quality and Process Consistency (Speaker: YanTing)

§  11.20 – 11.30: Q&A

Who is for It?

ü  Scientists, Technicians and Managers, who are charged with bioprocess analytics and analyzing therapeutic RNA samples.

ü  Others from pharmaceutical and contract organizations looking towards developing and commercializing these molecules, who want to better understand the analytical challenges of producing high quality products and processes.

       เภสัชกรที่เข้าฟังสัมมนาและผ่านการทดสอบ จะได้รับ 2.0 หน่วยกิตการศึกษาต่อเนื่อง

รหัสกิจกรรม

2004-2-000-013-07-2567

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