EVENTS
UPCOMING EVENT AT THE CAMBRIDGE INNOVATION CENTER, DECEMBER 4TH, 2024!
- The link above will open your default email client. Simply put "IN_PERSON" or "VIRTUAL" in the subject line and hit "Send" to register.
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- TITLE:
- "Accelerating Characterization: Enhanced charge variant characterization of biologics: A comparative analysis of icIEF-MS and traditional workflow for biologics." by Arnik Shah, Ph.D. of Visterra
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- ABSTRACT:
- Accurate characterization of charge variants in biologics is crucial to uphold stringent quality standards ensuring the safety and efficacy of biotherapeutic products and regulatory requirements for biologic licensing application (BLA). These variants, arising from post-translation modifications (PTMs) during bioreactor processing, downstream process or accrue during storage conditions, can significantly impact therapeutic potency, efficacy, and immunogenicity hence characterizing these PTMs are of utmost importance. Conventional methods for characterizing charge variants typically involve labor-intensive and time-consuming fraction enrichment process followed by purity assays. However, recent technological advancements, exemplified by Intabio's/SCIEX innovative platform, enable the seamless integration of capillary isoelectric focusing (cIEF) with mass spectrometry (MS), facilitating rapid and unbiased characterization. In this study, we conduct a comparative assessment of charge variant characterization of investigative mAb-1 using cIEF-MS and traditional methods. Our results obtained from two different workflows were comparable where cIEF-MS based characterization can be achieved in short time and minimized sample processing and analysis-related artifacts, compared to conventional approaches.
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- ABOUT THE SPEAKER:
- Arnik Shah works at Visterra in the Analytical development department, specializing in early and late-stage attribute assessment and method development. With 9 years of experience in biopharmaceutical characterization, he has previously worked at companies such as Baxter, Shire (now Takeda), and Amgen. Throughout his career, Arnik has contributed to the development of various biotherapeutic modalities, including enzyme replacement therapies, monoclonal antibodies (mAbs), T-cell engagers, and mab derived therapetuics. He holds a Ph.D. from Northeastern University.
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- THE VENUE:
- HAVANA ROOM AT THE CAMBRIDGE INNOVATION CENTER (CIC) at One Broadway, Cambridge, MA.
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- AGENDA:
- 3:00 pm - Arrival, appetizers, and networking
- 4:00 pm - Seminar
- 5:00 pm - Additional networking
- 5:45 pm - Adjourn and departure
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