June 20
11:00 am - 12:00 pm EDT

LOCAL TIME

Utilizing novel icIEF fractionation and mass spec for the charge characterization of biotherapeutics

Imaged capillary isoelectric focusing (icIEF) has emerged as the preferred method for protein charge profiling. Lan Li, Senior Principal Scientist at Amgen, provides insights into the need for charge variant analysis, sharing her evaluation of the MauriceFlex technology for fractionations in the context of charge variant analysis of monoclonal antibodies. She discusses her initial analytical method assessment to determine if it is fit for purpose, fractionation evaluation and outcome, general feedback on the technology, and recommendations based on her overall experience. Amreen Jonas, Principal Associate Scientist at Mersana Therapeutics, demonstrates the use of the MauriceFlex™ instrument to fractionate a monoclonal antibody (mAb) using icIEF followed by intact mass spec analysis, enabling the accurate identification of distinct isoforms, and providing insights into the mAb’s charge heterogeneity. The MauriceFlex instrument is a novel platform that integrates icIEF, CE-SDS analysis, and protein charge isoform fractionation into one unit, enabling users to go beyond routine charge and size and perform charge variant analysis of their molecule at any point without requiring the use of separate techniques like IEX and HPLC.

  1. How to characterize protein charge heterogenity
  2. How to gain novel insights in protein characterization by combining icIEF with mass spec analysis
  3. How to develop a simplified and flexible workflow to improve protein characterization

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Lan Li

Lan Li

Process Development Sr Principal Scientist, Amgen Inc

Lan is a Process Development Sr Principal Scientist at Amgen Inc with an impressive background in analytical science technologies and experience in method development/validation and GLP/GMP processes within laboratory and manufacturing environments. Lan specializes in chromatography, capillary electrophoresis, mass spectrometry, and solid-state characterization technologies for biologics and synthetic pharmaceuticals. Lan’s interests in evaluating innovative technologies led to their implementations in both biologics and synthetic laboratories. Lan has a BSc Majors in Physical Chemistry from Lanzhou University (China) and Applied Chemistry & Biology from Ryerson University (Canada), and a MSc in Health Care Administrations from CSULB

Amreen Jonas

Amreen Jonas

Principal Associate Scientist, Mersana Therapeutics

Amreen is a Principal Associate Scientist in the Analytical Chemistry, CMC department of Mersana Therapeutics where she supports method development and extended characterization of a broad range of proteins, including ADCs, antibodies, antibody fragments and free drug. She received her MS in pharmaceutical sciences from Campbell University and prior to joining Mersana worked at Eurofins PSS in their process analytics department. She has a Bachelor of Pharmacy from Mumbai University, India.

Kefei Wang

Kefei Wang

Sr. Product Manager, Bio-Techne

Kefei Wang has been a Senior Product Manager at ProteinSimple of Bio-Techne since May 2022. Prior to joining Bio-techne, Kefei spent more than 20 years in the field of chromatography and mass spectrometry working mostly in analytical instrument companies on new product introduction, application development, marketing and commercial management. Kefei studied Chemistry at Nanjing University with BS and MS degrees, and received a PhD in Chemistry from University of Alberta.

Surani Fernando
moderator

Surani Fernando

Healthcare journalist, writer & podcaster

Surani Fernando is a seasoned healthcare journalist and editor with over 13 years experience covering the biopharma industry. A Sydney native, she started her investigative journalism career in London covering clinical trials, M&A and financing deals for BioPharm Insight, later moving to New York to continue her work as an enterprise journalist and editorial leader for GlobalData and Reorg. She is now based in Madrid working as a freelance journalist, consultant writer and podcast producer. In November 2023, she launched the Raising Biotech podcast.