We’re Attending WCBP Symposium
The WCBP Symposium is known as the most esteemed yearly conference. The symposium focuses on the role of current and emerging CMC analytical technology in relation to evolving US and international regulatory perspectives. Their established reputation is highly regarded.
This year, WCBP will be co-sponsored by the US FDA. The FDA’s specialized regulatory expertise is crucial for effectively communicating this technology and its applications. Attendees will have the opportunity to listen to and interact with influential figures in various fields. This covers a wide range of topics, such as CMC development strategies, innovative analytical characterization, global submission strategies, next-generation therapeutics & vaccines, and the challenges and potential of CRISPR-based therapeutics, which have the potential to revolutionize the future of medicine. We are excited to attend an enlightening symposium and look forward to meeting you there.
Visit Us at Table 3
We’d love to meet with you and discuss how we could help improve your operations.
Interested in our Technical Sessions?
Join our Technical Sessions on Wednesday, January 24 in the Palm Court Ballroom. Registration for these sessions is not required, but seating is limited.
Learn more about these informative technical sessions that discuss microchip CE-MS for rapid, deep and sensitive analysis of biopharmaceuticals, and characterization of therapeutic antibody charge variants in drug development by microfluidic native capillary electrophoresis-mass spectrometry.
Dr. Sara Carillo
NIBRT
Technical Session 1
Microchip CE-MS for rapid, deep and sensitive analysis of biopharmaceuticals
Wednesday, January 24
12:30 – 1:00 PM EST
As the challenges posed by increased complexity and new modalities in the biopharmaceutical industry, the availability of analytical tools to simplify protein characterization is crucial.
Capillary zone electrophoresis allows efficient separation based on charge state of analytes, with the microfluidic device developed by 908 Devices, facilitating method development and hyphenation with powerful detection techniques such as high-resolution accurate mass (HRAM) mass spectrometry (MS). At NIBRT we have worked to include ZipChip in many routine and non-routine workflows, ranging from mAb-based therapeutics characterization, to released glycan analysis and cell culture media analysis to assist upstream manufacturing operations. With new and complex modalities entering the biopharma market, we moved our attention on gene therapies product, in particular adeno-associated virus (AAV) characterization and use CZE-MS for multi-level characterization of viral proteins. All the workflows developed highlighted the versatility of the ZipChip device and its unique features in terms of short analysis times, easy method development and boosted sensitivity for samples with limited availability.
Dr. Zhijie Wu
Regeneron
Technical Session 2
Characterization of therapeutic antibody charge variants in drug development by microfluidic native capillary electrophoresis-mass spectrometry
Wednesday, January 24
1:00 – 1:30 PM EST
Therapeutic antibodies are a major class of biopharmaceuticals that can treat a variety of diseases. As an important type of product-related impurities, charge variants and their related heterogeneity arising from post-translational modifications (PTMs) and truncations can affect the stability, efficacy, and safety of the drug product. In this study, we present the development and application of native microfluidic capillary electrophoresis (CE)-mass spectrometry (MS) to monitor the charge variants in therapeutic antibody drug candidates.
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