New Strategies for a Better Glycosylation Profile
November 4th 2024Glycan analysis provides key information on critical quality attributes that could affect stability, safety and efficacy of a protein therapeutic. Specific needs for understanding the glycosylation profiles change throughout the drug development process, but the requirement for high-resolution glycan information remains the same and is essential to help ensure product quality.
mAb Characterization Process Innovations
February 8th 2024Earlier assessment of molecules provides valuable insights into the manufacturing developability of molecules, reducing the need for unnecessary experimentation. The Intabio ZT system has the potential to make in-depth characterization of biopharmaceutical product charge variants quicker and more efficient to meet demanding timelines during early-phase clinical development.
Comprehensive Analysis of Novel mRNA-LNP Constructs with Innovative Analytical Methods
May 10th 2023Lipid nanoparticles (LNPs) are effective non-viral carriers, which are widely used as delivery vehicles for gene-based drugs such as messenger RNA (mRNA). To mitigate safety risks and ensure product efficacy, it is important to comprehensively characterize the lipids used for LNPs and their related impurities, as well as the mRNA integrity, purity and its critical quality attributes (CQAs).
CGE-LIF: A Robust and Sensitive Approach for Characterizing mRNAs LNPs
January 24th 2023Lipid-based nanoparticles (LNPs) are effective non-viral vectors for delivering messenger RNA products (mRNA), most notably used for vaccine production against the recent SARS-CoV-2 pandemic. In this executive summary, you will discover a robust and high-throughput kit-based analysis of nucleic acids extracted from different mRNA-LNP samples.
On the way towards personalized medicine: Gene therapy AAV characterization by CE and LC-MS
October 19th 2022As more gene therapy applications make inroads into research and clinical practice, the development and safe manufacturing of the therapeutic products involved have demanded more from associated analytical technologies. One of the most widely used gene-therapy vectors is AAV, and key technologies for the characterization of AAVs include CE and LC-MS.
Moving SWATH LC–MS Host Cell Protein Analysis into a GMP Environment?
October 6th 2021Wednesday, October 6, 2021 at 12pm EDT | 9am PDT | 5pm BST | 6pm CEST In this webinar, you will learn about the possibility of GMP method transfer for HCP assays leveraging a robust and automated workflow based on combining data-dependent and data-independent mass spectrometry. A study of data from multiple projects over three years demonstrated the robustness and reproducibility of the method.
Exposing Contamination—Advances in Food and Environmental Analysis A Virtual Symposium
Monday, July 19, 2021, 02:00 PM EDT Tuesday, July 20, 2021, 02:00 PM EDT Join us for this free online event to learn about important developments in the analysis of contaminants in a wide range of food and environmental matrices using a range of chromatographic, detection, and sample preparation techniques. A few hours of your time will deliver enormous benefits for your work.
Characterization of Next Generation Antibody-Drug Conjugates (ADCs) by Mass Spectrometry
March 2nd 2021*Live Date: Tuesday, March 2, 2021 at 11am EST | 8am PST | 4pm GMT | 5pm CET* In this webinar, you will learn how LC-MS has been broadly leveraged to accelerate the development of antibody-drug conjugates (ADCs). *Available On Demand Until March 2, 2022*
Quantitative LC–MS Workflow for Cell Culture Media Monitoring
January 20th 2021***Live: Wednesday, January 20, 2021 at 11am EST | 8am PST | 4 pm GMT | 5pm CET *** Cell culture media (CCM) optimization is a critical step during the development and scale up of biotherapeutic manufacturing process. In particular, the emphasis on quality by design has made it necessary to understand how the components of CCM change during production and how these changes relate to product quality. In this webcast, learn how targeted cell-culture media workflow can help scientists understand growth media for biotherapeutics and improve their manufacturing process. ***On demand available after final airing until Jan. 20, 2022***