SCIEX

Articles by SCIEX

Charge heterogeneity is present in most biopharmaceutical protein products. During the manufacturing process, charge heterogeneity of the protein therapeutics can occur due to enzymatic cleavage and chemical post-translational modifications (PTM). For therapeutics like ADCs, not only the antibody contributes to the heterogeneity but also the linker and payload, which add even more complexity to the charge variant profiles. Characterizing the charge heterogeneity of ADCs is essential for critical quality attribute (CQA) assessment to ensure drug safety, efficacy, and potency.

Earlier 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.

Lipid 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).

Lipid-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.

Wednesday, 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.

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.

Quantitative LC–MS Workflow for Cell Culture Media Monitoring

***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***