CE‑SDS remains a cornerstone assay for characterizing fragmentation, aggregation, and product‑related impurities in therapeutic proteins. UV detection has been the long‑standing standard. However, it frequently struggles with baseline noise, limited sensitivity for minor fragments, and subjective integration.
In monoclonal antibody (mAb) development, assessment of purity and integrity of the protein in question is critical. CE‑SDS is the gold standard assay and is routinely run from analytical development through QC and lot release. It’s trusted because it consistently delivers quantitative, size‑based insight into purity and fragmentation, and it fits naturally into regulated environments.
In a recent webinar, available on demand, scientists Luiza Chrojan and Ryan Hylands from Pharmaron, provided insights into the deployment of capillary gel electrophoresis (CGE) within cell and gene therapy. Luiza and Ryan shared purity data on plasmids used for adeno-associated virus (AAV) manufacturing and data on AAV genome integrity, viral protein (VP) purity and VP ratios using the BioPhase 8800 system.
Peter Holper, Staff Applications Scientist at SCIEX, US, shares his tips and tricks on AAV analysis using CE with the BioPhase 8800 system and the PA 800 Plus system.
Plasmid DNA serves a variety of purposes, from critical starting material for proteins, mRNA, viral vectors, and drug substances. Below, Dr. Emma Bjorgum, the Vice President of Client Services of the DNA Business Unit at Aldevron and an expert in plasmid manufacturing, provided insights into the process and an outlook on the future.
Lipid-based nanoparticles (LNPs) are effective non-viral vectors for delivering messenger RNA (mRNA) products, most notably used for production of vaccines against the recent SARS-CoV-2 pandemic.
In a recent webinar, available on demand, Jingtao Zhang (PhD), Scientific Director, and Daniel Turner, Scientist at Catalent® Pharma Solutions, presented their approaches to addressing stability challenges of mRNA-based products.
Certain next-gen vaccines and gene therapy applications rely on the usage of adeno-associated viruses (AAV) as a delivery vehicle. To ensure the safety and efficacy of viral vector drugs, multiple critical quality attributes (CQAs) need to be well characterized.
Lipid nanoparticles (LNPs) are widely used vehicles for mRNA-based therapeutics and vaccines. However, ionizable lipids used in LNPs can be susceptible to N-oxide impurities that can cause functional loss of the mRNA cargo.