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.
Introduction Customer Experience Day (CX Day) is a special occasion for SCIEX, celebrated every first Tuesday in October. It’s a day dedicated to recognizing the incredible value of our customers and the relentless dedication of our associates who strive to make...
At the heart of everything we do is ensuring that your workflows and team are empowered to achieve optimal results with your SCIEX instruments, software, consumables, and services. Every interaction with SCIEX is designed to support your success through the dedication...
A few years ago, it was discovered that messenger RNA (mRNA) encapsulated in lipid nanoparticles (LNPs) could result in mRNA adducts due to the breakdown products of N-oxide impurities. The ionizable lipids used in LNPs are especially susceptible to forming N-oxide impurities.
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.
In 1998, the US Food and Drug Administration (FDA) approved fomivirsen as the first therapeutic oligonucleotide therapeutic. This approval marked a revolution of mechanism of action discovered decades before finally coming to fruition. Since then, the landscape of chemical modifications of oligonucleotides, conjugations and formulations has evolved tremendously, contributing to improvements in stability, efficacy and safety. Today, more than a dozen antisense oligonucleotides (ASOs) and small interfering RNA (siRNA) drugs are on the market, most of which are designated as orphan drugs for treating rare genetic diseases.
Prime editing (PE) is a next-generation gene editing technology that utilizes a Cas9 protein fused to a prime editing guide ribonucleic acid (pegRNA) to achieve high CRISPR/Cas9 editing efficiency and precision. However, the length requirement of pegRNAs at 120–250 nucleotides (nt) and their high level of secondary structure formation present analytical challenges for the purity analysis of chemically synthesized pegRNAs during development and quality control (QC).
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.
Monitoring product quality attributes (PQAs) throughout monoclonal antibody (mAb) development is vital to ensuring drug safety and efficacy. By adopting orthogonal analytical techniques and integrating new technologies that have the potential to provide more information, it is possible to improve product quality and manufacturing efficiency and make more informed decisions.