![Country [Change]](http://images.sciex.com/shared/icons/globe-white.png){kind=icon}
Country [Change]
Shop
Partners
AB Sciex is doing business as SCIEX. © 2010-2018 AB Sciex. The trademarks mentioned herein are the property of the AB Sciex Pte. Ltd. or their respective owners. AB SCIEX™ is being used under license. Beckman Coulter® is being used under license. Product(s) may not be available in all countries. For information on availability, please contact your local representative. For research use only. Not for use in diagnostic procedures.
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.
In drug discovery laboratories, there is often a need to generate trusted analytical data on hundreds of thousands of drug candidates to allow confident decisions to be made. Sample prep, instrument run time, and data processing are all challenges that must be overcome.
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.
If we lived in an ideal world, it would be possible to unambiguously identify metabolites using a single analytical experiment. This analytical technique would need to be efficient and easily generate the information needed from a routine assay that is also robust, enabling confident decision-making during drug discovery.
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.
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.
Contact Support