Nucleic Acid Insights

Quality by design in #mRNAmanufacturing: at-line monitoring coupled with DOE for higher #IVTyield and efficiency of purification Due to the catalytic, multicomponent nature of the #IVTreaction, optimization is a multi-factorial problem, ideally suited to a design of experiments (DoE) approach. Sartorius BIA Separations’ Rok Sekirnik (Head of Process Development for mRNA and pDNA) introduces a DoE approach to coupling #affinitychromatography with reverse-phase chromatography to enhance #downstreammRNAprocessing Watch at your convenience below:

#Webinar now available on demand! mRNA Characterization - from 5’ cap to poly (A): what IPRP-LC–MS can tell you #mRNA is a biotherapeutic modality primarily used in #vaccines and undergoes a complex manufacturing process involving #invitrotranscription. In order to ensure the desired product quality of mRNA therapeutics, critical quality attributes must be maintained within appropriate limits. Therefore, the implementation of robust analytical methods is crucial for making quality decisions. Phenomenex’s Roxana Eggleston-Rangel (Advanced Workflows Applications Manager, Pharma & Biopharma) introduces a novel #mRNAcharacterization workflow that yields mRNA molecules exceeding 1,000 nucleotides in length, with a 5' cap and a poly (A) tail Watch at your convenience below:

#Article now available! Bridging the translational gap: humanized liver models as predictive tools for #RNA therapeutic success Small interfering RNA (#siRNA) therapeutics are being applied in a growing range of disease areas, but traditional animal models often fail to predict human responses, leading to clinical trial failures. In order to reduce late-stage failures and accelerate #RNAtherapeuticdevelopment, it is essential to adopt models that offer a more human-relevant platform. In this article, humanized liver chimeric mouse models as a strategy to improve preclinical predictions of siRNA efficacy and safety is explored Access below:

Faster, smaller, smarter: intelligent manufacturing of #mRNA through the power of process analytical technologies The #RNAtherapeutics field is rapidly expanding, with applications from #cancervaccines to gene editing. To avoid manufacturing bottlenecks that slow innovation, it is crucial to adopt technologies that allow developers to measure and control production processes in real time, ensuring final product quality and accelerated timelines. This month, ReciBioPharm’s Aaron Cowley (CSO) and Edita Botonjic-Sehic (Senior Director, Process Sciences) will discuss the benefits of integrating #processanalyticaltechnologies (PAT) within #mRNAmanufacture and explore the platform’s ability to predict and monitor #CQAs, including #RNA concentration and #nucleosidetriphosphate consumption. Register for this upcoming #webinar below:

#Article now available! Precision in production: optimizing monitoring and quality control for high-value #plasmids Variable pathlength technology, also known as slope spectroscopy, addresses issues of around ensuring regulatory compliance, and lack of industry standardization by adjusting pathlengths to maintain a constant concentration and eliminate the need for dilutions. In this article, the SoloVPE® system used to determine plasmid #DNApurity ratios will be explored, along with other #variablepathlengthtechnology applications across various stages of #genetherapy, including fermentation, downstream processing, chromatography, #mRNApurity measurements, and AAV titer analysis. Read at your convenience below:

Quality by design in #mRNAmanufacturing: at-line monitoring coupled with DOE for higher #IVTyield and efficiency of purification Due to the catalytic, multicomponent nature of the #IVTreaction, optimization is a multi-factorial problem, ideally suited to a design of experiments (DoE) approach. Next month, Sartorius BIA Separations’ Rok Sekirnik (Head of Process Development for mRNA and pDNA) will introduce a novel DoE approach to maximize IVT yield in the upstream processing of #mRNA. He will also describe a DoE approach to coupling #affinitychromatography with reverse-phase chromatography to enhance #downstreammRNAprocessing Register for this upcoming #webinar below:

#Webinar now available on demand! Accelerating #LNPoptimization and development Optimizing #lipidnanoparticle (#LNP) manufacturing processes manually is challenging, and switching equipment for clinical production requires re-optimization, which takes a lot of time and resources. Here, Unchained Labs’ Kevin Lance (Director of Marketing) introduces a combination of novel #LNPproduction and analysis tools, offering continuous production and #rapidparticleanalysis, significantly reducing the workload for encapsulation efficiency #assays Watch at your convenience below:

Faster, smaller, smarter: intelligent manufacturing of #mRNA through the power of process analytical technologies The #RNAtherapeutics field is rapidly expanding, with applications from #cancervaccines to gene editing. To avoid manufacturing bottlenecks that slow innovation, it is crucial to adopt technologies that allow developers to measure and control production processes in real time, ensuring final product quality and accelerated timelines. Next month, ReciBioPharm’s Aaron Cowley (CSO) and Edita Botonjic-Sehic (Senior Director, Process Sciences) will discuss the benefits of integrating #processanalyticaltechnologies (PAT) within #mRNAmanufacture and explore the platform’s ability to predict and monitor #CQAs, including #RNA concentration and #nucleosidetriphosphate consumption. Register for this upcoming #webinar below:

#Webinar now available on demand! Implementation of an improved platform for downstream processing of #plasmidDNA #pDNA represents the backbone of most cell and #genetherapy production workflows. As a key raw material, it can have an important effect on subsequent downstream processes, therefore it is crucial to implement strategies that maximize its purity and yield. AstraZeneca’s Justina Martinkiene (Associate Scientist, Purification Sciences) and Sartorius BIA Separations’ Klemen Božič (Process Development Scientist) provide insights on how to optimize the #pDNA capture process, and showcase data on a novel approach for removing undesired #pDNAisoforms. Watch at your convenience below:

Biopharmaceutical analytics unveiled: expert insights and customer success stories Manufacturing #pDNA and #RNA for #genetherapies and vaccines requires sophisticated and easy-to-use analytical methods. Similarly, the characterization of delivery systems such as #LNPs and #AAVvectors for these nucleic acids requires comprehensive analytical insights to ensure their safety. However, traditional analytical assays are often time-consuming and require multiple steps. Access the on demand recording for the 4 sessions below to learn about innovative analytical solutions for streamlining the production and characterization of pDNA, #mRNA, and LNPs: Session 1: Enhancing pDNA production for gene therapy https://buff.ly/3ACXknk Session 2: Enhancing mRNA production with advanced analytics https://buff.ly/3AscuvP Session 3: Advancing LNP characterization for drug delivery https://buff.ly/3YCOU7u Session 4: Accelerating AAV process development https://buff.ly/492Gn2F