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BioNet and Sartorius' company BIA Separations collaborate on production process development of mRNA vaccines
On November 2nd,  BioNet, a leading biotech company manufacturing genetically engineered vaccines, and BIA Separations, now part of Sartorius, a leading biochromatography development and manufacturing company, announced the successful development of an optimized mRNA manufacturing process.
We are proud to announce that the new process has been successfully applied to the production of mRNA in the fight against COVID-19.
 
We are very pleased to be collaborating with BIA Separations / Sartorius in developing and tech-transferring optimized mRNA vaccine manufacturing processes. When time is of the essence, it is crucial to be able to rely on key partners whilst maintaining the highest level of quality in every aspect of our work. We are also very proud that our team was able to produce two kinds of genetic vaccines (DNA and mRNA) and we look forward to expanding our partnership with the BIA Separations’ team on future projects.
Hong Thai Pham, CEO, BioNet
New discovery - Chromatographic purification with CIMmultus™ Oligo dT increases mRNA stability
One of the major challenges of mRNA-based vaccines has been their requirement for distribution and storage at extremely low temperatures, indicating that exposure of mRNA to suboptimal physico-chemical conditions can result in degradation and loss of potency. In this study, we compare the stability of model mRNA drug substance prepared by affinity chromatography with the stability of mRNA purified by precipitation. We show that both purification methods lead to highly pure mRNA drug substance, however, mRNA purified by chromatography remains stable for 28 days at 37°C, whereas mRNA purified by precipitation is subject to significant degradation under the same storage conditions.
New poster - High Yield mRNA Production Process from E. Coli to Highly Pure mRNA
Different mRNA production protocols can employ multiple steps to produce mature mRNA with all its structural components. The 5’ cap and the polyadenylated tail, for example, can be added co-transcriptionally during the IVT reaction, or as secondary enzymatic steps.
Purification protocols may need to be adapted to provide intermediate purification. Here we present fast capture of polyadenylated mRNA from IVT mixture with CIMmultus Oligo dT18 column and CIMac PrimaS, our rapid HPLC assay for quantification of individual IVT reaction components.
The 2021 BPI Readers’ Choice Awards – Viral Clearance in the AAV purification process - winning article in the downstream categhory
We are happy to announce winning BPI’s 2021 Readers’ Choice Awards program in the downstream category.  The article entitled Viral Clearance was written in collaboration with REGENXBIO, and originally published in the April 2021 issue of BPI. Viral Clearance received the highest number of votes from their readers, who ranked the nominees in terms of their innovativeness, presentability, and applicability.
You can find the eBook (and the other Readers’ Choice Award eBooks) online at http://bpi.bioprocessintl.com/2021-readers-choice-awards.
New eBook - PATfix™ pDNA analytical platform for rapid monitoring and optimization of pDNA production process
Plasmid DNA (pDNA) has become a crucial component in the production of next generation therapeutics such as messenger RNA (mRNA) and viral vectors. As companies ramp up their production capabilities and move towards clinical applications, obtaining cGMP grade pDNA has become a production bottleneck, leading to lengthy production delays. There is a growing market demand for solutions that can streamline the production of cGMP pDNA and help optimize downstream processes (DSP) for better yields & purity. The key step in this process is having quantifiably reliable analytics that give rapid results for process optimization and scale-up, as well as production runs.
Herein, we present lysis optimization of pFix5 plasmid obtained from raw E. coli paste, and subsequently its linearization suitable for IVT reaction template. Specifically, we show the advantages to be gained during process development and production by using the PATfix pDNA platform to rapidly separate and quantify all key components, thus optimizing the plasmid processing workflow.
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