MANUFACTURING ARTICLES
-
![RNA, siRNA, mRNA, CRISPR-GettyImages-1409578455]( "Scaling RNA Therapeutics: Purification, LNP Formulation, And GMP Manufacturing (Pt. 2)")
Scaling RNA Therapeutics: Purification, LNP Formulation, And GMP Manufacturing (Pt. 2)Part 2 explores the downstream technologies that turn RNA into a therapeutic product, from impurity removal and LNP formulation to GMP infrastructure and scalable manufacturing.
-
![Green Business-GettyImages-2179499504]( "What Makes An RNA Platform Investable? Lessons From The Last Wave Of Biotech Financing")
What Makes An RNA Platform Investable? Lessons From The Last Wave Of Biotech FinancingRNA investing has shifted from hype to scalability, forcing companies to prove manufacturability, delivery strength, and platform-wide value.
-
![new drugs by genome editing-GettyImages-1407089196]( "RNA Manufacturing Foundations: From DNA Templates To In Vitro Transcription (Pt. 1)")
RNA Manufacturing Foundations: From DNA Templates To In Vitro Transcription (Pt. 1)Cell-free RNA production is reshaping biomanufacturing through modular IVT workflows, advanced capping strategies, and scalable DNA template design.
-
![Molecular biology, mRNA strands, genetics-GettyImages-2198118160]( "Engineering RNA Payload Distribution In LNPs To Unlock Higher In Vivo Gene Editing Efficiency")
Engineering RNA Payload Distribution In LNPs To Unlock Higher In Vivo Gene Editing EfficiencyNew research shows RNA payload distribution inside LNPs — not just encapsulation efficiency — may be key to unlocking stronger in vivo gene editing performance.
-
![Virus, pathogen, bacteria, biotechnology, bacterium, biolaboratory, new X disease, brain illness-GettyImages-1955429813]( "RNA Modification-Mediated Translational Control In Immune Cells")
RNA Modification-Mediated Translational Control In Immune CellsExploring how m6A RNA modifications control immune cell translation, influencing inflammation, tumor immunity, T cell activation, and future immunotherapies.
-
![BPO-Modulus-IMG_1]( "Repeating Sanofi's Ballroom Design On Two Continents")
Repeating Sanofi's Ballroom Design On Two ContinentsMoveable walls and a stunning number of robotics at its sites in France and Singapore, among other features, has earned Sanofi international recognition for innovation.
MANUFACTURING VIDEOS
Tune in as Roberta Duncan, VP of the mRNA program at Seqirus; Duke Human Vaccine Institute Associate Director of Upstream and Downstream Process Development Jason Dickens, Ph.D.; and Jin Zhou, Executive Director of Process Development for mRNA and Protein Biologics at Ultragenyx share supply chain and manufacturing capacity constraints in the face of the urgency to address COVID-19. This is an excerpt from the Bioprocess Online Live event - mRNA Manufacturing: Bright Future, Big Challenges.
In this snippet, panelist Alex Aust (with the help of several live attendee commenters) tackles a particularly tricky question: Are our outsourcing partnerships producing high quality products today, and what are the most common root causes of batch failures?
Achieving cost-effective manufacturing while maintaining high quality standards today is one of the biggest challenges facing companies outsourcing mRNA/RNA development. In turn, panelists Qian Ruan, Andy Geall, and Alex Aust reflect on how and where they’ve seen the costs of mRNA-LNP manufacturing evolving/fluctuating in recent years.
Here, Ethris’ Christan Dohmen and Tune Therapeutics’ Stu Sundseth share their take on the most meaningful strategies for reducing dsRNA production. But this discussion also probes a deeper question: Is dsRNA still the most relevant impurity the industry should be chasing, or should focus shift to other contaminants?
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![GettyImages-1218518899-test-tube-research-lab-scientist-discovery]( "mRNA/saRNA Manufacturing RNA Analytics And Testing")
Venkata Indurthi, Ph.D., shares his knowledge and experience with manufacturing RNA, including key downstream considerations for RNA characterization and purity and how optimization can result in more efficient dosing.
-
![GettyImages-1368058797 vial, fill finish]( "Key Topics And Trends In Aseptic Filling")
Aseptic filling is vital yet often guided by outdated practices. Discover expert insights on modern technologies, evolving regulations, and data-driven strategies to improve compliance and reduce risk in this critical manufacturing step.
-
![GettyImages-1183908006 bioanalysis]( "5 Outdated Practices Holding Back Modern Bioanalysis")
Bioanalysis must replace outdated paper, manual processes, and disjointed systems with integrated, automated platforms for continuous validation, efficiency, compliance, and to support complex modern therapies.
-
Manufacturing RNA-containing LNPs demands specialized expertise. Explore some of the challenges of RNA-LNP drug manufacturing and the advantages of outsourcing RNA-LNP formulations.
-
![GettyImages-1300035668-nanoparticle-particle]( "Lipid Nanoparticle Development, Manufacturing Advance Novel Therapeutics")
An effective partner must possess the necessary unique analytical capabilities for LNP characterization and the ability to support clients from concept to commercialization.
-
![iStock-1295693740-covid-coronavirus-vaccine-mrna]( "Developing A Scalable RNA-LNP Drug Product For Clinical Translation")
Accelerate essential process development activities with instrumentation solution allowing for highly reproducible and scalable production of RNA-LNPs.
-
![171026-101024_MDA_F61_12673_FINAL]( "Integrated Approach In Managing CPV And APQR")
Many companies continue to manually collect data. Utilizing digital technologies can greatly improve productivity and efficiency by enabling real-time monitoring and streamlining regulatory reporting.
