MANUFACTURING ARTICLES
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![Drone Point View of Overpass and City Traffic at Night-GettyImages-1279832748]( "A New Approach To RNA Synthesis And Purification: Rethinking A Persistent Bottleneck")
A New Approach To RNA Synthesis And Purification: Rethinking A Persistent BottleneckPhotocleavable supports enable light-triggered RNA release, reducing reliance on chromatography and streamlining synthesis, scalability, and purity for complex RNA therapeutics.
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![Genetic Engineering, biotechnology gene analysis-GettyImages-1485674887]( "Oligos, mRNA, Or Gene Editing: Where Should You Bet?")
Oligos, mRNA, Or Gene Editing: Where Should You Bet?Investing in RNA and gene editing requires balancing risk, timing, and scale — understanding how oligos, mRNA, and CRISPR each drive value across a converging biotech landscape.
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![Success Transformation, improvement, leadership-GettyImages-1417761158]( "Beyond The Gold Standard(s): Modernizing Oligonucleotide Synthesis")
Beyond The Gold Standard(s): Modernizing Oligonucleotide SynthesisA few weeks ago, I had the chance to sit down with OPT Congress speaker Phil Baran, Richard Lerner Chair Professor, Department of Chemistry, Scripps Research. Baran was slated to (and did) present a keynote on the innovations shaping the next generation of oligo synthesis. Here, I share the biggest takeaways I had from our conversation, touching on how he sees the science of oligo chemistry and manufacturing advancing in the near and far future.
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![Business support, teamwork-GettyImages-2267605245]( "The RNA Ties That Bind: 3 Takeaways From The OPT Congress")
The RNA Ties That Bind: 3 Takeaways From The OPT CongressHere, I unpack three takeaways I had from the OPT Congress, each of which I’d argue are indicative of the interconnectedness across the genetic medicines field.
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![Test Tubes-GettyImages-139700261]( "Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign")
Rethinking ATMP Assurance When Sterility Timelines, Reality MisalignThe compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.
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![cell biology, biochemistry, cellular signaling, cell integrity-GettyImages-2196575143]( "The Potency Chains Of Events For mRNA/LNP Therapeutics")
The Potency Chains Of Events For mRNA/LNP TherapeuticsPotency in mRNA/LNP therapies depends on two chains: manufacturing/cold chain integrity and complex in vivo delivery. Breakdowns at any step — from stability to translation — can limit efficacy and safety.
MANUFACTURING VIDEOS
In this segment of the BioProcess Online Live event CMC, SCALE UP, & THE ROAD TO mRNA REGULATORY APPROVAL, panelists Akhilesh Bhambhani, Sr. Director, Biologics Drug Product Development at Ultragenyx Pharmaceuticals and Roberta Duncan, VP and mRNA Program Lead at Seqirus share early learnings on the regulatory path.
Learn about a small oligonucleotide synthesizer with big impact that features a user-friendly interface, compact footprint, and more. This small scale system is user friendly and supports scale up.
The rapidly expanding oligo market demands optimized RNA synthesis. Examine key innovations and workflow insights to maximize resources and control long-term manufacturing costs.
Chief Scientific Officer and Founder Christian Cobaugh, Ph.D., examines the critical quality attributes of mRNA and LNPs that are pivotal to enhancing drug efficacy and safety.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1076055404 chromatography, purification]( "Efficiently Select Your Antibody Or Antibody Variant Purification Strategy")
Explore the evolution of antibody therapeutics from monoclonal antibodies to next-gen formats and discover innovative strategies for purifying these complex molecules in today’s landscape.
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![GettyImages-648181930-viral-development-vaccine-lab]( "mRNA/saRNA Manufacturing - RNA Therapeutic Delivery And Applications")
Venkata Indurthi, Ph.D., shares his knowledge and experience with manufacturing RNA, including insight into RNA delivery and the applications–present and future–that innovations in the field are enabling.
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![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.
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![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.
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![GettyImages-1097343012 lab, production, manufacturing, bioprocessing]( "Production And Clarification Of Lentiviral Vectors")
Explore scalable processes for lentiviral vector production and clarification at the 50 L scale, utilizing the CTS LV-MAX system and single-use bioreactors for robust gene therapy manufacturing.
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![GettyImages-1387090964 cell and gene therapy]( "Moving CGTx Clinical Development Forward In 2023")
Gain insights on cell and gene therapy (CGTx) clinical trial design and commercialization strategies as a panel of industry experts share their considerations.
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Using its Supplier Relationship Excellence program, Amgen opened the lines of communication with suppliers and created a feedback loop where data can be shared to optimize operational performance.
