MANUFACTURING ARTICLES
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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.
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![Global health safety regulation-GettyImages-2245658628]( "How Informal FDA Feedback Is Quietly Driving RNA Capital Allocation")
How Informal FDA Feedback Is Quietly Driving RNA Capital AllocationSubtle FDA signals — especially in pre-IND talks — are quietly shaping RNA investment. Early regulatory feedback on CMC and comparability now drives how investors assess risk and allocate capital.
MANUFACTURING VIDEOS
High Throughput Screening (HTS) chromatography tools can accelerate process development and reduce material usage. Learn about a solution that addresses challenges with their use in new modalities.
Examine why template sequence characteristics are relevant for cGMP manufacturing of high-quality mRNA and consider insights on how to develop a scalable, robust, and economically viable process.
Cytiva is just about that initial oligo synthesis right? Wrong! Find out all about the synthesis systems friends and family across the full oligo workflow.
Meet our OligoProcess™ oligonucleotide synthesizer – exceptional scale ranges in 3 different scale designs to fit your needs up to 1800 mmol and beyond.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Exploring the use of automation in cell therapy and advanced therapeutic medicinal product manufacturing to improve safety, quality, and compliance is a key factor in advancing patient care.
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![GettyImages-1418152314]( "Unpacking The Importance Of Lipid Nanoparticle Production Platforms")
Batch processing platforms for LNPs lack efficiency, appropriate controls, and yield optimization. Continuous manufacturing platforms may address some of those issues.
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![Outsourcing RNA Feature Image]( "Outsourcing RNA-LNP Production: A Key To Competitive Success")
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.
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Meeting the goals of today’s industry requires a deeper look at how to continuously achieve maximum utilization and reduce waste without sacrificing quality in the race to be first to market.
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![iStock-1087219198-lab-computer-cleanroom-research-development-production]( "GMP-Source® And Phase-Appropriate Use For Early-Stage Clinical Trials")
GMP-Source is a more robust, less rigid alternative to full cGMP production that mirrors nearly all of the oversight and quality standards of full cGMP production while relaxing certain commercial standards, helping companies overcome the hurdles that can stall early development.
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![GettyImages-1194781834-cell]( "mRNA-Lipid Nanoparticles Circumvent Viral Vector Limitations")
Both physical and chemical nonviral gene delivery systems for ex vivo genetic modification offer advantages over viral vectors, including smaller scale production and the low risk of immunogenicity.
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![GettyImages-1285212896 lab]( "Large Scale Purification Of Oligonucleotides With IEX")
As oligonucleotide-based drugs gain momentum in therapeutic development, refining their manufacturing processes through solutions like ion exchange chromatography (IEX) becomes crucial.
