MANUFACTURING ARTICLES
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![MacKay suspension bridge-GettyImages-2281791194]( "Bridging The Atlantic: A European Executive's Guide To Building A Successful U.S. RNA Business (Pt. 2)")
Bridging The Atlantic: A European Executive's Guide To Building A Successful U.S. RNA Business (Pt. 2)European RNA biotech leaders can accelerate U.S. success by aligning fundraising, partnerships, manufacturing, hiring, and regulatory strategy from day one.
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![GettyImages-1494348289_lab microscope]( "The Delivery Challenge For In Vivo Cell Engineering")
The Delivery Challenge For In Vivo Cell EngineeringAs RNA therapies expand beyond the liver, delivery—not payload design—has become the defining challenge for precise, scalable in vivo cell engineering.
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![GettyImages-480155972_Leukodystrophy]( "Building An ASO For TUBB4A-Related Leukodystrophy (Pt. 1)")
Building An ASO For TUBB4A-Related Leukodystrophy (Pt. 1)SynaptixBio CEO Dan Williams explains how the company selected an ASO for TUBB4A leukodystrophy by balancing potency, safety, and translational rigor to advance a rare disease therapy.
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![Antibody-oligonucleotide conjugates or AOC-GettyImages-1826415365]( "Nucleic Acid Ligases: Connecting The Pieces For Sustainable And Scalable Production Of Oligonucleotide Therapeutics")
Nucleic Acid Ligases: Connecting The Pieces For Sustainable And Scalable Production Of Oligonucleotide TherapeuticsChemoenzymatic ligation could overcome the scalability and sustainability limits of traditional oligonucleotide manufacturing, enabling more efficient RNA drug production.
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![Pen being used to write a check-GettyImages-173602091]( "Soliman Says… 5 Questions Every RNA Platform Must Answer Before Investors Write The Check")
Soliman Says… 5 Questions Every RNA Platform Must Answer Before Investors Write The CheckA practical framework for evaluating whether an RNA company has the science, strategy, scalability, and discipline to become a lasting platform.
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![Small interfering RNA, sirna, mrna, crispr-GettyImages-1409578453]( "Building A Self-Driving Lab For LNP Development")
Building A Self-Driving Lab For LNP DevelopmentWith commercially available components, MIT researchers built a platform that accelerates LNP process development, optimization, and autonomous manufacturing research.
MANUFACTURING VIDEOS
In this Advancing RNA Live clip, Sanofi’s Sumit Luthra highlights the learnings we’ve made to-date about how our processes — both in terms of unit operations and process conditions — inform our LNP composition/heterogeneity.
In this Advancing RNA Live clip, panelists Venkat Krishnamurthy and April Sena home in on the economic, molecular, and biological challenges complicating the transition to enzymatic ligation today.
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.
TFF Pharmaceuticals’ Kayla Hannon and University of Sheffield’s Dr. Zoltán Kis discuss the cost and capacity implications of therapeutic demand surges in this Surge Manufacturing for Biopharma Resilience segment.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Sustainable green building-GettyImages-1468396766]( "How Is Additive Manufacturing Delivering On Sustainability Goals?")
One of the key concerns for many biopharmaceutical companies is minimizing environmental impact. Learn about additive manufacturing and the significant advantages it offers to biomanufacturers.
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![scientist laboratory research iStock-942266140]( "How Data Analytics Accelerates Transition To Bioprocessing 4.0")
Following successful Industry 4.0 implementation in the automotive, communications, aerospace, and other industries, the biopharma industry is now joining the digital revolution.
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![iStock-1125935859-logistics-supply chain-shipping-transportation]( "2022 Updates To The Harmonized System (HS) And Harmonized Tariff Schedule (HTS)")
HS 2022 has 351 sets of modifications covering a wide range of products, introducing significant improvements to the Harmonized System, which will be used to update tariff systems with participating countries.
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![GettyImages-2183428964 lab]( "Analytical Method Release And Stability Platform For RNA Drug Substance")
We offer comprehensive analytical support across the R&D space, including method development, validation, process characterization, in-process testing, process validation, and GMP release testing.
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![GettyImages-1334686671-cold-chain-cryopreservation-logistics]( "Validate Cryopreservation As A Defined Input, Not A Variable")
Treating cryopreservation as a validated, controlled input improves consistency, quality, and patient outcomes by reducing variability across cell therapy manufacturing, storage, and distribution.
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![Implementing Continued Process Verification Feature]( "How To Automate Continued Process Verification")
This eBook describes automation of continued process verification and offers a one-click solution for statistical trending of data, campaign reports, and annual product quality review.
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The biopharmaceutical industry is in the midst of a period of rapid growth. It is also experiencing increasing uncertainty, diversification of modalities, and cost pressure. To address these challenges, the industry will need to embrace the facility of the future – a new biomanufacturing paradigm. This infographic identifies market trends challenging biopharmaceutical companies, business drivers to meet market needs, as well as requirements and aspirations for the factory of the future.
