MANUFACTURING ARTICLES
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![DNA target nanodrugs-GettyImages-1405926704]( "RNA Therapeutics: Why CMC Strategy Will Define The Next Decade")
RNA Therapeutics: Why CMC Strategy Will Define The Next DecadeAs RNA matures into an industrial platform, long-term success will depend less on discovery and more on scalable CMC systems, integration, and execution.
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![AI Medical Technology-GettyImages-2242544252]( "Rethinking The Oligonucleotide Backbone: Why RNA Therapeutics May Need A New Molecular Design Framework")
Rethinking The Oligonucleotide Backbone: Why RNA Therapeutics May Need A New Molecular Design FrameworkNew backbone chemistries could unlock greater control over delivery, specificity, and safety, expanding the molecular design space for RNA medicines.
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![Virology, infectious diseases, virus diagnostics, virus research, biotechnology-GettyImages-2219621039]( "RNA Platforms: What Transfers And What Breaks")
RNA Platforms: What Transfers And What BreaksA practical framework for distinguishing reusable RNA platform knowledge from biology-specific unknowns as therapeutics expand into new tissues and indications.
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![Burrowing owl-GettyImages-964611070]( "Stay \"Stereocurious\": What The Future Holds For Oligo Quality")
Stay "Stereocurious": What The Future Holds For Oligo QualityOverall, there were two areas of discussion at TIDES that demonstrate the amount of growth we have yet to do as a space — particularly in the realms of regulatory development and quality. As I intend to showcase here in part 1 of this muti-part article, this year’s TIDES was a great reflection of the tension(s) that can arise as we realize how much space exists between where we are and where we’re going next.
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![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.
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![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.
MANUFACTURING VIDEOS
Experts in the pharmaceutical industry share insights on how to effectively implement a strong, integrated CPV and APQR framework. Watch now and learn how automation enhances efficiency.
Dr. Jason Coleman, Clinical Application Scientist Lead with Precision NanoSystems, presents on an overview of the development and scale-up activities needed to progress this saRNA vaccine to the clinic.
Learn how flexible facility design and process innovation are accelerating pDNA manufacturing, as well as key strategies to avoid scale-up pitfalls and meet growing therapeutic demand.
We share our experience working with organizations as they adopt solutions for automated data acquisition, aggregation, visualizations, and statistical analysis.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-597935610 cell and gene]( "The Sponsor's Clinical Development Handbook For Gene Therapy Trials")
Gene therapy has existed for decades, but the field is not as mature as it may seem. Here, the author provides essential insights and strategies for overcoming gene therapy development challenges.
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![GettyImages-1295693748-mRNA]( "Addressing Challenges In mRNA Drug Development And Manufacturing")
mRNA-based drug products serve as an ideal platform for use in infectious disease, protein replacement, and immuno-oncology applications due to the simplicity of manufacturing and robust immune response.
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![Scientists working in lab-GettyImages-542935478]( "Effective Environmental Monitoring And Control In Pharma Operations")
A structured contamination control strategy uses the Plan, Do, Study, Act model, focusing on EMPQ, meticulous planning, trend analysis, and continuous improvement with CAPA and change control.
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![GettyImages-1090255620-lab-research-microscope-computer]( "When Is A New Biologic Ready For GMP Production?")
While there are differences by modality in DNA, RNA, and protein, find general recommendations on questions to prepare for and steps to consider when preparing to move to clinic.
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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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![Guidance-Puzzle-Regulatory-iStock-489087670]( "CMC And Regulatory Considerations For CRISPR Therapies")
This article explores the details of Chemistry, Manufacturing, and Controls and Critical Quality Attributes, which play an important role in gene editing.
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![Gene Therapy GettyImages-1164556175]( "Advancing Cell And Gene Therapy Clinical Development In 2023")
Examine considerations on bringing together the CMC and clinical teams early in the development process, promoting transparency and communication with regulators, and increasing patient access and diversity in clinical trials.
