OUTSOURCING ARTICLES
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![path of exponential growth-GettyImages-2229192052]( "Trends In Oligo Scale-Up & Delivery & How They're Impacting Manufacturing")
Trends In Oligo Scale-Up & Delivery & How They're Impacting ManufacturingHere, a panel of experts at the RNA Leaders Conference gives a fantastic overview of where we are today and why, as one expert so nicely put it, “This is one of the most fun times to be an oligo scientist or chemist.”
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![Outsourcing-GettyImages-467648692]( "Contract Manufacturing Outsourcing Trends For Advanced Therapies In 2025 And Beyond")
Contract Manufacturing Outsourcing Trends For Advanced Therapies In 2025 And BeyondContract manufacturing continues to emerge as the widely adopted model for bringing cell therapies, gene therapies, RNA therapeutics, and oligonucleotides to patients worldwide.
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![cars driving on a bridge-GettyImages-1167795076]( "The RNA Synthesis Spectrum: Between Solid-Phase Roots & A Hybrid Enzymatic Future")
The RNA Synthesis Spectrum: Between Solid-Phase Roots & A Hybrid Enzymatic FutureThere were two additional takeaways I had following my conversation with Kuchimanchi, each of which depicts where there still exists quite a bit of dynamism for an industry which can claim an “established” manufacturing paradigm.
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![PCR machine Thermocycler for DNA or RNA quantification-GettyImages-1227432556]( "A Flexible Mindset For Bridging Between Cell-Based Assay Groups")
A Flexible Mindset For Bridging Between Cell-Based Assay GroupsTransferring cell-based assays for biologics starts with defining operator and equipment parameters, positive and negative controls, and a sufficient dynamic range.
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![Tariffs-GettyImages-2203818660]( "The Potential Impact Of U.S. Tariffs On The Biotech Sector: Manufacturing, Funding, And Clinical Trials")
The Potential Impact Of U.S. Tariffs On The Biotech Sector: Manufacturing, Funding, And Clinical TrialsSyner-G Biopharma Group's Raymond Forslund, Ph.D., MBA explores how U.S. tariffs might affect biotech manufacturing, funding, and clinical research.
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![US Tariffs-GettyImages-2197351521]( "Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers")
Navigating Tariffs: Implications And Strategies For Pharmaceuticals ManufacturersThe U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts.
OUTSOURCING VIDEOS
Gain the insight and strategic flexibility needed to confidently navigate the unique scientific, regulatory, and documentation challenges of gene therapy development.
mRNA-based therapeutics require comprehensive analytical testing to meet regulatory requirements. Optimize processes and ensure fast and reliable results as you bring your product to market.
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.
Three Advancing RNA Live panelists share their greatest needs in outsourcing partnerships for mRNA/RNA-LNP products and where sponsors should be the most prescriptive when drafting an MSA with an outsourcing partner.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1387090964 cell and gene therapy]( "Gene And Cell Therapy: Planning For Manufacturing Success Early")
As gene therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations, explore how to optimize plasmid production and reach patients with efficiency.
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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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![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.
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![GettyImages-1354171846-lab-research-development]( "Identifying Sustainable Pathways Toward Oligonucleotide Therapeutics")
What sustainable manufacturing processes best address Oligonucleotide environmental impact while maintaining scalability?
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![GettyImages-462287059-computer-motherboard]( "Built Like A Tech Company: Why CROs Need A New Operating System")
See why building digital, automated infrastructure is essential, and better aligns CROs with today's speed, compliance, and innovation needs.
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![GettyImages-1869998960 patient, doctor, clincial trial]( "Phase IIb Trial: Evaluating A Novel Treatment For Locally Advanced Or Metastatic Breast Cancer")
This case study highlights a successful Phase IIb clinical trial conducted by an Indian biotech company evaluating a novel treatment for Locally Advanced or Metastatic Breast Cancer.
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![GettyImages-1751848523-meeting-evaluation-charts-table]( "What Is The Role Of CROs In Drug Development?")
CROs are not just facilitators but strategic innovators essential for delivering new therapies to patients efficiently and safely.
