OUTSOURCING ARTICLES
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Trends In Oligo Scale-Up & Delivery & How They're Impacting Manufacturing
Here, a panel of experts at the RNA Leaders Conference give 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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Contract Manufacturing Outsourcing Trends For Advanced Therapies In 2025 And Beyond
Contract 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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The RNA Synthesis Spectrum: Between Solid-Phase Roots & A Hybrid Enzymatic Future
There 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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A Flexible Mindset For Bridging Between Cell-Based Assay Groups
Transferring 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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The Potential Impact Of U.S. Tariffs On The Biotech Sector: Manufacturing, Funding, And Clinical Trials
Syner-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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Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers
The 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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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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Explore the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.
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In addition to codifying some best practices, R3 recommends that sponsors adopt an approach to identifying and managing areas of risk to mitigate potential issues and enhance overall success.
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Flexible FSP models are reshaping clinical outsourcing by offering sponsors scalable, cost-predictable partnerships that preserve control, enhance quality, and support long-term strategic goals.
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Delve into the exciting potential of OVs, including the critical role of cell and virus seed banks, and discover key considerations for establishing cell and virus banks for OV production.
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Contract research organizations can be invaluable partners in clinical trials. Dive into the full spectrum of benefits you'll experience by partnering with a globally established and well-resourced CRO.
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Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.