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 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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![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
Delve into the significance of adept interpersonal leadership within your drug safety program, shedding light on the operational and financial benefits that stem from fostering a collaborative environment.
Learn how predictive models can monitor key CQAs, such as RNA concentration and nucleoside triphosphate consumption, and explore RBP and MIT’s vision for revolutionizing biomanufacturing.
Stay ahead in mRNA therapeutic development by mastering the essential quality systems, process controls, and analytical methods required for robust GMP production and efficient manufacturing.
In part two of this webinar series, presenters focus on avoiding potential risks, such as unexpected budget changes and unplanned change orders, that could jeopardize the success of a clinical trial.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![jhs_encourages_current_and_potential_customers_to_visit_our_facilities]( "Step-By-Step Guide To Tech Transfer Preparation And Execution")
How does a sponsor accurately transfer detailed knowledge about its product composition, development, and current manufacturing processes to its CDMO?
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![GettyImages-1054148730-clinical-outsourcing-partner-FSP]( "The Shift Toward Flexible FSP Models")
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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![GettyImages-1284529278-syringe-pre-filled-PFS]( "New Perspectives On Accelerating Genetic Nanomedicines Through The Regulatory Pathway")
Discover how regulatory bodies are adopting a risk-based approach to address the unique challenges of genetic nanomedicines, and stakeholder engagement is essential.
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![cooperation-iStock-1226854109]( "The M.O. Behind Choosing A CDMO: Three Considerations For New Drug Developers")
The greatest challenge in drug development can be finding a team capable of carrying a molecule through the complexities that lie between the research lab and the patient’s bedside. Discover three considerations that build a foundation for partnership.
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![iStock-879831370-plasmid-lab-cell]( "Pre-Banking And Avoiding Manufacturing Challenges For GMP Plasmids Containing Unstable Sequence Regions")
Ensuring consistent replication and proper retention of plasmid DNA sequence is vital to the economics and efficiency in generating starting materials used for production of AAV delivered gene therapy and mRNA vaccines and therapeutics.
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![Manufacturing]( "Bridging The Skills Gap In Biopharma")
Employees must have the skills to effectively execute on process development and manufacturing operations. How do you ensure they are updated on complex bioprocessing techniques and technologies?
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![Scientist, laboratory, microscope analysis-GettyImages-1530246394]( "Expression Analysis Of CTLA-4, PD-1, And PD-L1")
Advance personalized immunotherapy in NSCLC by leveraging qPCR-based analysis of CTLA-4, PD-1, and PD-L1 expression to identify predictive biomarkers and guide more effective treatment strategies.
