OUTSOURCING ARTICLES
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![Potter at work-GettyImages-1142834523]( "Beyond The Hype: How 2025's Successes & Realities Will Shape mRNA In 2026")
Beyond The Hype: How 2025's Successes & Realities Will Shape mRNA In 2026Here, in part two of this multi-part series, we hear from Melissa Bonner, CSO of nChroma Bio and Andy Geall, CDO of Replicate Biosciences, who call attention to several developments of the past year they’ve been watching and how they see these developments informing our conversations about and work with mRNA in 2026 and beyond.
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![GettyImages-1128195910-vial-white-powder-lyophilization]( "Four Reasons You Should Choose Lyophilization for Your Next Project")
Four Reasons You Should Choose Lyophilization for Your Next ProjectLyophilization ensures product stability, extends shelf life, supports sensitive formulations, and simplifies storage and transport, making it a critical choice for modern drug development projects.
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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.
OUTSOURCING VIDEOS
While the speed of production and flexibility of mRNA are appealing, several industry challenges must still be addressed to realize the full potential and further expand its use.
With decades of experience, we offer a flexible and collaborative partnership model for manufacturing excellence that enables our clients to increase speed to market with full regulatory confidence.
Speaking of outsourcing, Akhilesh Bhambhani, Sr. Director, Biologics Drug Product Development at Ultragenyx Pharmaceuticals and Roberta Duncan, VP and mRNA Program Lead at Seqirus share what they’re manufacturing in house, what they’re outsourcing, and why in this segment from our recent CMC, Scale Up, & The Road To mRNA Regulatory Approval event.
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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1313742092 tech partner]( "The Execution Stage Of Technology Transfer")
What are the key elements in the readiness stage of a technology transfer that are critical to your success? Explore Process Performance Qualification (PPQ) and the execution stage of PDA TR-65.
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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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![mRNA GettyImages-1356994684]( "mRNA Manufacturing And Formulation")
From fermentation to formulation, mRNA manufacturing requires a toolbox of technologies, services, and expertise. Explore our portfolio of solutions for making, purifying, and formulating mRNA.
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![GettyImages-1437855768-lipid-nanoparticle-lnp-mrna vaccine]( "The Current And Future Value Of mRNA Vaccines And Therapeutics")
Discover how decades of research have propelled mRNA technology to the forefront of therapeutic development and learn how our expertise is advancing mRNA drug development.
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![GettyImages-1087219366-filling-vials-mechanical]( "Solving Aseptic Filling Challenges For Your Advanced Therapeutics")
Explore aseptic filling workcells, modalities, agency approvals, and insights from six expert users that offer a peer-driven look at industry innovation and benchmarks.
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![Warehouse]( "Reducing Costs & Risks: A Pharma Guide To FTZ Subzones For U.S. Drug Manufacturing")
Utilized wisely, FTZs and subzones can be tools for cost savings and can enable pharma companies to leverage the benefits of American manufacturing.
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![Decision Timeline: Considerations In Selecting An Outsourced Solution]( "Is Not Using A CDMO Slowing Down Your Process Development?")
Consider what process development capabilities you have versus what you could possibly gain from working with a CDMO to not only be successful but also improve your chances of getting to market sooner.
