OUTSOURCING ARTICLES
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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.
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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.
OUTSOURCING VIDEOS
Watch this presentation to equip stakeholders with actionable strategies and a comprehensive understanding of the evolving clinical trial management landscape in the context of ICH guidelines.
Developing a client-sponsored Target Product Profile (TPP) and Analytical Target Profile (ATP) is critical to move your drug product to clinic efficiently and meet acceptance criteria.
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.
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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![Regulatory network digital EHR EMR patient data GettyImages-1298626492]( "Getting CMC Right For Emerging Technologies")
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.
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![GettyImages-1183908006 bioanalysis]( "5 Outdated Practices Holding Back Modern Bioanalysis")
Bioanalysis must replace outdated paper, manual processes, and disjointed systems with integrated, automated platforms for continuous validation, efficiency, compliance, and to support complex modern therapies.
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![GettyImages-1459917555-lab-research-development-gene-genetic]( "Mastering mRNA Manufacturing: A Focus on Raw Materials & Supply Assurance")
Rapid advancements in mRNA-based therapeutic development have underscored the role of raw material quality and supply chain management in ensuring their successful production.
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![mRNA GettyImages-1428646288]( "Advanced Therapies Going Mainstream: Are We There Yet?")
Advanced therapies are nearing mainstream adoption, with cell, mRNA, and oligonucleotide treatments expanding into broader indications. Learn what’s driving this shift and what manufacturers must do.
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![GettyImages-1145414430_Oligonucleotides]( "Selection And Evaluation Of Hybridization Capture Probes For LC/MS Analysis Of Oligonucleotides")
To overcome challenges in oligonucleotide LC/MS bioanalysis, consider optimizing probe design by evaluating alternative chemistries like PNA for improved recovery and chromatographic performance.
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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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![GettyImages-1354171846-lab-research-development]( "Identifying Sustainable Pathways Toward Oligonucleotide Therapeutics")
What sustainable manufacturing processes best address Oligonucleotide environmental impact while maintaining scalability?
