MANUFACTURING ARTICLES
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![FDA headquarters, white oak campus-GettyImages-1413289936]( "First AMT Program OK'd Under New FDA Designation — Here's What To Know")
First AMT Program OK'd Under New FDA Designation — Here's What To KnowThe FDA's new Advanced Manufacturing Technology program has its first recipient, a development expected to reveal the specific ways the program benefits drug innovators.
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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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![business analytics, data management, strategy-GettyImages-1408832606]( "A Road Map For PAT Monitoring And Control")
A Road Map For PAT Monitoring And ControlProcess analytic technology monitoring and control is rapidly progressing. BioPhorum shares new best practices on how to move from concept through life cycle management and/or regulatory approval of the PAT application.
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![syringe, vaccine, europe flag-GettyImages-1285131583]( "EMA Issues Draft Guideline On Quality Aspects Of mRNA Vaccines")
EMA Issues Draft Guideline On Quality Aspects Of mRNA VaccinesThe EMA's new draft guideline applies to mRNA vaccines for infectious diseases, providing guidance on manufacturing, characterization, specifications, and more. The deadline for public comments is Sept. 30, 2025.
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![Genetic Research-GettyImages-477335408]( "Do We Really Understand Plasmid Quality's Effects On mRNA Production?")
Do We Really Understand Plasmid Quality's Effects On mRNA Production?Two experts examine the current guidelines and specs for plasmid DNA and question whether our understanding is sufficient.
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![quality control, approval-GettyImages-2170531311]( "ICH Revises Q1 Guideline, Advancing Stability Testing Standards")
ICH Revises Q1 Guideline, Advancing Stability Testing StandardsIn April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.
MANUFACTURING VIDEOS
Innovation and invention are often limited by challenges in deployment. Here, Cell & Gene Live’s panelists, Nathaniel Wang, CEO and Co-Founder, Replicate Bioscience and Sam Deutch, EVP of Research and Early Development at Nutcracker Therapeutics detail how is the field solving these issues. They cover how evolution in the scale up production of novel engineering technologies impacts their near term and long-term deployment.
Dr. John Lewis, Founder and CEO, Entos Pharmaceuticals, presents RNA Vaccine Development to Phase I.
In this video, Russell Johnson, VP Formulation Research for RVAC Medicines, and Aalok Shah, Director of Formulation & Drug Delivery for Strand Therapeutics, outline several examples of foundational research that could provide insights into how we attain more specific cellular uptake of LNPs.
With benefits across applications, nanoplasmids are designed to replace antiquated bacterial backbones, while eliminating antibiotic markers that can cause regulatory concerns.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Lipid nanoparticle mRNA vaccine-GettyImages-1418152448]( "Advancing A LNP Formulation To Clinical And Commercial Manufacturing")
Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.
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![Pall feature image]( "How High-Performance Syringe Filters Extend The Life Of Analytic Instruments And Columns")
This scientific brief reviews how high-performance syringe filters protect and extend the life of analytical HPLC and UHPLC instruments and columns.
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![Handshaking-GettyImages-537252274]( "Communication And Transparency In Secondary Supply Qualification")
What should you look for when searching for the right vendor to help you maintain security of raw materials and how can you establish communication that builds confidence?
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![Integrating Genetic Medicine Into Clinical Care]( "Optimization Of Transient Transfection Of MSCs With Plasmid DNA Or mRNA")
Read through the results of our efforts to produce an optimal protocol for the transient transfection of hMSCs with pDNA or mRNA using non-viral means.
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![GettyImages-1310857892-dna-genetic-gene]( "Unlocking The Full Potential Of Genomic Medicine")
There are two key challenges to realizing the potential of genomic medicines, but potential technological solutions are on the horizon, and we examine each.
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![GettyImages-1356993441 mRNA]( "mRNA Purification Using Anion Exchange Chromatography At Ambient Temperature")
Explore how anion exchange chromatography with dual gradient elution enables efficient mRNA purification at ambient temperature.
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![GettyImages-1387090964 cell and gene therapy]( "Moving CGTx Clinical Development Forward In 2023")
Gain insights on cell and gene therapy (CGTx) clinical trial design and commercialization strategies as a panel of industry experts share their considerations.
