ARTICLES BY BIOPHORUM
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![image001-(5)]( "A Phase-Appropriate Approach For Assay Validation In Cell & Gene Therapies")
A Phase-Appropriate Approach For Assay Validation In Cell & Gene Therapies10/2/2024This article promotes alignment on a common phase-appropriate approach to analytical assay validation with respect to the critical quality attributes of the most common cell/gene therapy modalities.
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![Getty Image-1134867308 edited]( "How To Leverage Platform And Process Characterization Data To Accelerate Cell & Gene Therapies")
How To Leverage Platform And Process Characterization Data To Accelerate Cell & Gene Therapies9/10/2024This article discusses how cell and gene therapy companies can use prior knowledge and platforms to leverage process characterization to reduce the testing and/or studies required during process validation for drug substance and drug product manufacturing processes.
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![Taking a shortcut-GettyImages-2101007925]( "End-To-End mRNA DS And DP Manufacturing Processes")
End-To-End mRNA DS And DP Manufacturing Processes7/10/2024This article demystifies the manufacture of mRNA encapsulated in lipid nanoparticles across unit operations for plasmid linearization, drug substance (DS) manufacture, and drug product (DP) manufacture.
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![RNA-GettyImages-1411871727]( "Understanding CQAs For mRNA/Lipid Nanoparticle Product Development And Manufacture")
Understanding CQAs For mRNA/Lipid Nanoparticle Product Development And Manufacture12/13/2023BioPhorum recently created a resource of potential critical quality attributes (CQAs) for mRNA products from the early stages of drug development to commercial manufacturing. We asked two of the paper’s authors some questions to explore the key areas in more detail.
