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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![Maximize efficiency-GettyImages-1289739851]( "How To Minimize The Impact Of Stability Testing On Gene Therapy Batch Yield")
How To Minimize The Impact Of Stability Testing On Gene Therapy Batch Yield8/27/2024This article outlines strategies for reducing the volumes required for gene therapy stability studies, with the goal of conserving product for patients, while remaining compliant and delivering data on CQAs.
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![GettyImages-184295057]( "The Process Map To Ensure Biopharma Raw Materials Supply")
The Process Map To Ensure Biopharma Raw Materials Supply8/16/2022In new product introduction, there is often a lack of a basic data package for a product being scaled up for clinical or launch supplies. This can lead to several issues, e.g., capacity and lead time restrictions, oversupply, and more. A stepwise process can be used as a guideline for introducing a material to support new drug substance manufacture.
