ARTICLES BY BIOPHORUM
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![Planning productivity-GettyImages-1489661764]( "A Justification For Using In-Process Controls In Place Of Cleaning Validation")
A Justification For Using In-Process Controls In Place Of Cleaning Validation1/9/2025This article provides a procedure for using and cleaning shared columns and column packing equipment and using in-process controls that eliminate the need for cleaning validation.
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![iStock-649107516]( "A Risk-Based Approach To Filter Integrity Testing Annex 1 Requirements For Biologics DS")
A Risk-Based Approach To Filter Integrity Testing Annex 1 Requirements For Biologics DS11/8/2024How do the principles of filter integrity testing described in EudraLex Annex 1 apply to low bioburden drug substance manufacturing? And how can using a risk-based approach help?
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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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![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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![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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![covid vaccine coronavirus-GettyImages-1263021678]( "A Holistic Approach To Container Closure Integrity")
A Holistic Approach To Container Closure Integrity5/20/2024Regulations are pushing for an approach to container closure integrity that builds quality into the design and processes rather than testing/inspecting the manufactured item.
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![industry 4 technology-GettyImages-1296634922]( "How To Unlock Efficiency In MES Integrations")
How To Unlock Efficiency In MES Integrations5/16/2024This article outlines the significant benefits and framework for manufacturing execution system (MES) integration with systems such as enterprise resource planning.
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![Mycoplasma iStock-680220480]( "Evaluating, Validating, And Implementing NAT-Based Mycoplasma Detection Methods")
Evaluating, Validating, And Implementing NAT-Based Mycoplasma Detection Methods5/3/2024Regulatory authorities advocate using alternative adventitious agent tests, but adoption has been slow. Here’s how to validate an alternative mycoplasma detection assay.
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![Cell and Gene genetic lab Getty Images-1209892070]( "Developing A Process Performance Qualification Master Plan For Gene Therapies")
Developing A Process Performance Qualification Master Plan For Gene Therapies4/19/2024This article provides considerations and a framework for a Process Performance Qualification Master Plan in the gene therapy industry. It is useful for sponsors with any level of experience.
