Guest Columns & From The Editor
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Gene Editing Versus Gene Therapy: Is There A Difference?
1/31/2024
This article navigates the nomenclature that underlies gene therapy and gene editing technologies and explores the latest advancements in genome medicine.
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Inside Cell & Gene Live “2024 Regulatory Outlook With FDA’s Dr. Peter Marks And Dr. Nicole Verdun”
1/30/2024
In case you missed it, our recent Cell & Gene Live, 2024 Regulatory Outlook with FDA’s Dr. Peter Marks and Dr. Nicole Verdun, is available on demand. Here's a summary of the event.
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Relational Risk Analysis For The Bio/Pharma Industry
1/29/2024
Successfully developing and manufacturing biopharmaceuticals depends on identifying, analyzing, and managing a wide variety of risks. This article presents a novel alternative risk analysis approach that provides a simple, easy, and effective method for quickly and efficiently modeling and analyzing any risk.
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Picking The Best Virus Sample Prep Method In Process Development
1/26/2024
Optimizing downstream operations in viral vaccine development starts with characterization. Learn strategies for picking the best sample prep method.
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FDA Draft Guidance On “Rare Diseases: Considerations For The Development Of Drugs And Biological Products”
1/26/2024
Accenture Applied Life Science Solutions' Raj Bandaru, Ph.D. breaks down, summarizes, and shares detailed insight on the recent FDA Draft Guidance that addresses “Rare Diseases: Considerations for the Development of Drugs and Biological Products.”
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21 New Downstream Technologies Being Considered To Fix Capacity Problems
1/25/2024
Downstream bottlenecks are a growing problem for legacy chromatography processes that can't keep pace with more robust upstream output. BioPlan has been tracking alternatives and discusses them here.
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FDA Issues Draft Guidance For Cell & Gene Therapy Potency Assurance
1/25/2024
The FDA recently released a draft guidance, Potency Assurance for Cellular and Gene Therapy Products. This article summarizes the draft guidance. The public comment period ends March 27, 2024.
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Shaping A Digitally Enabled Commercialization Road Map For Your Cell/Gene Therapy Company
1/25/2024
For cell and gene therapy companies, it is critical for commercial, marketing, and digital leaders to understand key business decisions that shape the digital backbone of your commercialization road map.
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Driving Pharma/Biotech Capacity With Smart Manufacturing
1/24/2024
It is time for pharma/biotech manufacturers to consider a new approach to capacity management, one that can not only resolve today’s challenges but also position the enterprise to drive innovation and resilience in the future. You can leverage a smart manufacturing approach in three vital ways.
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How To Speed Up Time To Market With CMC Knowledge Management
1/24/2024
Poor knowledge management delays regulatory approval and, thus, market access. Here's the first in a series examining the complexity of knowledge management for CMC and across the value stream.