Featured Bioprocessing Editorial
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Factors To Consider When Licensing An ADC Program
1/30/2024
Elevation Oncology's CEO and CSO explain what made the company's lead ADC candidate, EO-3021, worth licensing from Chinese pharmaceutical company, CSPC.
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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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Tangential Flow Filtration 101 — The Tech, The Need, And The Market
1/26/2024
Here's a high-level summary of what is increasingly becoming an essential part of the downstream bioprocessing production line.
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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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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FDA Issues Draft Guidance For Cell & Gene Therapy Potency Assurance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The FDA recently released a draft guidance, Potency Assurance for Cellular and Gene Therapy Products. This article summarizes the draft guidance.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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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.
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Developing A Viral Gene Therapy Manufacturing Process
1/23/2024
There is a growing popularity of adeno-associated virus (AAV) for delivering in-vivo gene therapies, a growing preference of transient transfection systems by biologics companies, and an increasing number of CDMOs offering this system as a platform process. This article describes a transient transfection AAV manufacturing process that uses a triple plasmid transfection strategy into HEK293T cells.
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Tracking 4 Payload Trends In Drug Delivery Development
1/22/2024
Amid new research and development in nanocarriers, market attention has shifted toward payloads and enhancing compatibility. This discussion explores the latest trends and includes a research database.