Industry Insights
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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FDA Issues Draft Guidance For Cell & Gene Therapy Potency Assurance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The FDA recently released a draft guidance, Potency Assurance for Cellular and Gene Therapy Products. This article summarizes the draft guidance.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.
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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.
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Objectively Evaluating Innovative Therapies And Making Sense Of Emerging Data
1/22/2024
Poseida Therapeutics' President and CEO, Kristin Yarema, Ph.D., details why allogenic CAR-T compares favorably with autologous CAR-T, and why, in many ways, allo has advantages that auto cannot hope to match.
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A New Year’s Resolution Suggestion For The FDA
1/22/2024
Many pharma/biotech companies have continuing compliance problems when getting inspected by our friends at the FDA. In this article, this industry observer with almost 50 years of experience shares some New Year's resolution wishes for the FDA, and, by extension, industry members can consider the list as the foundation for sustainable quality in your operations.
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Liposome Drug Delivery: Global Trends & Market Forecast
1/19/2024
Liposomes possess the ability to encapsulate drugs of both hydrophilic and hydrophobic nature. They can be tailored to target tissues or cells, enabling precise drug delivery. Let's examine how it works, applications, and new market insights.