Industry Insights
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Adapting Clinical Supply Strategies Through The Phases
5/17/2024
Phase-appropriate logistics are essential to manage resources efficiently, maintain regulatory compliance, and ensure timely delivery.
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How To Unlock Efficiency In MES Integrations
5/16/2024
This article outlines the significant benefits and framework for manufacturing execution system (MES) integration with systems such as enterprise resource planning.
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How Advanced PAT Aids Quality By Digital Design In mRNA Manufacturing
5/15/2024
QbDD is an improvement over the QbD paradigm. Here, computational models are used to characterize, monitor, control, and improve manufacturing processes.
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Gene Therapy: How Should We Approach Benefit And Risk?
5/14/2024
Understanding the benefit-risk ratio is a complex exercise for gene therapies, where there hasn't been sufficient time to understand the long-term risks. How should we approach it?
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Trends To Track: Outbound, Inbound Biopharma Supply Chain Advances
5/10/2024
Here's an overview of advancements in technology and industry built around biopharmaceutical supply chain and logistics, including packaging and temperature controls.
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CGTs for HIV Suppression with Addimmune's Dr. Marcus Conant
5/9/2024
On this episode of Cell & Gene: The Podcast, Addimmune CMO, Dr. Marcus Conant, shares the why behind cell and gene therapy to treat HIV, and he explains the company's lead asset, AGT103-T, which is designed to provide broad protection using silencing RNA to inhibit binding/entry of the virus, halt replication, and prevent escape.
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Gene Therapy: Global Market Trends & Notable Developments
5/8/2024
New market research about the gene therapy market from Markets And Markets reveals insights into macro trends, delivery methods, therapeutic areas, and more.
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Addressing Challenges In Serialization For Complex Therapeutics
5/7/2024
The magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.
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Evaluating, Validating, And Implementing NAT-Based Mycoplasma Detection Methods
5/3/2024
Regulatory 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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New Initiative Seeks To Back Up ICH's Harmonization Mission
5/3/2024
An inaugural survey revealed that a lack of harmonized regulations slows the advancement of alternative drug modalities and advanced manufacturing technology.