Featured Editorial
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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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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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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.
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NK Cell Therapies: How Artiva Biotherapeutics Leverages Its "Manufacturing First" Approach
4/24/2024
We caught up with Chris Horan, Artiva Biotherapeutics' CTO, to discuss natural killer cell therapies and Artiva’s experiences and strategies with its candidate, AlloNK.
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Improving Governance And Compliance With Knowledge Management
4/23/2024
Knowledge management — it’s not just a soulless exercise. In the last part of his series, Hirsh helps bridge the gap between compliance and business needs.
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Cell Counting Is Growing More Important Amid Advanced Therapy's Rise
4/12/2024
You can't improve what you don't measure. This discussion explores advances in cell counting technology and the growing number of ways it aids the biotech industry and beyond.
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FDA Publishes Final Guidance On Reporting Listed Drug Amounts
4/10/2024
Despite earlier efforts to shore up the U.S. drug supply chain, COVID-19 still brought shortages. A new FDA reporting system aims to reduce future supply risks.
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Digitizing CMC Knowledge Management
4/8/2024
Systems that enhance know-how retention stretch from utterly simple to enterprise-scale. Here are some ideas for incorporating them into your knowledge management strategy.
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When Does GMP Matter In Non-GMP Settings?
4/5/2024
Would you ever need to follow GMP standards in workspaces where GMP is not required or possible? This article digs into why, when, and how to follow the principles of GMP.
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What Really Happens When A Cell Therapy Supply Chain Fails?
4/5/2024
A freezer left unpowered can have devastating effects on delicate supply chains. These true stories led to tough lessons for biotech companies producing personalized medicine.