BIO From The Editor and Guest Columns
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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.
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Designing Highly Agile Bio/Pharma Manufacturing Facilities
4/5/2024
In bio/pharma, agile manufacturing is achieved through multipurpose designs that support a variety of unit operations manipulated and operated as independent yet connected modules.
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Who The Heck Designed This Biopharm Plant?
4/1/2024
The Bozenhardts have seen some absurd, expensive facility design errors in their work. They talk about some of the worst ones here so you can avoid the same mistakes.
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How Continuous Bioprocessing Is Shaping Modern Biopharma Manufacturing
3/28/2024
Continuous processing adoption so far has been slow; however, market research shows demand and capacity will grow significantly over the next four years.
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Best Practices For Clinical Supply Chain Management In Rare Disease Trials
3/27/2024
A supply chain pro discusses three of the greatest challenges in clinical trial supply management for rare diseases and strategies to overcome them.
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A Quality-Led Approach To Drug Production Facility Design
3/26/2024
There are important considerations that architects and engineers can miss if they don't include the quality perspective. It's better to involve quality at the outset rather than discover omissions when it's too late.
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Quick Takes From Takeda Austria’s Annex 1 Rollout
3/25/2024
At ISPE's 2024 Aseptic Conference, Takeda Austria's site head spoke about lessons learned from Annex 1 implementation. We caught up with her and asked for the highlights.
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Navigating Grades And Sources Of Materials In Drug Manufacturing
3/22/2024
From raw materials to finished dosage forms, understanding material quality is essential in drug manufacturing. This article examines how material grades and sources guide selection for optimal safety and functionality.
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Fine-tuning Analytical Development Strategies For Every Phase
3/22/2024
Analytical challenges morph phase-by-phase during drug development. Three Novartis scientists describe a platform approach based on guidance from the ICH and USP.
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Improving AAV Purity Upstream With PCL Manufacturing
3/21/2024
The downstream separation of AAV capsids affects end-product purity and has been identified as a key pain point of the industry. Ultragenyx’s Dennis Huang advises starting with higher-quality yields upstream.