Guest Columns
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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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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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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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A Guide To Proactive Supplier Management In The Pharma/Biotech Industry
3/21/2024
Proactively mitigate supply disruptions with strategic supplier selection and diversification, effective communication, risk management, quality assurance, and more.
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How To Measure Cell Density In Real Time With Soft Sensors
3/21/2024
Soft sensors can enable real-time monitoring of key process variables, including viable cell density. Here's how one team at Takeda put them to use.
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How To Prevent And Manage Temperature Excursions In Clinical Trials
3/20/2024
Temperature excursions can have devastating effects on drug product for clinical trials. Here are some ways to avoid them and protect the cold chain.
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Process Development With “The End In Mind” For Startups
3/20/2024
We encounter the term “the end in mind” in product development frequently, but many are unsure what it really means and when it matters. This article sheds light.
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Considerations For Robust Implementation Of The Multi-Attribute Method
3/19/2024
USP experts explore implementation strategies for the multi-attribute method, including best practices summarized from the USP’s General Chapter <1060>.