Guest Columns & From The Editor
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Nanoscope Therapeutics Tackling Vision Loss With Ocular Gene Therapy
3/27/2024
Leaders from Nanoscope Therapeutics explain the safety and efficacy data from as well as next steps for the company's RESTORE trial.
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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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ICYMI: Q1 2024’s Cell & Gene Live And Cell & Gene: The Podcast
3/27/2024
With Q1 of 2024 coming to close, I wanted to take this opportunity to make sure you’ve read, heard, or viewed some of insightful content we’ve created for Cell & Gene's readers since the start of the year.
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Inside Tenaya Therapeutics’ AAV9-Based Gene Therapy
3/27/2024
Tenaya Therapeutics' CSO explains how the company's gene therapy, TN-401, may treat heart disease.
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The Role Of Behavioral Science In Improving Cell & Gene Therapy Adoption
3/27/2024
There is still a lot of work for cell and gene therapy developers to do to promote their uptake. How might behavioral science help?
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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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Reducing The Number Of Clinical Holds On Cell And Gene Therapies: Approaches For Sponsors And The FDA
3/25/2024
There is a large proportion of clinical trials for cell and gene therapies that the FDA places on clinical hold. Why is this, and what can sponsor companies and the FDA do differently?
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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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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.