Cell and Gene Regulatory
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How To Implement Three Cleaning Best Practices For Your Cleanroom
3/28/2024
Learn about the three cleaning best practices that will make a difference in your cleanroom, the importance of each step, and how to implement these strategies.
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Gain Support For Your Regulatory Submission Process
3/27/2024
Join us in this video as we delve into invaluable tips, cutting-edge tools, and unwavering support that Cytiva offers to facilitate your documentation progress.
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Cell Therapy Process Development Made Easy
3/27/2024
Explore how Fast Trak™ process development services offered by Cytiva can guide you through achieving GMP compliance in your cell therapy manufacturing process.
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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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Challenges Associated With Building New Isolator Technology
3/26/2024
Paula Rizo, Germfree’s Mechanical Engineering Lead for Equipment, dives deeper into our collaboration with AST and how this isolator technology will transform the way pharmaceutical companies approach aseptic processing.
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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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A Regulatory Perspective: How Government Funding Spurs Scientific Innovation
3/25/2024
Review the different ways the United States government supports alternative, innovative approaches for more reliable readouts of toxicity and efficacy.
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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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CMC And Regulatory Considerations For CRISPR Therapies
3/21/2024
This article explores the details of Chemistry, Manufacturing, and Controls and Critical Quality Attributes, which play an important role in gene editing.