Cell and Gene Regulatory
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Restore Control When It Matters Most
3/19/2026
Act with certainty during contamination events. Learn a proven four-step process to identify root causes, restore environmental control, and implement effective CAPAs to prevent recurrence.
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The Hidden Costs Of Paper Logbooks
3/19/2026
Stop losing time and capacity to manual paperwork. Learn how digital workflows eliminate compliance risks and unlock the actionable data needed to optimize life sciences manufacturing.
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Integrated Contamination Control Solutions For Biopharma
3/19/2026
Unlock higher yields and ensure regulatory success with a tailored process optimization program designed to eliminate contamination risks and stabilize biopharmaceutical workflows.
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Materials Matter: Ensuring Quality Of CGT Materials
3/19/2026
Cell and gene therapies are only as strong as the materials behind them; from plasmids and viral vectors to cytokines and other critical components, subtle quality issues can quietly derail promising programs. In this Cell & Gene Live, Anthony Blaszczyk, Ph.D., Senior Scientist at the U.S. Pharmacopeia, and Basak Clements, Ph.D., Founder and Senior Advisor at biomatria, joined Cell & Gene Chief Editor Erin Harris to unpack what today’s CGT leaders need to know about raw, starting, and ancillary materials.
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All The Ways Global Biopharma Still Grapples With Annex 1
3/19/2026
Biopharma companies can't consistently meet Annex 1 expectations. At the heart of the problems, regulators have shifted the burden of proof to manufacturers.
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Empower Your Studies With Our Expertise
3/18/2026
Look at how optimized virus banking strengthens manufacturing by enhancing consistency, speeding characterization timelines, and aligning testing strategies with modern regulatory expectations.
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Integrated Quality, Regulatory, And Safety Services
3/18/2026
A single-vendor model for quality, regulatory, and safety services provides consistent project management and cost-effective scalability. Hear how integrated solutions support market entry and growth.
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Industry Innovators: APAC's Sharp Advanced Therapeutics Edge
3/17/2026
APAC is rapidly advancing its role in the global therapeutics landscape, fueled by faster development models. Learn how this momentum is reshaping expectations for innovation and commercialization.
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Why Manufacturing Drives FDA CRLs In Cell Therapy
3/17/2026
Manufacturing and quality gaps drive most FDA Complete Response Letters in cell therapy, often stemming from early‑stage decisions and unresolved CMC issues that become major late‑stage approval risks.
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A Faster Path To Genomic Medicine Feasibility
3/17/2026
Life Edit accelerates genomic medicine by comparing five editing modalities, engineering new enzymes, and rapidly pinpointing optimal strategies that boost feasibility, cut risk, and speed clinical progress.