The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.
- Zymeworks Shares Its Design Rationale (And Wins) In Early-Phase ADC Trials
- Ever Wonder What Running A $50B Capital Facilities Project Feels Like?
- Generative AI Can Write The Code, But Who Builds In The Quality?
- From "Live Drug" To Precision Tool: Redefining CAR T Safety
- UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk
- February 2026 — CDMO Opportunities And Threats Report
- COGs And Biology, Two Endpoints Needlessly At Odds In Advanced Therapy
- The Long Road To U.S. Vaccine Manufacturing
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Redefining The Analytical Frameworks Surrounding Capsid Characterization
Modern AAV manufacturing demands precise capsid characterization to distinguish empty, partial, and full particles, as regulators now require rigorous purity and potency control for clinical safety.
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Why Biopharma Breakthroughs Aren't Moving The Market
Biopharma is innovating fast but falling short commercially. Reveal key ecosystem gaps and five strategic actions to help strengthen resilience, accelerate performance, and futureproof organizations.
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A Human-Relevant Model Of The Liver Sinusoid
This organ-on-a-chip model minimizes drug absorption while maintaining the essential architecture. Explore the specifications of this product engineered to model the human liver.
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Media Exchange In iPSC Cell Expansion And Differentiation: A Comparative Study
Low-shear, closed-system media exchange in iPSC differentiation is vital for scalability. This study compares automated centrifugation to gravity sedimentation, showing equivalent or superior differentiation outcomes.
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A Transient Cell Line To Produce rAAV With Low-Level hcDNA Encapsidation
Discover the ability of a novel HEK293 suspension cell line for efficient and scalable rAAV production across various serotypes with low encapsidated host cell DNA levels.
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Expansion Of Human Umbilical Cord-Derived MSCs
Discover how high-quality, multipotent stromal cells are efficiently produced for regenerative medicine. Learn about their impressive viability and critical marker expression for therapeutic uses.
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Best Practices For Analysis Of IVT mRNA
Discover how an automated capillary electrophoresis system provides robust and precise integrity, concentration, and size analysis for IVT mRNA.
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Predicting Human Liver Damage With A More Accurate In Vitro Hepatotoxicity Assay
This study explores whether a species-specific, multicellular, in vitro hepatotoxicity assays utilizing Liver-Chips can provide a greater understanding of hepatotoxicity mechanisms than animal models.
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Expert Insights In Navigating CGT's Complex Supply Chain
Examine insights shared during Cencora's ThinkLive Cell and Gene Therapy Summit 2024 that shed light on the challenges and opportunities in navigating the complexities of the cell and gene supply chain.
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The Proven Supplement For CAR-T Solid Tumor Cytotoxicity
Optimize cell culture for solid tumor research. Replacing traditional serum can significantly enhance CAR-T cytotoxicity, improve consistency, and streamline the path to GMP-ready workflows.
NEWSLETTER ARCHIVE
- 03.30.26 -- The Long Road To U.S. Vaccine Manufacturing
- 03.27.26 -- Accelerating Technology Diffusion In Cell And Gene Therapy
- 03.26.26 -- The Hidden Obstacles Stalling Advanced Therapies
- 03.26.26 -- FDA's 483 Playbook: What It Means And Misses For Pharma Outsourcing
- 03.25.26 -- A simple, helpful look at PUPSIT implementation.
CELL AND GENE CONTENT COLLECTIONS
While there are opportunities to scale, there are also manufacturing gaps, capacity issues, and production timelines that require improvement to do so. And then, of course, there’s cost. Because scale up and scale out are significant to everyone in the sector, we’ve curated insightful editorial that addresses the most important aspects of scalability.
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