Fixing limited capacity in pharmaceutical CMC development starts with understanding a complex web of root causes.
- In Vivo LNP-Engineered Cytokine-Armored CAR Cells For Solid Tumors
- CGT Industrialization Starts With CDMO Alignment
- Powering Cell Therapies With RNA: A New Code For Engineered Immunity
- Why Efficiency In Multi-Modal CGT Manufacturing Is About Execution, Not Just Cost
- Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis
- November 2025 — CDMO Opportunities And Threats Report
- 2025's Top 5 Drug Discovery Highlights And How To Stay Ahead In 2026
- What 2025 FDA Warning Letters Tell Us About GMP Compliance
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Unraveling The Complexity Of Cell Therapy: Advancements And Challenges
Cell therapy has emerged as a powerful tool for addressing critical medical challenges, but its rapid evolution necessitates a clear regulatory framework and consistent terminology.
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The Value Of Peptones For Cost-Effective Vaccine Manufacturing
Peptones offer a strategic solution to key biomanufacturing challenges by enhancing cell culture performance, improving yields, and reducing production costs.
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Performance Of HEKima™ Adherent HEK Cell Medium
Explore the performance of a serum-free medium designed for HEK-293 cells, comparing its efficacy to traditional media for protein expression and cell proliferation.
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Redefining Accessibility For Pediatric Patients
Explore how meeting patients where they are can redefine what successful pediatric trial delivery looks like.
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Non-Viral Genetic Modification Using The 4D-Nucleofector LV Unit In CGT
This paper underscores the 4D-Nucleofector® LV Unit as a pivotal tool for translating genetic modification technologies into scalable, safe, and effective therapeutic solutions.
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Muscular Dystrophy: Multi-National And Multi-Site Trials
Learn about the success ReveraGen found when expanding their partnership with Novotech to a larger phase 2b trial (VBP15-004) in Duchenne Muscular Dystrophy (DMD).
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Enhancing Safety And Efficacy Of mRNA-Based Therapeutics
Discover how Codex® HiCap RNA Polymerase optimizes mRNA yield while reducing dsRNA byproducts for safer, more effective therapeutics.
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Development Of LNP Formulations Using The KNAUER NanoScaler
Lipid nanoparticles (LNPs) offer a robust solution for nucleic acids. The NanoScaler system optimizes this technology, enabling scalable and reproducible LNP formulations for diverse applications.
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Optimizing siRNA Therapeutics: Addressing Manufacturing Complexities
Discover key strategies to optimize siRNA therapeutics by addressing critical nonclinical and manufacturing challenges for a smoother path to commercialization.
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Immunophenotyping Of Normal Whole Blood Using A 12-Color BD Horizon™ Chroma Research Panel On The BD FACSDuet™ Premium Sample Preparation System Integrated With The BD FACSLyric™ Flow Cytometer
In this study, a fully automated workflow utilizing the BD FACSDuet™ Premium Sample Preparation System integrated with the BD FACSLyric™ Flow Cytometer was assessed and compared to manual processing.
NEWSLETTER ARCHIVE
- 01.02.26 -- Building Supply Chain Resilience When Dual-Sourcing Isn't An Option
- 12.23.25 -- STREAM Edition: Engineering B Cells With Immusoft's Sean Ainsworth
- 12.23.25 -- Why Do So Few Cell Therapies Make The Leap From Lab To GMP?
- 12.22.25 -- Cell & Gene Therapy Outsourcing's New Paradigm
- 12.19.25 -- Viability On The Line: Defining Minimum Quality For CGT Raw Materials
- Why Efficiency In Multi-Modal CGT Manufacturing Is About Execution, Not Just Cost
- CSL's HEMGENIX Shows Durable Benefit, A New Future For Gene Therapy in Hemophilia B
- Cell 2025, Advanced Therapies USA Taught Me Why Platformization Is No Longer Optional
- Why Early Manufacturing Decisions in Cell & Gene Therapy Matter
- How Early Manufacturing Decisions Shape Long-Term Success
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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