Experts at PMWC 2026 emphasized that regulatory‑grade real‑world data in oncology will require prospectively collected, harmonized datasets that integrate multimodal clinical information.
- Trends In FDA FY 2025 Warning Letters
- SUS Interchangeability Assessment And Qualification Best Practices
- Delivery Strategy For Next-Gen Cardiac Gene Therapies
- Accelerating Technology Diffusion In Cell And Gene Therapy
- The In Vivo Cell Therapy Shift On Display At PMWC 2026
- Inside SynaptixBio's Mission To Develop A Therapy For H-ABC
- 5 QMS Blind Spots You Should Know About
- New MIT Consortium Links Innovation With Real-World Biomanufacturing
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Ensuring Viral Safety Through Multiplexed Adventitious Virus Detection
Gain a targeted look at multiplex digital PCR that detects diverse human viral contaminants with speed, sensitivity, and precision. Learn how high‑multiplex workflows support QC needs.
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Enhanced Flow Kit Performance With Leak And PUPSIT Testing
Sterile drug filtration demands rigorous integrity testing to prevent contamination. Learn how PUPSIT and in situ leak testing strengthen compliance with EU GMP Annex 1 and ensure reliable manufacturing.
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Comparing Process Development Approaches For Recombinant Proteins
Explore how adding a traceless tag enables streamlined affinity purification for recombinant proteins, and how this approach compares with a conventional process in development time, recovery, and purity.
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Production And Clarification Of Lentiviral Vectors
Explore scalable processes for lentiviral vector production and clarification at the 50 L scale, utilizing the CTS LV-MAX system and single-use bioreactors for robust gene therapy manufacturing.
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Enhanced Validation Data Anti-EGFRvIII Recombinant Antibody
Select the right antibody clone by exploring enhanced validation data for top recombinant antibody clones that offer comprehensive specificity and sensitivity insights tailored to your project's unique requirements.
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Business Continuity Management: The Benzonase® Endonuclease Success Story
Business continuity management is a key success contributor to the pharma industry. Explore best practices for a robust supply chain and how they can translate into success stories.
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The State Of Digital Maturity In Pharma And Medtech Manufacturing
Explore results from a study aiming to understand why numerous companies continue to rely on manual, paper-based systems, and gain insight into how your competitors are gaining a competitive advantage.
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Enhancing CRISPR Knock-In And Knock-Out
Achieve scalable, non-viral CRISPR delivery for T cells. The next-generation electroporation platform provides robust, efficient gene editing in large-scale volumes.
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FDA's Regenerative Medicine Advanced Therapy (RMAT) Program
RMAT qualification requires preliminary clinical evidence demonstrating the potential to address an unmet medical need. This designation grants benefits like intensive guidance and faster FDA review.
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The Key To Viral Vector Success
Establishing a robust and scalable viral vector process requires a multidisciplinary approach that incorporates expertise in foundational science, analytics, and biomanufacturing.
NEWSLETTER ARCHIVE
- 03.14.26 -- Cell & Gene Best Of February
- 03.13.26 -- Green Supply Chains Rarely Start With A Pledge; Target Waste Instead
- 03.12.26 -- Six Specialized Modalities Testing CDMO Readiness In 2026
- 03.11.26 -- Are You Scaling CGT Wrong?
- 03.11.26 -- Regulators Maintain Consistent Endpoints While Raising Evidence Standards
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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