Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.
- Validating Candel's BLA-Ready Analytics Profile
- Mapping Candel Therapeutics' Sprint To The BLA Finish Line
- Why Cell And Gene Therapies Break After Early Success
- AI, Digitalization, And In Vivo Programming Redefine Cell And Gene Therapy
- Lilly's Unified Mindset For A Global Parenteral and Device Manufacturing Network
- Reprogramming T-Cell Access To Solid Tumors Through Improved Trafficking And Entry
- Why A Cell Therapy CEO Waited Until Phase III To Outsource
- Field Notes: APEC RHSC's Workshop On ATMP Development And Evaluation
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Redefining Biomanufacturing For Personalized Cancer Vaccines
Personalized cancer vaccines need fast, flexible manufacturing. Cell‑free synthetic DNA enables rapid, small‑batch mRNA production, supporting individualized therapies beyond plasmid‑based limits.
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Leveraging Single-Use Solutions To Solve Working Cell Bank Challenges
Discover how custom manifolds enhance allogeneic therapy development from formulation to commercialization by improving process control, scalability, and efficiency.
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Maximizing MSC Yield And Quality: A Comparative Media Study
Maximize mesenchymal stem cell (MSC) expansion with a simplified culture process. New data demonstrates a high-performance, xeno-free media that eliminates the need for coatings or media exchanges.
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Unlocking Recruitment Potential In Trial-Naïve Sites
Site Professional Support enabled this late-phase rheumatoid arthritis study to conduct complex patient visits despite its use of sites that lacked research experience and resources.
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Forget About Isolators: Switching From Manual Vial To Automated Bag Filling
Discover how transitioning from manual vial filling to single-use bag systems can reduce contamination risk, improve accuracy, and enhance GMP compliance in biopharmaceutical manufacturing.
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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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How Lipid Nanoparticles Enable Next-Gen Delivery
Cell therapy’s future depends on smarter gene delivery. Learn how lipid nanoparticles offer a scalable, cell-friendly alternative to electroporation and viral vectors for manufacturing efficiency.
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Efficient Protein Purification Strategies
Examine two rapid, high‑throughput strategies for small‑scale protein separation, using either multimodal resins or ion exchange membranes to achieve efficient, low‑volume purification.
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Biopharma Supply, Reimagined: Regional, Resilient Manufacturing
Persistent disruption is redefining biopharma supply chains. Explore how regional manufacturing, integrated risk management, and closer collaboration help build resilience and improve agility.
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Bringing Clinical Trials To Everyone's Backyard
Learn how bringing clinical trials to any community around the world is not only possible but also increases patient access and reach and improves recruitment and retention.
NEWSLETTER ARCHIVE
- 04.24.26 -- U.S. Pharma Tariffs And MFN Become Law After April 2 Update
- 04.23.26 -- Mastering Biotech's Insourcing/Outsourcing Trade-Offs
- 04.22.26 -- Building Resilient Biomanufacturing From Media To Market
- 04.22.26 -- From QM To QMM For AI-Assisted Pharmaceutical Manufacturing Operations
- 04.21.26 -- All The Ways Global Biopharma Still Grapples With Annex 1
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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