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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Physiologix™ Serum Replacement Performance On Mesenchymal Stem Cells
Learn about the effectiveness of a xeno-free serum replacement in mesenchymal stem cell (MSC) culture and its potential to enhance cell growth and reduce variability compared to fetal bovine serum.
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Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends
Review contract manufacturing's evolution, driven by technological advancements and regulatory changes, and how CMOs and CDMOs are navigating opportunities and challenges.
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The True ROI Of Decentralized Clinical Trials
Gain a greater understanding of how the right DCT solution, or combination of solutions, coupled with clear metrics and expert guidance on execution, can demonstrate tangible, quantitative ROI in clinical trials.
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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.
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Quality Assurance In IVT RNA Vaccine Development Using Electrophoresis
Discover advanced solutions for IVT RNA synthesis, focusing on enhancing fidelity in throughput, innovative technologies, and methodologies to optimize your RNA research and development processes.
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Predicting Antibody-Dependent Cell-Mediated Cytotoxicity
We developed and validated a dual screening procedure (genotype and phenotype) for Lonza human peripheral blood mononuclear cells (PBMCs) to identify donors with high ADCC potential.
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Phase 1 Clinical Trial Designs And Strategies
With tailored guidance, sponsors can align their modern model-based and model-assisted design choices to program goals, accelerating progress while safeguarding patients.
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Implementing Raman Spectroscopy For Automated Monitoring Of A Cell Culture Bioprocess
Discover how Raman spectroscopy and parallel bioprocessing enable real-time cell culture monitoring, saving time and providing crucial data for process optimization in biopharmaceutical production.
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Rapid Walkaway Solution For Assessing Viability In Cancer Organoids
Assess anti-cancer compounds' effects on organoid size and morphology with colorectal cancer organoids as well as discover automated imaging and viability assays to streamline drug screening and aid early identification.
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Partner Case Study: Accelerating Gene Editing Manufacturing
Beam Therapeutics partnered with ElevateBio to manufacture BEAM-101, a novel base editing therapy for sickle cell disease, advancing rapid, high-quality production towards clinical trials.
NEWSLETTER ARCHIVE
- 04.27.26 -- March 2026 — CDMO Opportunities And Threats Report
- 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
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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