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| Webinar: Overcoming Regulatory Hurdles in AAV Production | As CGT advances, regulatory expectations continue rising—especially around demonstrating clearance of residual reagents in viral vector production. In this webinar, Miguel Dominguez and Lloyd Achirem from Mirus Bio (part of MilliporeSigma) share how strategic partnerships and a newly developed residual reagent assay simplify submissions and strengthen quality assurance. Learn how their practical innovations support more efficient, compliant, and future-ready AAV manufacturing. Click here to learn more. |
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By Erin Harris, Editor-In-Chief, Cell & Gene | Early manufacturing choices in cell and gene therapy shape long-term clinical and commercial success, so leaders from Allogene and Verismo emphasized that both autologous and allogeneic developers should prioritize process simplicity, risk-based decision-making, and adaptable manufacturing as therapies move from concept to clinic. | |
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| 2026 Trends With Single-Use Bottles In Bioprocessing | Q&A | Single Use Support | Despite the rise of single-use bags, bottles continue to play a significant role in bioprocessing for the production of robust products. New closed-system technologies and sustainable materials could boost their popularity. |
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| Plan And Optimize Your Western Blot Experiments | e-book | Danaher Life Sciences | Western blotting identifies specific proteins in complex samples, using gel electrophoresis and antibody probing. Find out how it reveals protein presence, abundance, and size. |
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| The Shift To GMP-Compliant Automation In CGT Manufacturing | Article | 3P innovation | Manual processes are yielding to automated, GMP-compliant closed systems in CGT manufacturing. This shift is crucial for meeting Annex 1 contamination standards and creating scalable, reliable commercial production. |
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| Enabling MSC Harvest, Wash, And Concentration | Case Study | CARR Biosystems | A study demonstrates how a low-shear, closed-system centrifuge achieved over 90% MSC recovery and minimized viability loss, supporting scalable cell therapy manufacturing. |
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| What Is A Viral Vector? | Article | Cytiva | Review a novel adenovirus production process that offers scalable, single-use equipment-compatible solutions, reducing production time and cross-contamination risks. |
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| Vial Containment Systems For Gene Therapies: Container Closure Integrity | Article | By Margaret A. Craig, Rui Li, and T. Page McAndrew, West Pharmaceutical Services | Maintenance of CCI at ultra-low temperature is a necessity for a gene therapy vial containment system. Systems comprising cyclic olefin polymer vials and elastomer stoppers with a barrier film were evaluated over time. |
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| Enhancing CRISPR Knock-In And Knock-Out | Application Note | Lonza | Achieve scalable, non-viral CRISPR delivery for T cells. The next-generation electroporation platform provides robust, efficient gene editing from small to large-scale volumes. |
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| Studies On CHO Cell Culture In X-ray Single-Use Bioreactors | Application Note | By Nathalie Chandelier, Muriel Art, et al., Eppendorf SE | In cell culture, the leakage of toxic or inhibitory chemicals from single-use bioreactors has become a growing concern. Explore recommendations for leachable studies. |
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| Rev-Up AAV Genome Production In Upstream Manufacturing | Application Note | By Becky Reese, Jennifer Swanson, Austin Storck and Laura Juckem, Mirus Bio | By increasing recombinant AAV titers, this AAV enhancer can help reduce upstream manufacturing costs and lower the cost per therapeutic dose. |
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| Join us for this Cell & Gene Live when Erin Harris, Chief Editor of Cell & Gene welcomes Steve Awad, Principal Director, Supply Chain & Industry X — Life Sciences at Accenture, and Michael Blackton MBA, VP, Manufacturing and Supply at Ocugen to unpack what CGT developers need to know about efficient, compliant dual- or multi-modal manufacturing even when production is outsourced. Registration is free thanks to support from Ecolab Life Sciences. |
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