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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Next Generation Sequencing In Viral Safety Testing
Next Generation Sequencing (NGS) offers a sensitive, high-throughput solution for detecting adventitious viral agents (AVAs), improving biopharmaceutical safety and accelerating regulatory-compliant product development.
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Correlating NGS Success With Sample Input Quality: A Large Scale Study
DIN values offer a data‑backed way to identify which DNA samples are ready for successful sequencing. With strong correlations to sequencing performance, DIN thresholds help streamline workflows.
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Master The Art Of Pipetting And Learn How To Perform Serial Dilutions
Accurate serial dilutions depend on more than calculations. Learn how mixing, tip handling, and workflow consistency influence accuracy, as well as how small adjustments can improve reproducibility.
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Smart Scaling For Cell And Gene Therapies
To meet patient demand, advanced therapy manufacturing processes must be commercial ready. CGT sponsors can mitigate risk and protect viability by partnering with a CDMO that prioritizes scalability.
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Lentiviral Vector Characterization For Cell And Gene Therapy Manufacturing
This study focuses on characterizing recombinant LVVs used in gene-modified cell therapies, utilizing two real-time PCR assays adapted to the QuantStudio™ Absolute Q™ Digital PCR System.
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Maintain Sterility And Ease In CGT Development, Including Cryopreservation
Sterile connectors streamline cell and gene therapy processes while maintaining sterility. By withstanding extreme temperatures and cryoprotectants, they can ensure product viability during cryopreservation.
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Aseptic Filling Solution Enhances Sterility Assurance for Pharma Manufacturer
Emergent BioSolutions upgraded its Winnipeg site with the Cytiva SA25 aseptic filling workcell to improve sterility assurance, product flexibility, and regulatory compliance for CGT manufacturing.
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Make Your Production Sites Adaptable And More Efficient
Pharma faces mounting complexity and tighter margins, demanding agile, future-ready production. Discover how smart manufacturing enables faster adaptation and continuous therapy availability.
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Smart Manufacturing: A Strategic Imperative For Pharma's Future
Pharmaceutical manufacturing is evolving rapidly. Find out how digital technologies like AI, digital twins, and software-defined automation are driving smarter, more agile production.
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Unlock 14% Reduction In AAV Gene Therapy Cost Of Goods
Comparing plasmid DNA to enzymatically produced DNA shows how enzymatic methods cut manufacturing costs, speed production, and boost efficiency for large‑scale AAV gene therapy.
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.
More Content Collections