The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.
- Zymeworks Shares Its Design Rationale (And Wins) In Early-Phase ADC Trials
- Ever Wonder What Running A $50B Capital Facilities Project Feels Like?
- Generative AI Can Write The Code, But Who Builds In The Quality?
- From "Live Drug" To Precision Tool: Redefining CAR T Safety
- UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk
- February 2026 — CDMO Opportunities And Threats Report
- COGs And Biology, Two Endpoints Needlessly At Odds In Advanced Therapy
- The Long Road To U.S. Vaccine Manufacturing
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Multiplex Imaging
Explore recombinant antibody reagents that support the imaging of key targets within the TME and offer flexible solutions across various platforms to improve patient outcomes.
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Aggregation In Antibody-Drug Conjugates: Causes And Mitigation
Discover how early intervention in ADC development can streamline clinical progress, ensure stability and safety, and accelerate commercialization with expert guidance.
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TFF Cassettes With 100 kDa Membranes For RNA And LNP Applications
This study showcases the performance of regenerated cellulose flat sheet membranes with a 100 kDa molecular weight cutoff for UF/DF of RNA molecules by TFF.
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Overcoming Rapid Growth Challenges With Process Liquid Preparation
With a helpful assessment and the right process liquid preparation services, the CDMO featured in this study was able to find a path toward meeting the surge in demand for a client's therapeutic .
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IVT mRNA Encapsulation Efficiency Assessment
In vitro transcribed mRNA revolutionizes biotherapeutics, which necessitates thorough quality assessments. See how an analyzer system enhances encapsulation efficiency and CQAs in IVT mRNA workflows.
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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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Handle Single-Use Technology Biopharma Waste: Data Sharing, Collaboration
Learn more about data sharing and collaboration to enable a better environmental impact of single-use technologies (SUTs) and quantifying the single-use plastic waste generated when manufacturing mAbs.
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Scale-Up Approaches For Culturing Adherent Cells
For successful scale-up, see how optimizing process parameters such as attachment methods, gassing, and agitation can help reduce cell environmental stress, ultimately improving productivity.
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Industry-Leading Advanced Therapy Support Revolutionizing Transport
Learn about a validated dry ice shipping system that fills a critical gap in the life sciences industry and is revolutionizing the transport of high-value commodities such as advanced therapies.
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Navigating The CGT Landscape: Key Takeaways From The FDA's New FAQ
The FDA's new FAQ on cell and gene therapy offers a roadmap for developers. Review key insights from the document, including the importance of early engagement with the FDA, CMC considerations, and more.
NEWSLETTER ARCHIVE
- 03.27.26 -- Accelerating Technology Diffusion In Cell And Gene Therapy
- 03.26.26 -- The Hidden Obstacles Stalling Advanced Therapies
- 03.26.26 -- FDA's 483 Playbook: What It Means And Misses For Pharma Outsourcing
- 03.25.26 -- A simple, helpful look at PUPSIT implementation.
- 03.25.26 -- Building Harmonized Real‑World Data In Oncology
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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