Here's why strong material selection, risk-based controls, and early analytics are critical for successful CGT development.
- 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
- Compliance, Costs, And Site Readiness In CAR-T Clinical Trials
- All The Ways Global Biopharma Still Grapples With Annex 1
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
10 Clinical Research Practices That Feel Like Compliance (But Aren't)
Many clinical research routines are driven by habit, not regulation. This guide clears up 10 common misconceptions to streamline workflows and reduce unnecessary admin work.
-
Enhanced mAb Production With High-Intensity Perfusion CHO Medium
Reach new heights in mAb production with a high-intensity perfusion CHO medium designed to support consistently high product yield and quality in continuous perfusion cultures using CHO-K1 cells.
-
ATMP Cryopreservation Done Right - Best Practice In Small Volume Cryo-Freezing
Explore best practices for cryopreserving small-volume advanced therapy medicinal products (ATMPs), emphasizing sterility, cell viability, and efficiency using innovative single-use systems and aseptic connectors.
-
Collaborative Variability Reduction In Cell Culture Media
Variability reduction programs improve biomanufacturing by controlling raw‑material complexity, optimizing critical attributes, and boosting productivity through data‑driven partnerships.
-
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.
-
ICH E6(R3) In Effect: Transforming Quality Management For CGT Trials
Discover how the updated ICH E6(R3) guideline supports the speed and complexity of CGT manufacturing, enabling flexible, risk‑based decisions and quality systems built to scale therapies safely.
-
Fill-Finish Contract Manufacturing: Trends, Challenges, And The Future
See why it's important to partner with a CDMO that’s investing in advanced sterile fill-finish capabilities to meet the demands of complex biologics, gene therapies, and mRNA-based products.
-
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.
-
Phase-Appropriate Approaches To Manufacturing And Testing
Accelerate the development of high-quality biopharmaceuticals by implementing phase-appropriate, risk-based manufacturing and testing strategies that ensure timely progression.
-
Mixing Of Various Dry Powdered Media And Buffers
Explore how this mixing system efficiently handles various powdered media and buffers, ensuring precise solubilization and mixing in applications like cell culture and protein purification.
NEWSLETTER ARCHIVE
- 03.24.26 -- STREAM Edition: AI-Designed Logic Circuits For Smarter Cancer Targeting
- 03.24.26 -- Delivery Strategy For Next-Gen Cardiac Gene Therapies
- 03.23.26 -- 5 QMS Blind Spots You Should Know About
- 03.20.26 -- Lessons From Bringing A New T Cell Class For Autoimmune Diseases To Clinic
- 03.19.26 -- Your Guide To AAV Success: Characterization, QC, And Viral Clearance Strategies
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