Learn what regulators are already asking about AI, what quality must mean in this new context, and how organizations can begin building the governance infrastructure.
- The Systems And Choreography Needed For Grade B ATMP Material Transfer
- Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign
- Navigating GMP Biosafety Challenges In ATMP Manufacturing
- Ensuring Quality Of CGT Materials
- 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
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Delivering A Registrational GI Trial Through Ongoing Protocol Shifts
A biotech developing bispecific antibodies partnered with a flexible CRO to launch its first U.S. GI oncology trial, requiring strategic insight and full-service clinical support.
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Overcoming Analytical Bottlenecks In Oligonucleotide Drug Development With Automation
Growing oligonucleotide complexity is straining traditional analytical workflows. See how automated LC‑UV‑MS processing offers a scalable way to boost throughput and reduce manual effort.
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Optimization And Scale-Up Of A Plasmid DNA Production Process
Optimizing pDNA production in E. coli requires strategic media selection and scale-up planning. Explore a study that identifies ideal conditions for high-yield manufacturing.
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Analysis Of Partial Capsids Using Empty-Full Capsid Kit
Discover how to assess AAV genome integrity beyond ITR-2 using an extended ddPCR method for precise quantification of empty and full capsids with various genomic targets.
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A Journey To Produce MSC-Derived Cell Therapies From Isolation To Large-Scale
Drive successful MSC therapy development by optimizing isolation methods, surface chemistry, and closed-system expansion technologies to ensure cellular stability and commercial scalability.
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Advances In Analytical Method Selection And Technology Transfer
Successful analytical method transfer is crucial for product quality and regulatory compliance. Learn best practices for tech transfer, including how gap assessments mitigate common risks and streamline bioprocessing.
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Digitized Solutions To Increase Visibility And Streamline Communication Between A PSP And Manufacturer
When email-based escalation management creates compliance and visibility gaps, a centralized digital solution helps manufacturer and PSP teams act faster and with greater accountability.
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The Proven Supplement For CAR-T Solid Tumor Cytotoxicity
Optimize cell culture for solid tumor research. Replacing traditional serum can significantly enhance CAR-T cytotoxicity, improve consistency, and streamline the path to GMP-ready workflows.
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Evaluate The Effects Of A Xeno-Free Serum Replacement Media Supplementation
This study compares the impact of a specific Human Growth Factor Concentrate (hGFC) and fetal bovine serum (FBS) on the growth, expansion, and viability of MSCs.
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The Unique Challenges Of The Cell & Gene Therapy Supply Chain
Cell and gene therapies present unique logistical challenges for the supply chain, requiring careful consideration of factors like shelf life, packaging, temperature, and chain of custody.
NEWSLETTER ARCHIVE
- 04.06.26 -- New Podcast Episodes: Regenerative Skin Therapy, Orally Available Biologics, Regulatory Flexibility In CGT, and More
- 04.06.26 -- February 2026 — CDMO Opportunities And Threats Report
- 04.03.26 -- Zymeworks Shares Its Design Rationale (And Wins) In Early-Phase ADC Trials
- 04.02.26 -- Navigating GMP Biosafety Challenges In ATMP Manufacturing
- 04.01.26 -- The In Vivo Cell Therapy Shift On Display At PMWC 2026
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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