The FDA’s focus has shifted from tracking quality metrics to promoting quality management maturity. AI/ML is poised to help with efforts, though it introduces additional complexity around data integrity.
- 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
- UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk
- February 2026 — CDMO Opportunities And Threats Report
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Enhancing Preclinical Cell Therapy Development
Automation in cell therapy development boosts reproducibility, reduces error, and enhances yield. Learn how it’s reshaping preclinical workflows and accelerating clinical trial readiness.
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Spotlight On India: Regulatory Enhancements, Modernization, And Robust Data Collection
Explore India's adoption of global best practices, 24/7 work cycles, and audit readiness to ensure high standards of Good Clinical Practice, attract more trials, and provide robust data to stakeholders.
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Monitoring Bioprocesses In A Light Environment Using Raman Spectroscopy
Discover an advanced solution to facilitate the implementation of Raman technology at both laboratory and manufacturing scales in a normal light environment.
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Automated Library Prep For A Nanopore DNA Barcoding Protocol
A streamlined workflow reduces reagent use and hands‑on time while preserving long‑read sequencing quality. See how multiplexed offer an efficient option for scaling or mobilizing sequencing efforts.
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Co-Precipitation Of Metal Carbonate Templated Protein Microparticles
Explore the automated production of protein microparticles using an innovative method that offers a standardized and scalable solution for co-precipitation in biopolymer particle fabrication.
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The Proven, Practical Gateway To Upstream Process Intensification
N-1 perfusion enables higher inoculum densities, faster production, and reduced costs without altering fed-batch processes. Explore a practical path to intensification for biologics manufacturers.
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AAV Viral Titering Using Nanoplate-Based Digital PCR
Examine how nanoplate-based digital PCR streamlines AAV titering, providing faster results and greater accuracy, advancing gene therapy development from the lab to the clinic.
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Ready To Demystify Organoids?
Organoids are transforming biomedical research. Explore their top applications, research workflows, key challenges, and dissociation techniques in this comprehensive guide to personalized medicine.
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Jaw Crimping vs. Rotary Crimping: Enhancing Aseptic Assurance
Beyond a simple mechanical step, crimping is a critical control point. We examine how advanced rotary technology provides superior seal quality, particulate control, and data-driven compliance assurance.
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Measure And Control In-Line Protein Concentration
Streamline protein and antibody purification with an automated TFF system featuring real-time, in-line concentration measurement for enhanced accuracy, reliability, and cGMP compliance.
NEWSLETTER ARCHIVE
- 04.02.26 -- Navigating GMP Biosafety Challenges In ATMP Manufacturing
- 04.01.26 -- The In Vivo Cell Therapy Shift On Display At PMWC 2026
- 03.31.26 -- STREAM Edition: Take The Lead With A GS Cell Line Development Kit
- 03.31.26 -- UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk
- 03.30.26 -- The Long Road To U.S. Vaccine Manufacturing
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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