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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![GettyImages-171144953-cryopreservation-freeze]( "Small Volume ATMP Cryo-Freezing Strategies")
Small Volume ATMP Cryo-Freezing StrategiesDiscover best practices for cryopreserving small-volume ATMPs, focusing on sterility, viability, and efficiency with advanced containers and packaging.
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![GettyImages-2217581928 manufacturing, production]( "Collaborative Variability Reduction In Cell Culture Media")
Collaborative Variability Reduction In Cell Culture MediaVariability reduction programs improve biomanufacturing by controlling raw‑material complexity, optimizing critical attributes, and boosting productivity through data‑driven partnerships.
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![GettyImages-576919878-analytics-computer-testing-research-data]( "Advancing An Integrated Biopharma Workflow Strategy")
Advancing An Integrated Biopharma Workflow StrategyGlobal research teams were generating critical data in disconnected systems, hindering collaboration. Explore how unified workflows and a shared data backbone strengthen efficiency.
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![agenic-ai-GettyImages-2195607659]( "Real-Time Clinical Data Insights Delivered By Automation And AI")
Real-Time Clinical Data Insights Delivered By Automation And AIAutomated data flows and human‑guided AI enable faster, more reliable oversight into clinical trials. Learn how real‑time insights and unified monitoring support quality, efficiency, and readiness.
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![GettyImages-1356993441 mRNA]( "mRNA Purification Using Anion Exchange Chromatography At Ambient Temperature")
mRNA Purification Using Anion Exchange Chromatography At Ambient TemperatureExplore how anion exchange chromatography with dual gradient elution enables efficient mRNA purification at ambient temperature.
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![Getty Images-823447656-vector-viral-lab-AAV-cell-development]( "Optimizing Virus Bank Manufacturing")
Optimizing Virus Bank ManufacturingGain insight into two cases where clients were enabled to overcome obstacles during virus bank manufacturing.
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![GettyImages-597971944-viral-vector-AAV-adeno-associated-virus]( "The Key To Viral Vector Success")
The Key To Viral Vector SuccessEstablishing a robust and scalable viral vector process requires a multidisciplinary approach that incorporates expertise in foundational science, analytics, and biomanufacturing.
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![GettyImages-1186871650 PCR]( "Analysis Of Partial Capsids Using Empty-Full Capsid Kit")
Analysis Of Partial Capsids Using Empty-Full Capsid KitDiscover 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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![GettyImages-1158419849 lab]( "Formulation Development For Therapeutic Oligonucleotides")
Formulation Development For Therapeutic OligonucleotidesDiscover how expert formulation and analytical support enable the development of stable, injectable oligonucleotide therapies across diverse delivery routes and molecule types.
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![GettyImages-1330728771-microscope-lab]( "Performance Of HEKima™ Adherent HEK Cell Medium")
Performance Of HEKima™ Adherent HEK Cell MediumExplore the performance of a serum-free medium designed for HEK-293 cells, comparing its efficacy to traditional media for protein expression and cell proliferation.
NEWSLETTER ARCHIVE
- 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
- 03.27.26 -- Accelerating Technology Diffusion In Cell And Gene Therapy
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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