The final guidance articulates common practices around validation, stability data, and reserve samples that, up until now, had been applied on a case-by-case basis.
- Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation
- A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis
- Inside AstraZeneca's Fully Electrified Cell Therapy Facility
- AI Has Arrived In Biotech CMC Amid Patchwork Governance
- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
- CDMO Selection: Start With The Relationship, Not The RFP
- Why FAT Should Confirm Alignment, Not Reveal Its Absence
- Managing Supply Disruptions In ATIMP Clinical Trials
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-2192786673 antibodies]( "Integrated Upstream And Downstream Strategies For Robust Manufacturing")
Integrated Upstream And Downstream Strategies For Robust ManufacturingProcess robust mAb production requires understanding scale dependent cell environments, leveraging predictive models, and pursuing data driven control to minimize variability and optimize quality.
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![GettyImages-1480558197 Business Corporate Team Meeting]( "Enabling Market Access As CGTs Reach More Patients")
Enabling Market Access As CGTs Reach More PatientsBringing potentially curative cell and gene therapies to more patients requires a focused approach to market access. Discover essential insights into payer dynamics, pricing innovations, and treatment evolution.
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![GettyImages-1871216402-anaerobic-cultivation-of-probiotics]( "Anaerobic Cultivation Processes Of Probiotic Bacteria")
Anaerobic Cultivation Processes Of Probiotic BacteriaCultivate oxygen-sensitive probiotics with precision using real-time monitoring, microfluidic feeding, and pH control for reproducible growth and optimized microbiome and fermentation research.
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![GettyImages-2184219690-chimeric-antibody-3d-render]( "How To Design And Evaluate Bispecific Antibodies (BsAbs)?")
How To Design And Evaluate Bispecific Antibodies (BsAbs)?Bispecific antibodies combine two antigen-binding sites to enhance efficacy and safety. Their design requires structural strategy, MOA-based evaluation, and rigorous screening for optimal therapeutic performance.
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![GettyImages-545581230-lab-research-computer-tablet-teamwork]( "Demonstration Of Scalability For A Novel Fixed Bed Reactor Platform")
Demonstration Of Scalability For A Novel Fixed Bed Reactor PlatformDesigned to enable efficient scalability, a new FBR platform allows operators to use one technology, with a standardized workflow, for their process development, scale-up, and manufacturing processes.
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![GettyImages-1462147534 manufacturing]( "5 Steps To Design A Microbiological Performance Qualification For Facilities")
5 Steps To Design A Microbiological Performance Qualification For FacilitiesExplore five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.
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![GettyImages-1457289257 patient]( "Quantitative ROI With DCTs")
Quantitative ROI With DCTsThrough dedicated staffing, operational oversight, and collaboration with site teams, see how we were able to transform a struggling cardiology study into a revitalized recruitment effort.
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![CPC - aseptic processing]( "The Case For Modernizing Small-Volume Aseptic Processing")
The Case For Modernizing Small-Volume Aseptic ProcessingTube welding and biosafety cabinets present significant costs and risks for small-volume aseptic processing. Modern single-use aseptic connectors offer a more efficient alternative.
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![Lung disease treatment-GettyImages-1557382987]( "Accelerating A Global, FIH ADC Therapy Trial For Lung Cancer")
Accelerating A Global, FIH ADC Therapy Trial For Lung CancerChoose a development partner who can navigate global execution, ADC-specific challenges, and Project Optimus requirements so your first-in-human study is designed and positioned for success.
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![Scientist Using Tablet In Lab GettyImages-1354172577]( "384-Well Microplate Time Resolved Fluorescence (TRF) Immunoassay")
384-Well Microplate Time Resolved Fluorescence (TRF) ImmunoassayExamine how innovative sandwich ELISAs in a 384-well format can be utilized with a sensitive reader for high-throughput screening to quantify Human IgG and IFN gamma.
NEWSLETTER ARCHIVE
- 06.11.26 -- Translating Discovery Into Clinical Success
- 06.11.26 -- Bridging Innovation And Manufacturing In Cell & Gene Therapy
- 06.11.26 -- Why Contamination Control By Design Should Matter To Your CDMO
- 06.10.26 -- Control Contamination In Material Transfer Process
- 06.10.26 -- Bioprocess Innovation In Action: Insights, Expertise, And New Solutions
- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
- CGT Manufacturing Shifts From Capacity To Strategy
- Dr. Peter Marks On Why Gene Therapy May Need A New Regulatory Playbook
- Regeneron Advances In Vivo Gene Therapy For Hearing Loss
- Sana, Mayo Clinic Advance A New Model For Cell Therapy Delivery In T1D
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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