This article addresses the three contamination control challenges that are specific to the CDMO environment, provides five practical steps any organization can act on now, and more.
- Rethinking CQV In A Digital, Agile Manufacturing Landscape
- Will FDA's One-Day Inspection Pilot Stand The Test Of Time?
- The Next Frontier In Women's Cancer Care: Combining Cell Therapy With Immuno-Oncology
- Spine Care Redefined: Autologous Cell Therapy For Degenerative Disc Disease
- A Multi-Agent Audit Intelligence Framework For CDMO Quality Oversight
- Why Contamination Control By Design Should Matter To Your CDMO
- Repeating Sanofi's Ballroom Design On Two Continents
- Early CDMO Engagement For Cell Therapies? CellProthera's CEO Thinks Not
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1213680755-scientist-gloves-assay-cell-culture]( "Speeding Up Safety: An Evaluation Of Mycoplasma Technology")
Speeding Up Safety: An Evaluation Of Mycoplasma TechnologyRapid mycoplasma testing enhances cell and gene therapy safety by reducing turnaround time, minimizing sample needs, and delivering sensitive, reliable contamination detection across diverse matrices.
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![GettyImages-1441343945-virus-viral-infection]( "Enhanced Development Of Virus-Specific Hybridomas")
Enhanced Development Of Virus-Specific HybridomasDouble-stranded DNA viruses cause various human diseases, which complicates diagnosis due to antigen conservation. Explore a cell line that produces specific monoclonal antibodies to aid biotherapeutics development.
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![GettyImages-1091167386-virus-cell]( "Virus Reduction And Impurity Removal")
Virus Reduction And Impurity RemovalExamine a DOE-based study that reveals how buffer conditions impact virus and impurity clearance using a mixed-mode resin, as well as gain practical guidance for optimizing downstream purification.
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![GettyImages-1337678825-assay-well-plate-cell-culture]( "Matrigel Dome Assay And Drug Screening Of Colorectal Cancer Organoids")
Matrigel Dome Assay And Drug Screening Of Colorectal Cancer OrganoidsUsing CRC organoids and bioprinting, explore the automation of dome assays to evaluate drug responses and delve into the insights from image-based end-point assays on the efficacy of anti-cancer treatments.
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![GettyImages-1323467662 data, meeting, strategy]( "Don't Let Distribution Derail Your CGT Launch")
Don't Let Distribution Derail Your CGT LaunchOvercoming distribution challenges is critical for the success of cell and gene therapies. Learn how to build a flexible, robust strategy to optimize patient access.
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![GettyImages-1309776504-viral-inspection-laboratory-scientists]( "Next Generation Sequencing In Viral Safety Testing")
Next Generation Sequencing In Viral Safety TestingNext Generation Sequencing (NGS) offers a sensitive, high-throughput solution for detecting adventitious viral agents (AVAs), improving biopharmaceutical safety and accelerating regulatory-compliant product development.
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![Viral Safety In Monoclonal Antibody Manufacturing-Getty-184714532]( "Study Viral Infection In Resting Humans CD4+ T Cells With Synthetic sgRNAs")
Study Viral Infection In Resting Humans CD4+ T Cells With Synthetic sgRNAsDiscover how Synthego's proprietary synthetic sgRNA, combined with Lonza’s 4D-Nucleofector®, enabled highly efficient gene editing in resting human CD4+ T cells.
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![GettyImages-2181934436-laboratory-analysis-scientists-technology-computer]( "Streamline Analytical Tech Transfer Through Analytical Target Profile")
Streamline Analytical Tech Transfer Through Analytical Target ProfileAnalytics debt in CGT can derail timelines and budgets. Learn how early ATP planning and cross-functional alignment can eliminate costly setbacks and accelerate IND approvals.
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![GettyImages-1388184871-quality-compliance-approval]( "Immuno-Oncology Biomarker Measurement With High Sensitivity And Speed")
Immuno-Oncology Biomarker Measurement With High Sensitivity And SpeedExplore results demonstrating the successful use of innovative ELISA assays to detect three key biomarkers: Programmed Death Ligand 1 (PD-L1), Interleukin-8 (IL-8), and Interferon Gamma (IFN-γ).
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![GettyImages-1405590436-lab-perfusion-cleanroom]( "Laminar And Turbulent Mixing Techniques For LNP Formulations Scale Up")
Laminar And Turbulent Mixing Techniques For LNP Formulations Scale UpExplore the critical factors in scaling up lipid nanoparticle (LNP) formulation, comparing the advantages and limitations of both laminar (microfluidic) and turbulent (tee and jet) mixing technologies.
NEWSLETTER ARCHIVE
- 05.27.26 -- Smarter Processing For Workflows From Discovery To Commercial Scale
- 05.27.26 -- Rethinking Sterile Welding In Bioprocessing
- 05.27.26 -- Bridging Analytical Gaps To Ensure CGT Material Quality
- 05.26.26 -- Why Material Definitions Matter In Cell And Gene Therapy
- 05.26.26 -- Spine Care Redefined: Autologous Cell Therapy For Degenerative Disc Disease
- 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
- Reprogramming T-Cell Access To Solid Tumors Through Improved Trafficking And Entry
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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