The missing link between data generation and unleashing it to power automation often lies in well-governed cloud infrastructure.
- 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
- Closing The MES Value Gap: Why Technology Isn't The Problem
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Epigenetics Application Guide
To fully understand biology and disease mechanisms, it is crucial to explore the role of epigenetic factors. Explore how epigenetic regulation works and methods to study these essential components.
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Rescuing A Global Program For NDA Success
Explore the collaboration that enabled FDA approval of a novel chronic-condition therapy, rescued a high-risk program, and demonstrated a unified “one-team” approach by reworking the sponsor's SAP.
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Manufacturing ADCs: Extractables In Single-Use Systems
Antibody-drug conjugates offer targeted cancer treatment with reduced toxicity. Discover how single-use technologies simplify ADC manufacturing to ensure safety, flexibility, and efficiency.
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Scale-Up Approaches For Culturing Adherent Cells
For successful scale-up, see how optimizing process parameters such as attachment methods, gassing, and agitation can help reduce cell environmental stress, ultimately improving productivity.
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Ensuring Supply Through Speed And Transparency
Through speed, transparency, and close collaboration, the pharmaceutical company was able to switch vendors seamlessly, maintaining virtually uninterrupted manufacturing operations.
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Expansion Of Human Bone Marrow-Derived MSCs
Achieving over 870 million viable, quality mesenchymal stem/stromal cells is possible. This efficient cell culture method scales bone marrow-derived MSCs for clinical needs.
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A Human-Relevant Model Of The Liver Sinusoid
This organ-on-a-chip model minimizes drug absorption while maintaining the essential architecture. Explore the specifications of this product engineered to model the human liver.
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Matrigel Dome Assay And Drug Screening Of Colorectal Cancer Organoids
Using 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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Tailoring Viral Clearance Study Design
Viral‑clearance studies need phase‑appropriate design, strong virus stocks, modality‑specific risk assessment, and alignment with evolving regulations for reliable safety outcomes.
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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.
NEWSLETTER ARCHIVE
- 05.22.26 -- Scaling RNA & LNP Manufacturing With Smarter Analytics
- 05.22.26 -- Inside March Biosciences' CD5-Targeting CAR-T Approach
- 05.21.26 -- Advancing Bioprocessing: Perfusion And Process Intensification Across Modalities
- 05.21.26 -- Regeneron Advances In Vivo Gene Therapy For Hearing Loss
- 05.20.26 -- Streamlined Lentiviral Characterization And QC With Digital PCR
- 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.
More Content Collections