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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Accelerating Clinical Data Review With Traceable Workflows
Clinical data review needs centralized access and traceable workflows. Leveraging AI-automation and real-time collaboration drives faster, better-informed decisions and reduced compliance risk.
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Quality By Design In The Pharmaceutical Industry
Real-time release and digital quality management, powered by PAT, are driving efficiency and compliance, reshaping how manufacturers achieve speed, consistency, and competitive advantage.
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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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Simplified Workflow Using Automated Instrument Setup And Compensation On The BD FACSLyric™ Flow Cytometer
Examine the usability and performance capabilities of a system that provides a streamlined flow cytometry workflow, from instrument initialization to data acquisition and analysis.
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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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Cell Culture Media Mixing In A Benchtop Single-Use Mixer
Explore how efficient powder-liquid mixing and sterile filtration preserve media integrity and support reproducibility in biopharmaceutical workflows, with promising scalability for larger-volume applications.
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Improving Methodologies For iPSC Manufacturing And Differentiation
Learn how next-generation workflows are being developed to streamline iPSC manufacturing, enhance differentiation strategies, and overcome the hurdles of scalability and consistency.
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Comparison Of Constant- And PulsedField Electrophoresis
Accurate sizing of large DNA fragments is crucial in long‑read sequencing. Examine how different electrophoresis methods perform with 10–20 kb smears and how to choose the most reliable approach.
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Impact Of Media Selection
To highlight the importance of media selection, a study was conducted assessing the effect of three commercially available cGMP grade medias and their influence on T-cell phenotype.
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Improving CD Media Titers With Nu-Tek Peptones
Adding 0.2% soy peptone to chemically defined media increases CHO IgG production by 30–60%. This animal-free supplementation enhances titers while maintaining high process control.
NEWSLETTER ARCHIVE
- 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
- 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
- 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