Cell therapy products challenge traditional particulate controls. One expert explains detection, mitigation, and contamination prevention.
- Reassessing Nanoparticle Immunotoxicity: From Well-Established To Novel Approaches
- Building CGT Manufacturing Capacity For The Next Commercial Era
- Managing The Presence Of Visible Particulates In Cell Therapies
- FDA Approval Of TREGZI Signals A New Era For Precision Engineered Cell Therapy
- Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis
- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program
- Wondering If Your Org Should Purchase R&D Datasets?
- Mapping Early-Phase Supply Chain Bottlenecks That Doom Pipelines
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Building A Scalable Global T Cell Manufacturing Platform
Achieve scalable T cell manufacturing with automation, standardized workflows, and integrated quality control to enable high-yield production, flexible scheduling, and seamless tech transfer.
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Regulatory Considerations For Excipients Used In Lipid Nanoparticles
Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.
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Life Cycle Assessment Of Extended Use Strategies For Single-Use Assemblies
Examine how extending the use of single‑use assemblies can significantly reduce emissions, resource consumption, and waste in bioprocessing, offering a data‑backed path toward sustainability.
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Bridging Studies For Producer Cell Line Adoption: Regulatory And Development Perspectives
Explore how analytical comparability, risk assessment, and bridging strategies can support a smooth and compliant platform transition.
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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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Bringing Clinical Trials To Everyone's Backyard
Learn how bringing clinical trials to any community around the world is not only possible but also increases patient access and reach and improves recruitment and retention.
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Activate Advanced Contamination Control Technology To Safeguard Your Cell Therapy
The most common contamination risks in cell therapy manufacturing are open processes that leverage different products, inflexible instruments, labor intensive workflows, lack of in-line monitoring, and zero failure tolerance.
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The Proven, Practical Gateway To Upstream Process Intensification
N-1 perfusion enables higher inoculum densities, faster production, and reduced costs without altering fed-batch processes. Explore a practical path to intensification for biologics manufacturers.
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Advancing An Integrated Biopharma Workflow Strategy
Global 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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High-Throughput 90-Minute ELISA
Discover how one solution can be utilized to measure Human IgG and human IFN gamma, which are key targets in pharmacokinetic studies and immunotherapeutic drug safety testing, in just 90 minutes.
NEWSLETTER ARCHIVE
- 07.15.26 -- Human-Centric Models For Modern Drug Development
- 07.15.26 -- FDA's Guidance On Cell And Gene CMC Codifies Flexibility
- 07.14.26 -- STREAM Edition: The Facility Master Planning Playbook With Herman Bozenhardt
- 07.14.26 -- Advancing Autologous Stem Cell Engineering For Diabetes And Vision Loss
- 07.13.26 -- Practical Strategies for Contamination Control and EM Compliance
- FDA Approval Of TREGZI Signals A New Era For Precision Engineered Cell Therapy
- How CGT Developers Should Think About Manufacturing Models, Hybrid Strategies, And Scale
- In Vivo Gene Editing Is Moving From Promise To Proof
- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
- CGT Manufacturing Shifts From Capacity To Strategy
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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