Here's a holistic approach to developing a comprehensive particulate control strategy for cell therapies, focusing on particle characterization, detection, and manufacturing controls.
- 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
- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 2: Objective Measurement Tools
- How CGT Developers Should Think About Manufacturing Models, Hybrid Strategies, And Scale
- Enhancing Gene And Cell Therapies With Circular RNA-Based Gene Expression
- FDA Explains How To Respond To Form 483 Observations In New Draft Guidance
- Organizing Digital Systems Around Novel Modalities
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Enhancing Novel Developability Through Automated MS Analytics
Growing biotherapeutic complexity demands MS workflows that can unify diverse datasets. Learn how automated approaches enhance data quality, streamline analysis, and support faster development.
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Automated Library Prep For Nanopore Human Whole Genome Sequencing
Gain insight into an automated high‑input workflow that streamlines long‑read whole‑genome library prep, supporting large DNA fragments while reducing reagent use.
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Partner Case Study: Accelerating Gene Editing Manufacturing
Beam Therapeutics partnered with ElevateBio to manufacture BEAM-101, a novel base editing therapy for sickle cell disease, advancing rapid, high-quality production towards clinical trials.
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Maintain Sterility And Ease In CGT Development, Including Cryopreservation
Sterile connectors streamline cell and gene therapy processes while maintaining sterility. By withstanding extreme temperatures and cryoprotectants, they can ensure product viability during cryopreservation.
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Ultra-Low Cross-Linked Microgel Purification
ULC microgel purification is often slowed by linear polymer contamination and limitations of centrifugation. Explore how hollow fiber TFF improves filtration efficiency and supports scalable processing.
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Automation Of 3D Intestinal Organoids Culture
Gain insight into how 3D organoids promise better disease modeling and drug screening and how challenges like assay complexity, reproducibility, and scalability hinder their widespread adoption in drug discovery.
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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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ADC Development Grows More Complex — SPR Insights Bring Clarity
Explore how real-time kinetic analysis reveals how conjugation, linker chemistry, and drug loading influence antibody–antigen interactions, while enabling sensitive detection of anti-drug antibodies.
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Reducing Inventory Errors In Clinical Trials
Can a digital double-check save your trial from data errors? How does verifying shipments at receipt slash inventory mistakes? Learn to protect protocol integrity and patient safety.
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Redefining Biomanufacturing For Personalized Cancer Vaccines
Personalized cancer vaccines need fast, flexible manufacturing. Cell‑free synthetic DNA enables rapid, small‑batch mRNA production, supporting individualized therapies beyond plasmid‑based limits.
NEWSLETTER ARCHIVE
- 07.11.26 -- Cell & Gene Newsletter - Best Of June
- 07.10.26 -- Managing Supply Disruptions In ATIMP Clinical Trials
- 07.09.26 -- From Clone To Commercial: Redefining Cell Therapy Workflows
- 07.09.26 -- Applying Contamination Control By Design: A Practical Guide For CDMOs
- 07.08.26 -- Why In Vivo Therapies Are Moving Toward the Clinic with Ascidian Therapeutics' Dr. Mike Ehlers
- 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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