Cell therapies represent an important advancement in our ability to treat difficult cancers, but continued exploration of this new modality will require new digital tools and equipment.
- PUPSIT In Cell & Gene Therapy: Risk Reduction Or Operational Complexity?
- Is Your AI Model Trustworthy And Credible In GMP Processes?
- May 2026 — CDMO Opportunities And Threats Report
- In Vivo Gene Editing Is Moving From Promise To Proof
- Why Improving Drug Delivery Remains A Major Opportunity In Oncology
- FDA's Guidance On Cell And Gene CMC Codifies Flexibility
- Strategic Synthesis Of ASGCT And ASCO 2026
- Emerging Technologies In Aseptic Processing: Hype Vs. Operational Reality
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Suitability Testing For IVT mRNA Analysis
Automated capillary electrophoresis provides robust, precise analysis of IVT mRNA integrity, concentration, and size, demonstrating excellent method precision.
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CAR T Cell Generation From Cryopreserved Leukapheresis Products
A seven‑day CAR T cell manufacturing workflow shows how cryopreserved leukapheresis material can deliver high viability and strong antitumor activity, offering a more flexible path for production.
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Tailored Approach Supports Bladder Cancer Breakthrough
Discover how a flexible operational strategy and expert site management help bladder cancer programs overcome complex logistical hurdles and achieve critical regulatory milestones.
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Synthetic DNA As An Alternative For Scalable Viral Vector Production
Enzymatically synthesized DNA is assessed as a plasmid alternative, showing comparable viral vector yield, quality, and purification, while improving scalability and regulatory flexibility.
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Demonstrating Bioprocess Scalability Through Platform Consistency
Explore how a unified bioreactor design enables consistent process performance from bench to production, minimizing scale-up risk while maintaining cell growth and yield.
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Parallel Line Analysis And Relative Potency
Explore parallelism testing methods, including response and parameter comparison tests, with innovative software to ensure accurate results with detailed protocols for linear and non-linear regression curves.
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Essential Strategies For Effective Viral Clearance Studies In Biologics Manufacturing
Strengthen your viral safety strategy by applying science- and risk-based approaches to viral clearance planning, ensuring robust data, regulatory compliance, and patient protection.
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Analytical Approach For Bispecific Antibody Quality Study
Bispecific antibody quality control demands advanced analytics to detect mispaired species, assess structural integrity, and confirm potency, ensuring safety and efficacy across diverse therapeutic applications.
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Assessment Of Compound Toxicity Effects With High-Content Imaging
3D cellular models and bioprinting enhance drug safety predictions and offer precise spatial control. Explore an automated method for generating liver models to improve reproducibility and reliability in toxicity testing.
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Solutions For CQA Analysis Of IVT mRNA-Based Biotherapeutics
Discover new innovative solutions for mRNA analysis, enhancing accuracy and efficiency in IVT mRNA workflows, including advanced technologies and methodologies to optimize your research and development processes.
NEWSLETTER ARCHIVE
- 06.25.26 -- Better Biopharma's Editors' Roundtable — A Midyear Look At The 2026 Life Sciences Industry
- 06.24.26 -- Smarter risk management for single-use and filtration systems.
- 06.24.26 -- What's Driving Cell & Gene Therapy Forward? Key Trends & Insights
- 06.24.26 -- Advancing CAR T For Drug-Free Remission In Autoimmune Disease With Kyverna Therapeutics' Dr. Naji Gehchan
- 06.23.26 -- STREAM Edition: Why In Vivo Therapies Are Moving Toward The Clinic With Ascidian Therapeutics' Dr. Mike Ehlers
- 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
- Dr. Peter Marks On Why Gene Therapy May Need A New Regulatory Playbook
- Regeneron Advances In Vivo Gene Therapy For Hearing Loss
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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