Here's why scaling MSC therapies requires maintaining product consistency, potency, and comparability as manufacturing evolves.
- In Case You Missed Them: Recapping The FDA's Recent Guidances For Cell And Gene Therapies
- Why You Should Measure Comparability Debt Before Ever Starting A Study
- What FDA Inspectors Want From Your OOS File
- You Can't CAPA What You Can't Classify
- New USP Guidelines, Standards Address Lentivirus Characterization
- Inside Kyverna's Autoimmune CAR T Platform Beyond SPS
- Bringing Next-Gen Sequencing To GMP Scale
- Risk Managing Through The Void Of ATMP Visible Particle Guidance
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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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Get Reproducible Purification Scale-Up Results Faster
Is it difficult to reproduce laboratory purification results at process scale? We evaluated three prepacked columns from 1.6 to 33 cm column inner diameter (ID) with 20 cm bed height to observe their purification profiles.
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Automated Sampling Of A Four Vessel Parallel CHO Cell Culture
Learn how automated sampling for parallel bioreactors enables continuous, sterile sample collection from CHO cell cultures, maintaining cell density with reduced manual intervention.
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Prevent The Risk Of Cross-Contamination With Microbial Colony Pickers
Explore a microbial colony picker that streamlines lab workflows to ensure rapid and accurate genetic library screening. Key features include UV sanitization, pin washing, and halogen drying, which meets GMP standards.
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Integrating Cutting-Edge Technologies In Cell Bank Manufacturing
Discover how our adoption of a counterflow centrifuge enhances GMP-compliant cell banking through closed-system automation, precision harvesting, and scalable workflows.
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De-Risking The Neurology IND: Lessons From Early FDA Engagement
Learn how early FDA alignment can help your neurology program move forward with greater clarity, confidence, and regulatory readiness.
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Automated T Cell Manufacturing From Start To Fill
Gain insight into how an automated, closed workflow can integrate T cell enrichment, activation, transduction, expansion, and formulation across fresh and frozen starting materials.
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Unlocking Recruitment Potential In Trial-Naïve Sites
Site Professional Support enabled this late-phase rheumatoid arthritis study to conduct complex patient visits despite its use of sites that lacked research experience and resources.
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Evaluating Antibody Fragment Purification Using VH3 Resin
Explore how VH-domain targeting enables efficient purification of VH3 antibody fragments and bispecific formats, with strong recoveries and flexible wash conditions that support improved purity.
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A Beginner's Guide To Sf9 Culture In Stirred-Tank Bioreactors
Learn about the workflow steps for Sf9 cell expansion, virus preparation, and protein production in stirred-tank bioreactors, including GFP expression.
NEWSLETTER ARCHIVE
- 09.25.26 -- The Promise Of MRD-Guided CAR-T Treatment
- 09.24.26 -- OPCU Special CPHI Session: Trends Shaping Advanced Therapies
- 09.24.26 -- The Unspoken Truth About Cell Therapy Product Understanding
- 09.23.26 -- Europe's ATMP Opportunity Still Requires Local Navigation
- 09.22.26 -- How Regeneron Navigates Early Cell And Gene Therapy Quality Risks
- Inside Scaling Next-Gen MSCs Without Scaling Risk
- Inside Kyverna's Autoimmune CAR T Platform Beyond SPS
- Autoimmune CAR T Has Hit A Critical Moment. Are We Asking The Right Questions?
- Why Celcuity's REVTORPYK Creates A New Path For Precision Oncology
- In Vivo CAR T Needs More Than Better Cell Engineering
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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