AI is surfacing within regulatory and CMC workflows at a vigorous pace. Unfortunately, in small and midsize biotechs, it's happening faster than governance can keep up.
- Why FAT Should Confirm Alignment, Not Reveal Its Absence
- Managing Supply Disruptions In ATIMP Clinical Trials
- Why Cell And Gene Therapy Has Not Reached More Patients — And Why Clinical Operations Is The Bridge
- What Reliance, Annex 1, And AI Mean For The Future Of GMP
- Advancing Autologous Stem Cell Engineering For Diabetes And Vision Loss
- Applying Contamination Control By Design: A Practical Guide For CDMOs
- Field Notes: Freeing Process Data For Automation At Kivi Bio AI Summit
- CGT Manufacturing Shifts From Capacity To Strategy
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1462154865 Scientist Using Laptop In Manufacturing Facility]( "CDMO Accelerates Contract Manufacturing With Electronic Batch Records")
CDMO Accelerates Contract Manufacturing With Electronic Batch RecordsA prominent CDMO sought a specialized software solution to streamline and accelerate its manufacturing processes, enabling the efficient production of complex, customized products in record time.
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![mammlian-cell-lines-GettyImages-1690936576]( "Bridging Studies For Producer Cell Line Adoption: Regulatory And Development Perspectives")
Bridging Studies For Producer Cell Line Adoption: Regulatory And Development PerspectivesExplore how analytical comparability, risk assessment, and bridging strategies can support a smooth and compliant platform transition.
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![tablet for medicine management, stock research or inventory, Digital technology-GettyImages-1666055403]( "Reducing Inventory Errors In Clinical Trials")
Reducing Inventory Errors In Clinical TrialsCan 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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![SUS - homogenization]( "Study: Ensuring Homogeneity In Biopharmaceutical Aliquotation")
Study: Ensuring Homogeneity In Biopharmaceutical AliquotationTired of manual manipulation risks in biopharmaceuticals? Discover how automated homogenization ensures consistent cell counts and concentration levels, improving patient safety and process reproducibility.
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![Antibodies And Proteins GettyImages-1364886992]( "Innovating The mAb Characterization Process")
Innovating The mAb Characterization ProcessUnderstanding the characteristics of a molecule's "personality" is crucial for optimizing development and manufacturing. Learn how to overcome the challenges in the characterization process.
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![GettyImages-2181934436-laboratory-analysis-scientists-technology-computer]( "Streamline Analytical Tech Transfer Through Analytical Target Profile")
Streamline Analytical Tech Transfer Through Analytical Target ProfileAnalytics debt in CGT can derail timelines and budgets. Learn how early ATP planning and cross-functional alignment can eliminate costly setbacks and accelerate IND approvals.
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![GettyImages-1187680243-biological-indicator-sterilization]( "Efficient Late-Stage Development Of Biologics")
Efficient Late-Stage Development Of BiologicsReducing biologics manufacturing costs requires strategic late-stage process development, yield optimization, scale-up, and raw material substitution—all while maintaining product quality and regulatory compliance.
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![GettyImages-2163606903-gloves-pipet-cell-culture-assay]( "Rapid Selection Of High-Performance CHO Basal And Feed Media")
Rapid Selection Of High-Performance CHO Basal And Feed MediaA CHO-S bispecific antibody program needed a better basal and feed media combination. Learn how the screening of 180 conditions in 12 weeks identified one that delivered 38% higher titers.
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![GettyImages-547131922 research, regulatory, lab]( "What FDA CRLs Reveal About Method Validation")
What FDA CRLs Reveal About Method ValidationFDA rejection letters reveal validation failures are structural, not technical. Weak lifecycle oversight, robustness, and documentation continue to delay approvals despite clear guidance.
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![GettyImages-1409578453-mRNA-LNP-lipid-nanoparticle-RNA therapy]( "TFF Cassettes With 100 kDa Membranes For RNA And LNP Applications")
TFF Cassettes With 100 kDa Membranes For RNA And LNP ApplicationsThis study showcases the performance of regenerated cellulose flat sheet membranes with a 100 kDa molecular weight cutoff for UF/DF of RNA molecules by TFF.
NEWSLETTER ARCHIVE
- 06.04.26 -- Next-Gen Precision Control For Cell Therapy Workflows
- 06.04.26 -- Distributed Manufacturing For CGT: Rent, Lease, Or Buy In An Era Of Overcapacity?
- 06.03.26 -- From Gene to GMP: Solving Advanced Therapy's Toughest Manufacturing Challenges
- 06.03.26 -- Will FDA's One-Day Inspection Pilot Stand The Test Of Time?
- 06.02.26 -- STREAM Edition: Redefining CAR-T Timing And Patient Access With Allogene Therapeutics' Dr. Zachary Roberts
- 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
- Sana, Mayo Clinic Advance A New Model For Cell Therapy Delivery In T1D
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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