Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.
- DEA Reveals Hidden Costs Of Analytical Validation Guidelines
- What LSPA's Life Sciences Future Says About The Road Ahead For CGT
- FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
- CDMO Selection Beyond Capabilities And Price
- August 2026 — CDMO Opportunities And Threats Report
- ICH M4Q(R2) And M16 Modernize The CTD For Digital Submissions
- Inside Scaling Next-Gen MSCs Without Scaling Risk
- Building Sustainable Biopharma Supply Chains Starts With Procurement
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Engineering Precision In Genetic MedicinesExplore how protein discovery, PAM engineering, and AI-guided optimization can expand target coverage, improve editing specificity, and address challenging therapeutic applications.
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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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![Home Diabetes Treatment iStock-1127801655]( "Bringing Clinical Trials To Everyone's Backyard")
Bringing Clinical Trials To Everyone's BackyardLearn 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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![HERMA - Form Fill Seal Applicator]( "Form Fill And Seal Label Applicator For Drug Packaging")
Form Fill And Seal Label Applicator For Drug PackagingDiscover a solution that ensures particularly efficient and reliable vertical and horizontal form fill and seal machine labeling.
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![ADC CDMO Selection for Small Biotech]( "ADC CDMO Selection For Small Biotech")
ADC CDMO Selection For Small BiotechManufacturing is a critical factor in ADC success. Discover how to align CDMO capabilities with molecule complexity, mitigate risks, and navigate capacity limits.
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![agenic-ai-GettyImages-2195607659]( "Real-Time Clinical Data Insights Delivered By Automation And AI")
Real-Time Clinical Data Insights Delivered By Automation And AIAutomated data flows and human‑guided AI enable faster, more reliable oversight into clinical trials. Learn how real‑time insights and unified monitoring support quality, efficiency, and readiness.
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![Improving Bioprocess Monitoring And Control With Multivariate Data Analysis]( "Improving Bioprocess Monitoring And Control With Multivariate Data Analysis")
Improving Bioprocess Monitoring And Control With Multivariate Data AnalysisLearn about multivariate data analysis (MVDA) techniques, like PCA and PLS, that enable near real-time monitoring, prediction, and optimization of biomanufacturing processes.
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![Lung disease treatment-GettyImages-1557382987]( "Accelerating A Global, FIH ADC Therapy Trial For Lung Cancer")
Accelerating A Global, FIH ADC Therapy Trial For Lung CancerChoose a development partner who can navigate global execution, ADC-specific challenges, and Project Optimus requirements so your first-in-human study is designed and positioned for success.
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![GettyImages-2193144544-scientist-cell-culture-in-lab]( "Exploring The Future Of Cell Expansion In Cell Therapy Manufacturing")
Exploring The Future Of Cell Expansion In Cell Therapy ManufacturingAs cell therapy scales, success depends on more than clinical promise. Smarter expansion strategies, automation, and flexible manufacturing platforms are becoming critical for improving consistency.
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![GettyImages-657049072 vaccine, pharma]( "Navigating The CGT Supply Chain: Key Logistical Challenges And Solutions")
Navigating The CGT Supply Chain: Key Logistical Challenges And SolutionsCommercializing cell and gene therapies requires overcoming complex logistical hurdles. Customized strategies for temperature control, compliance, and end-to-end delivery are crucial to prevent supply chain issues.
NEWSLETTER ARCHIVE
- 10.07.26 -- What's Driving The Next Wave Of Genome Editing?
- 10.07.26 -- New USP Guidelines, Standards Address Lentivirus Characterization
- 10.06.26 -- Structuring CGT Deals For The Long Term With Troutman Pepper Locke's EA Weeks, J.D., Ph.D.
- 10.06.26 -- Inside Scaling Next-Gen MSCs Without Scaling Risk
- 10.05.26 -- Enzyme Activity As A Surrogate Potency Marker In Cell Therapy
- What LSPA's Life Sciences Future Says About The Road Ahead For CGT
- 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
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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