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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Simplifying Adenoviral Purification For Scalable Manufacturing
As vector design advances, downstream purification limits adenoviral manufacturing. A membrane-integrated hybrid train reduces product loss and process complexity at scale.
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Crude Peptide Purification Optimization For Scalable Manufacturing
Transitioning lentiviral vectors to final drug product raises quality demands. A simplified membrane-based capture step minimizes downstream losses that can constrain systemic dosing.
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The Value Of Peptones For Enhancing Biopharmaceutical Productivity
Peptones, versatile media additives derived from various sources, offer numerous benefits for biopharmaceutical production.
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Efficient Clone Screening With Increased Process Control And Integrated Cell Health And Titer Measurements With The Cydem VT Automated Clone Screening System
Automated screening of antibody-producing clones provides real-time cell health and titer data, helping developers identify top-performing candidates earlier and with confidence.
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End-To-End Clinical, Biometrics, And Regulatory Support In Neurology
Discover how an integrated NDA strategy aligned data, vendors, and regulatory execution to achieve an on-time submission and approval without major FDA queries.
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How To Effectively Manage Local Affiliate Pharmacovigilance Outsourcing
Managing PV across dozens of markets strains even experienced safety teams. Learn about a framework that helps you maintain compliance, reduce risk, and scale confidently into new markets.
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Product Recovery Study For Fill Finish Applications
Surge bags are essential to fill finish efficiency, but poor drainage can cause costly product loss. Learn how drainage testing helps identify high-performance bags that maximize recovery and reduce waste.
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Developing Consistent And Reproducible 3D Spheroid Models
Improve 3D spheroid consistency by optimizing cell selection, seeding density, and plate geometry. See how practical workflows and comparative data help reduce variability and establish reliability.
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Pharmacovigilance Is Not A Checkbox: Rethinking Safety Monitoring From Day One
Cell and gene therapies demand a pharmacovigilance approach built from the ground up, not adapted from frameworks designed for conventional drug products.
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Inside The Payer Perspective On Cell And Gene Therapy Coverage
Find out what 19 US payer organizations revealed about CGT coverage decisions, pre-approval engagement timelines, and the clinical evidence they need most to approve high-cost therapies.
NEWSLETTER ARCHIVE
- 10.08.26 -- Streamline Lead Selection & Optimization For Cell Therapy Development
- 10.08.26 -- Risk Managing Through The Void Of ATMP Visible Particle Guidance
- 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.
- 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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