The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.
- Zymeworks Shares Its Design Rationale (And Wins) In Early-Phase ADC Trials
- Ever Wonder What Running A $50B Capital Facilities Project Feels Like?
- Generative AI Can Write The Code, But Who Builds In The Quality?
- From "Live Drug" To Precision Tool: Redefining CAR T Safety
- UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk
- February 2026 — CDMO Opportunities And Threats Report
- COGs And Biology, Two Endpoints Needlessly At Odds In Advanced Therapy
- The Long Road To U.S. Vaccine Manufacturing
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Industry-Leading Advanced Therapy Support Revolutionizing Transport
Learn about a validated dry ice shipping system that fills a critical gap in the life sciences industry and is revolutionizing the transport of high-value commodities such as advanced therapies.
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Scalability And Reproducibility Of The AAV9 Capture Step
Scaling gene therapies beyond rare diseases demands innovation. Discover a chromatography system that boosts efficiency, protects product integrity, and overcomes viral vector manufacturing challenges.
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Customer Story: Emergent BioSolutions Enhances Aseptic Filling Process
Upgrading outdated filling systems is essential for meeting future production demands and regulatory standards. Learn how one manufacturer modernized its approach to ensure compliance and efficiency.
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Next Generation Sequencing In Viral Safety Testing
Next Generation Sequencing (NGS) offers a sensitive, high-throughput solution for detecting adventitious viral agents (AVAs), improving biopharmaceutical safety and accelerating regulatory-compliant product development.
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Accelerate LNP Manufacturing With Automated Process Development
Manual LNP formulation introduces process variability that threatens particle quality and yield. As programs scale toward clinical production, maintaining strict control over CQAs becomes essential.
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Automating Mass Spectrometry Analysis To Accelerate Oligonucleotide Drug Development
Oligonucleotide therapeutics demand precise and efficient analytical workflows. Explore how automated data processing offers a faster path to understanding metabolites and advancing development.
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Unlock The Power Of Clinical Data Science
Discover a unified, AI‑driven approach that helps clinical teams manage growing data complexity, accelerate insight generation, and improve trial oversight to enable faster decisions.
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Controlled Production Of MSC-Derived EVs In Stirred-Tank Bioreactors
Learn how stirred-tank bioreactors overcome the scalability limitations of static culture for MSC-EV production, while Raman spectroscopy provides unprecedented real-time quality monitoring during production.
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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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Contamination In The Shadows: Risks Lurking From Environmental Issues
Discover how science-based bio-decontamination strategies effectively eliminate invisible pathogens and rapidly restore facilities to operational safety following major infrastructure disruptions.
NEWSLETTER ARCHIVE
- 03.27.26 -- Accelerating Technology Diffusion In Cell And Gene Therapy
- 03.26.26 -- The Hidden Obstacles Stalling Advanced Therapies
- 03.26.26 -- FDA's 483 Playbook: What It Means And Misses For Pharma Outsourcing
- 03.25.26 -- A simple, helpful look at PUPSIT implementation.
- 03.25.26 -- Building Harmonized Real‑World Data In 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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