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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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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Adapting Single-Use Chromatography To Manufacturing Scale
Explore strategies for accommodating the ever-increasing upstream titers and volumes to prevent downstream purification from becoming a bottleneck.
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EMA Support For Rare Disease Therapies
Review how the EMA supports rare disease drug development through regulatory and financial incentives for therapies that meet strict eligibility and ongoing compliance criteria.
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How To Take Your Process To A Closed System
Understand the critical considerations for implementing closed systems in bioproduction, from vessel selection to workflow customization for optimal efficiency and safety.
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Ensuring cGMP Compliance In Cell And Gene Therapy Manufacturing
Discover how adhering to strict GMP guidelines and advanced equipment design ensures that complex, sterile cell and gene therapies are safely and effectively delivered.
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ATMP Cryopreservation Done Right - Best Practice In Small Volume Cryo-Freezing
Explore best practices for cryopreserving small-volume advanced therapy medicinal products (ATMPs), emphasizing sterility, cell viability, and efficiency using innovative single-use systems and aseptic connectors.
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Human Platelet Lysate (hPL) Improves Expansion Of MSCs
Learn how human platelet lysate significantly improves mesenchymal stromal/stem cell expansion and eliminates the need for plate coating, boosting yield without altering cell phenotype.
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Evaluating CAR T-Cell Therapy Vascular Recruitment, Trafficking, And Killing
Learn about a more human-relevant platform that enables researchers to assess the trafficking and killing efficiency of immunotherapy as well as the proof-of-concept of immuno-oncology co-therapy.
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Improved T Cell Expansion Using Closed, Automated Stirred-Tank Bioreactors
A shift from traditional rocking motion systems to stirred-tank bioreactors can enhance T cell expansion, offering greater scalability and more intimate process control.
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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