Learn what regulators are already asking about AI, what quality must mean in this new context, and how organizations can begin building the governance infrastructure.
- The Systems And Choreography Needed For Grade B ATMP Material Transfer
- Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign
- Navigating GMP Biosafety Challenges In ATMP Manufacturing
- Ensuring Quality Of CGT Materials
- 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
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Biopharma Supply, Reimagined: Regional, Resilient Manufacturing
Persistent disruption is redefining biopharma supply chains. Explore how regional manufacturing, integrated risk management, and closer collaboration help build resilience and improve agility.
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Maximizing Scale-Up Efficiency Of A mAb Upstream Process
This study demonstrated the effectiveness of a medium and feed system when tested at three different scales for its ability to high-quality, fed-batch monoclonal antibodies.
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ICH E6(R3) In Effect: Transforming Quality Management For CGT Trials
Discover how the updated ICH E6(R3) guideline supports the speed and complexity of CGT manufacturing, enabling flexible, risk‑based decisions and quality systems built to scale therapies safely.
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Manufacturing IPC/QC Of Gene-Engineered HSCs
In-process and quality control ensure consistent manufacturing of gene-engineered hematopoietic stem cells. Discover an engineering process that enhances production through viral transduction and integrated sampling pouches.
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Cell Retention Technology And Specialized Cell Culture Media
Explore how perfusion technology is transforming upstream bioprocessing by boosting productivity, reducing costs, and enabling process intensification while overcoming cell retention challenges.
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Perfusion Cell Line Development For Intensified Processes
The biopharmaceutical industry is transforming by shifting to continuous and intensified upstream bioprocesses, which are driven by evolving demands. Discover the key goals and innovations shaping this transition for modern healthcare.
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How Can You Avoid Bioprocessing Risks When Using Cable Ties?
Cable ties in bioprocessing can cause leaks, damage, and delays. See how switching to a uniform-sealing connector can significantly improve efficiency, reduce prep time, and minimize contamination risks.
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How To Unlock The Secret To Repeatable, Scalable Low Turnover
Here, we explore the evolution of a 10-year partnership and extrapolate the principles that create cohesive teams and minimize turnover.
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Transforming Development Through Mass Spectrometry Data Analysis
Mass spectrometry is vital for understanding PTMs in modern biologics. Explore key challenges and how streamlined analysis can reveal deeper, more sensitive insights into biotherapeutic structure.
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A Scalable Manufacturing Platform For The Purification Of Stem Cell Derived Exosomes
EV production scale increases require paired robust, scalable, and cost-effective downstream processes. Process parameters can be tailored for therapeutic exosome programs and allow for maximum exosome recovery.
NEWSLETTER ARCHIVE
- 04.07.26 -- STREAM Edition: Regulatory Flexibility In CGT: Key Shifts And Implications With Monika Swietlicka
- 04.07.26 -- Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign
- 04.06.26 -- New Podcast Episodes: Regenerative Skin Therapy, Orally Available Biologics, Regulatory Flexibility In CGT, and More
- 04.06.26 -- February 2026 — CDMO Opportunities And Threats Report
- 04.03.26 -- Zymeworks Shares Its Design Rationale (And Wins) In Early-Phase ADC Trials
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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