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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Mycoplasma Testing In Monoclonal Antibody Production
Prevent costly disruptions in your bioproduction process. Discover how a PCR-based method can quickly detect the presence of mycoplasmas in raw materials, cell banks, and in-process and lot-release samples.
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Simpler, Faster, Cheaper Advanced Therapy Manufacturing
Discover how TFDF-based perfusion technology boosts lentiviral vector production by over 10-fold, slashes costs, and accelerates the commercialization of CAR-T and other advanced cell therapies.
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The Hidden Costs Of Paper Logbooks
Stop losing time and capacity to manual paperwork. Learn how digital workflows eliminate compliance risks and unlock the actionable data needed to optimize life sciences manufacturing.
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Optimizing DPI Production: Filling Technologies For Precision And Performance
Developing effective dry powder inhalers requires expertise across multiple disciplines, from particle engineering and device technology to manufacturing science and regulatory knowledge.
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Challenges And Solution In The Poly (A) Control For Plasmid And mRNA
Poly(A) tail integrity is critical for mRNA stability and translation. Advanced strategies optimize plasmid design, transcription, and purification to ensure consistent poly(A) control for therapeutic success.
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Select The Best Analyte: A Guide To Effective Mycoplasma Testing
As you build a Mycoplasma testing strategy to ensure drug safety, there are three analyte types to choose from: live Mycoplasma, RNA, and genomic DNA, each offering distinct advantages.
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A Better Immune Response To Vaccination: Using Lymphoid Follicle Organ-Chips
Discover a first-of-its-kind human LF-Chip containing B, T, plasma and antigen-presenting cells to test functional immunization responses to vaccines and adjuvants in vitro.
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Optimizing Performance For De-Risked Lentiviral Vector Production
Discover a de-risked, reproducible, and scalable platform for efficient GMP manufacturing of lentiviral vectors that maximizes titers and enriches recovery through upstream and downstream optimization.
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Understanding EndoCleave's Role In Viral Vector Manufacturing
Achieving high-quality viral vectors demands rigorous control over contaminants. Learn about enzymatic approaches to significantly reduce nucleic acid impurities in your manufacturing processes.
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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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