Cell therapy products challenge traditional particulate controls. One expert explains detection, mitigation, and contamination prevention.
- Reassessing Nanoparticle Immunotoxicity: From Well-Established To Novel Approaches
- Building CGT Manufacturing Capacity For The Next Commercial Era
- Managing The Presence Of Visible Particulates In Cell Therapies
- FDA Approval Of TREGZI Signals A New Era For Precision Engineered Cell Therapy
- Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis
- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program
- Wondering If Your Org Should Purchase R&D Datasets?
- Mapping Early-Phase Supply Chain Bottlenecks That Doom Pipelines
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![The Benzonase® Endonuclease Success Story]( "Business Continuity Management: The Benzonase® Endonuclease Success Story")
Business Continuity Management: The Benzonase® Endonuclease Success StoryBusiness continuity management is a key success contributor to the pharma industry. Explore best practices for a robust supply chain and how they can translate into success stories.
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![GettyImages-1166528597-scientist-lab-equipment-tubing]( "Automated PUPSIT For Drug Product Applications")
Automated PUPSIT For Drug Product ApplicationsAutomated filtration systems streamline PUPSIT, leak testing, and integrity checks to ensure sterile drug product processing. Learn how these methods improve contamination control and compliance.
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![bio-manufacturing-GettyImages-2194012901]( "Understanding And Implementing USP <665> For Single-Use Systems")
Understanding And Implementing USP <665> For Single-Use SystemsNew expectations for single-use systems require structured risk assessment and extractables testing. As compliance deadlines near, practical guidance aligns science, knowledge, regulatory readiness.
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![GettyImages-1931925757-assay-well-plate-pipette-red-liquid]( "Flow Cytometric Analysis: Differentiation Potential Of Human Stem Cells")
Flow Cytometric Analysis: Differentiation Potential Of Human Stem CellsExplore an assay kit that simplifies handling with a methylcellulose-free medium and clear flow cytometric readout, which enhances automation and high-throughput sample acquisition for versatile research.
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![CPC - aseptic processing]( "The Case For Modernizing Small-Volume Aseptic Processing")
The Case For Modernizing Small-Volume Aseptic ProcessingTube welding and biosafety cabinets present significant costs and risks for small-volume aseptic processing. Modern single-use aseptic connectors offer a more efficient alternative.
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![GettyImages-675822742 bioreactor]( "Addressing The Challenges In Lentivirus Harvest Clarification")
Addressing The Challenges In Lentivirus Harvest ClarificationTraditional depth filtration struggles with lentiviral harvest clarification, leading to low yields and high costs. However, single-use centrifugation offers a promising alternative.
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![GettyImages-675822224-cleanroom-lab-manufacturing]( "Ultra-Low Cross-Linked Microgel Purification")
Ultra-Low Cross-Linked Microgel PurificationULC microgel purification is often slowed by linear polymer contamination and limitations of centrifugation. Explore how hollow fiber TFF improves filtration efficiency and supports scalable processing.
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![GettyImages-2160715445-female-scientist-computer-lab-coat]( "Automating High-Throughput Screens Using Patient-Derived Organoids")
Automating High-Throughput Screens Using Patient-Derived OrganoidsMany oncology drugs fail in later development stages due to inadequate predictive models. Explore how 3D cell models, like patient-derived organoids, offer a promising solution in the drug development process.
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![GettyImages-2193981966-dna-helix-built-molecule]( "Rapidly Assess Drug Response In 2D And 3D Breast Cancer Model Systems")
Rapidly Assess Drug Response In 2D And 3D Breast Cancer Model SystemsFor years, 2D cell cultures have been crucial in drug discovery. Explore how 3D cultures offer more biologically relevant models today that enhance cancer research and drug efficacy assessments.
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![GettyImages-1327460931 biomanufacturing]( "Single-Use Technology And Environmental Responsibility In Biopharmaceuticals")
Single-Use Technology And Environmental Responsibility In BiopharmaceuticalsLearn about strategies such as regional manufacturing and advanced single-use systems and their potential to minimize carbon footprint and enhance sustainable biomanufacturing.
NEWSLETTER ARCHIVE
- 07.16.26 -- Why Fit-For-Purpose Manufacturing Is Becoming The Defining Strategy In CGT
- 07.15.26 -- Human-Centric Models For Modern Drug Development
- 07.15.26 -- FDA's Guidance On Cell And Gene CMC Codifies Flexibility
- 07.14.26 -- STREAM Edition: The Facility Master Planning Playbook With Herman Bozenhardt
- 07.14.26 -- Advancing Autologous Stem Cell Engineering For Diabetes And Vision Loss
- FDA Approval Of TREGZI Signals A New Era For Precision Engineered Cell Therapy
- How CGT Developers Should Think About Manufacturing Models, Hybrid Strategies, And Scale
- In Vivo Gene Editing Is Moving From Promise To Proof
- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
- CGT Manufacturing Shifts From Capacity To Strategy
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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