The authors conclude their 4-part article series on computer systems validation (CSV) pitfalls using real case studies to illustrate points related to inattention to details.
- Upgrading The Vial/Vein-To-Vein Process With Enterprise-Level Digital Infrastructure
- mRNA Empowering Engineered In Vivo Cell Therapies
- Cell & Gene Therapy Manufacturing: Considerations For Early-Stage Companies
- Building Frameworks To Support Complex Therapy Manufacturing
- Audit Readiness For Cell & Gene Therapy Companies
- New Regulatory Survey Findings: Biotech Global Market Access Challenges And Learnings
- Host Cell DNA Impurities: A Unique Challenge For rAAV
- Tune Therapeutics' 2025 Epigenome Editing Outlook
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Creating A Sustainable Business Model For Cell And Gene Therapies
Avoid product launch delays and expand patient access to CGTs by understanding and meeting regulatory guidelines and securing approval for reimbursement of treatment costs.
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Characterization Of The Colon Intestine-Chip
Learn about the development and characterization of Organ-Chips and what makes them the most comprehensive model of the colonic epithelial-endothelial interface that is commercially available.
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Optimizing Human iPSC Aggregate And Organoid Production For Bioprinting
This study aimed to identify the optimal cell culture conditions to yield high cell density and maintain high cell viability with consistent aggregate morphology and pluripotency marker expression.
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Natural Killer Cell Expansion And Scale-Up In Vertical-Wheel Bioreactors
Allogeneic Natural Killer (NK) cell therapy offers a promising avenue for cancer immunotherapy. However, traditional platforms struggle to achieve the scalability required for clinical translation and commercial manufacturing.
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Flow Cytometry Analysis Of Chemokine Receptors Expressed On Human NK Cells
Learn how the knowledge generated by a deep and thorough analysis of chemokine receptors on natural killer (NK) cells can be helpful to scientists studying certain cancers and diseases.
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Understanding Biosafety Levels
Compliance with biosafety levels (BSLs) is crucial in ensuring that your laboratories meet stringent standards to protect staff and prevent the escape of biological agents.
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Global Outlook Of Multi-Specific Monoclonal Antibodies: Asia Pacific Focus
Learn about the global clinical trial landscape of multi-specific monoclonal antibodies (Mabs), with emphasis on trends in the Asia Pacific, and recent advancements in the field.
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Process Validation Considerations
Process validation is a crucial step for successful registration and commercial manufacturing. Learn how to determine the right timing and properly apply a risk-based approach.
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Navigating The Global Epilepsy Clinical Trial Terrain In 2024
Explore the forefront of epilepsy research with Novotech CRO's comprehensive analysis, unveiling innovative therapies, clinical trials, and future trends shaping epilepsy care.
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Overcoming Challenges In AAV And LV Viral Vector Manufacturing
Manufacturing viral vectors leaves sponsors vulnerable to high costs, delays, and the possibility of failure. The right CDMO partner can help you reduce timelines and costs for viral vector production.
NEWSLETTER ARCHIVE
- 01.24.25 -- A Phase-Appropriate Approach For Assay Validation In Cell & Gene Therapies
- 01.23.25 -- Tune Therapeutics On Clinical Readiness, Technology Adoption
- 01.22.25 -- Overcoming Barriers To Clinical Trial Participation
- 01.22.25 -- CTMC's 2025 Cell Therapy Manufacturing Outlook
- 01.21.25 -- STREAM Edition: Revolutionizing Cell Therapy Manufacturing With AI
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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