The final guidance articulates common practices around validation, stability data, and reserve samples that, up until now, had been applied on a case-by-case basis.
- Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation
- A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis
- Inside AstraZeneca's Fully Electrified Cell Therapy Facility
- AI Has Arrived In Biotech CMC Amid Patchwork Governance
- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
- CDMO Selection: Start With The Relationship, Not The RFP
- Why FAT Should Confirm Alignment, Not Reveal Its Absence
- Managing Supply Disruptions In ATIMP Clinical Trials
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Bispecific T- Cell Engager (BiTE) Screening, Automated PipelineView automated, high‑throughput BiTE screening in mammalian cells, enabling rapid discovery of efficacious variants through precise genomic integration and scalable workflows.
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Optimization And Scale-Up Of A Plasmid DNA Production ProcessOptimizing pDNA production in E. coli requires strategic media selection and scale-up planning. Explore a study that identifies ideal conditions for high-yield manufacturing.
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Stabilization Of RNA-Loaded Lipid Nanoparticles By LyophilizationDiscover how lyophilization enhances RNA-based therapeutics by enabling storage at higher temperatures, which simplifies cold-chain logistics while preserving nanoparticle integrity and biological activity.
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Flexible Multiplex Solution For VCN Determination In Gamma-Retrovirus–Transduced CAR-T Cells Using QIAcuity® dPCRSee how a multiplex digital PCR approach enables accurate, reproducible VCN determination in gamma‑retrovirus–transduced CAR‑T cells, supporting streamlined workflows and confident decision‑making.
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Addressing A Critical Drug ShortageA critical drug shortage demanded regulatory action, importation support, and patient program readiness. See how integrated QA, 3PL, and PSP capabilities delivered operational readiness in three months.
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Monitoring Bioprocesses In A Light Environment Using Raman SpectroscopyDiscover an advanced solution to facilitate the implementation of Raman technology at both laboratory and manufacturing scales in a normal light environment.
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Navigating The Challenges Of Large, International Phase III Breast Cancer TrialsIn the competitive landscape of breast cancer research, aligning biomarker testing, regulatory pathways, and regional operations from day one creates a path to faster enrollment and stronger outcomes.
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Quantifying Lentiviral Physical Titer Using The QIAcuity dPCR SystemStreamline lentiviral vector analytics with our direct RT-dPCR method. Achieve precise, reproducible results to accelerate safe, effective gene therapies with enhanced quality control.
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ISO 21973: How To Ensure Full Compliance Throughout Every Step Of The JourneyLearn how ISO 21973, a vital standard for ensuring safe and reliable transport of cell and gene therapies, enhances supply chain efficiency and mitigates risks for the regenerative medicine industry.
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Advancing Oncology Innovation With Adaptive Trial DesignsWhen a biopharmaceutical company developing a novel therapy for solid tumor cancers became concerned with rapid over-enrollment from within a single region, they employed a CRO for assistance.
NEWSLETTER ARCHIVE
- 06.11.26 -- Translating Discovery Into Clinical Success
- 06.11.26 -- Bridging Innovation And Manufacturing In Cell & Gene Therapy
- 06.11.26 -- Why Contamination Control By Design Should Matter To Your CDMO
- 06.10.26 -- Control Contamination In Material Transfer Process
- 06.10.26 -- Bioprocess Innovation In Action: Insights, Expertise, And New Solutions
- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
- CGT Manufacturing Shifts From Capacity To Strategy
- Dr. Peter Marks On Why Gene Therapy May Need A New Regulatory Playbook
- Regeneron Advances In Vivo Gene Therapy For Hearing Loss
- Sana, Mayo Clinic Advance A New Model For Cell Therapy Delivery In T1D
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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