As manufacturing overcapacity reshapes the CGT landscape, success now depends less on access to capacity and more on strategic alignment across development, regulatory readiness, and long-term commercialization.
- The Next Frontier In Women's Cancer Care: Combining Cell Therapy With Immuno-Oncology
- Spine Care Redefined: Autologous Cell Therapy For Degenerative Disc Disease
- A Multi-Agent Audit Intelligence Framework For CDMO Quality Oversight
- Why Contamination Control By Design Should Matter To Your CDMO
- Repeating Sanofi's Ballroom Design On Two Continents
- Early CDMO Engagement For Cell Therapies? CellProthera's CEO Thinks Not
- Closing The MES Value Gap: Why Technology Isn't The Problem
- Prevascularized Bio-hybrid Organ Platforms Are Redefining Cell Therapy Delivery
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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An Innovative Approach To Streamline Raman Implementation
Standard methods for building Raman spectroscopy models are often time-consuming and resource-intensive. Explore one-batch calibration and how its performance compares to other modeling techniques.
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Replicate Bioscience And Cytiva Collaborate To Deliver srRNA-LNP Vaccines
Discover how self-replicating RNA (srRNA) can revolutionize vaccine development with sustained protein expression, lower doses, and fewer side effects to advance next-gen RNA therapeutics.
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Mid-Sized Pharma Optimizes Local Affiliate Safety Operations
Managing local affiliate PV strains any team. See how a mid-sized biopharma standardized ICSR processing across 94 countries, improved compliance tracking, and achieved centralized oversight.
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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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Understand Fluorescence And How It Enhances Scientific Exploration
Deepen your understanding of fluorescence for research, and gain valuable insight into how to select appropriate fluorophores and fluorescent proteins for your experiments.
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Analytical Approach For Bispecific Antibody Quality Study
Bispecific antibody quality control demands advanced analytics to detect mispaired species, assess structural integrity, and confirm potency, ensuring safety and efficacy across diverse therapeutic applications.
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Cell Culture Media Mixing In A Benchtop Single-Use Mixer
Explore how efficient powder-liquid mixing and sterile filtration preserve media integrity and support reproducibility in biopharmaceutical workflows, with promising scalability for larger-volume applications.
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Addressing The Challenges In Lentivirus Harvest Clarification
Traditional 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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The Value Of Human Panel Testing Downstream Of Donor Screening In The Allogeneic Therapy Pipeline
Allogeneic cell-based therapies require rigorous donor screening for adventitious viruses. qPCR-based assays enhance detection accuracy, sensitivity, and specificity, supplementing serological testing to ensure safer drug development and production.
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Shielded BSCs: Regulatory Requirement Or Risk-Based Engineering Solution?
Master the balance between USP <825> aseptic standards and radiation safety. Learn how integrated engineering solutions ensure regulatory compliance while protecting both patients and personnel.
NEWSLETTER ARCHIVE
- 05.21.26 -- Advancing Bioprocessing: Perfusion And Process Intensification Across Modalities
- 05.21.26 -- Regeneron Advances In Vivo Gene Therapy For Hearing Loss
- 05.20.26 -- Streamlined Lentiviral Characterization And QC With Digital PCR
- 05.20.26 -- Tackling The Cell & Gene Therapy Sector's Practical Post-Approval Problem
- 05.19.26 -- Building Integrated cGMP Systems For Autologous Cell Therapies With MassGen's Tatyana Matveeva, Ph.D.
- 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
- Reprogramming T-Cell Access To Solid Tumors Through Improved Trafficking And Entry
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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