Companies often underestimate the complexity of standing up an eQMS. These are five of the most common issues that lead to regulatory and GMP exposure risk.
- Proteomics Tools: A Resurrection
- Powering AI And Synthetic Biology In Therapy Design
- Six Specialized Modalities Testing CDMO Readiness In 2026
- Green Supply Chains Rarely Start With A Pledge; Target Waste Instead
- The Real Reason We Haven't Fully Automated Cell Therapy Yet
- Process Engineering's Key Role In Sterile Injectable Facility Design
- What To Know About — And How To Apply For — FDA's PreCheck Pilot
- Breaking Through Tumor Defenses With Next-Generation Cell Therapy
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
Streamline Your mAb Manufacturing With Strategic Development And CDMO Compatibility
Though the journey to mAb development begins at lab scale, for clinical trials and commercial distribution, a production process must be streamlined and scalable to 2,000 L production and above.
-
Accelerating Approval Pathway For Phase III Ovarian Cancer Trial
A late-stage biotech developing a first-in-class therapy for a rare, chemo-resistant form of ovarian cancer sought help for accelerated FDA approval.
-
3D Cell Culture Reveals Undetectable Drug Efficacy In Traditional Systems
Drug discovery now targets cancer stem cells (CSCs) to achieve long-term tumor eradication, which moves beyond traditional chemotherapeutics. Discover an advanced screening platform that better predicts CSC inhibitor efficacy.
-
Demonstration Of Scalability For A Novel Fixed Bed Reactor Platform
Designed to enable efficient scalability, a new FBR platform allows operators to use one technology, with a standardized workflow, for their process development, scale-up, and manufacturing processes.
-
Injection Site Reaction Screening Methodology
Optimize drug formulations for solubility at physiological pH to reduce injection site reactions, enable high-concentration dosing, and enhance patient comfort and compliance.
-
Redefining The Analytical Frameworks Surrounding Capsid Characterization
Modern AAV manufacturing demands precise capsid characterization to distinguish empty, partial, and full particles, as regulators now require rigorous purity and potency control for clinical safety.
-
Quality Assurance In IVT RNA Vaccine Development Using Electrophoresis
Discover advanced solutions for IVT RNA synthesis, focusing on enhancing fidelity in throughput, innovative technologies, and methodologies to optimize your RNA research and development processes.
-
mRNA Therapeutic Development Through Enhanced IVT Capping Efficiency
See how Codex HiCap RNA Polymerase supports the production of high-performance synthetic mRNA, paving the way for next-generation mRNA therapies.
-
End-To-End Workflow Integration For Antibody Development
Modern antibody discovery generates massive, fragmented datasets that slow collaboration and decision‑making. Examine how unified digital workflows streamline R&D and improve data quality.
-
Supporting Complex Manufacturing For Liquid And Lyophilized Drug Products
Aseptic fill and finish operations gain efficiency and precision with modular isolator technology, inline weight checks, and lyophilization, which are ideal for mRNA-LNPs and other sensitive modalities.
NEWSLETTER ARCHIVE
- 03.06.26 -- New Podcast Episodes: Therapeutic Power Of Fibroblasts, Curative Cell Therapies, Breakthrough HER2 Immunotherapy
- 03.06.26 -- Simplifying Friction In Cell Therapy Clinical Trials With Dr. Panteli Theocharous
- 03.05.26 -- Regulatory, Payer & Distribution Insights For CGT Success
- 03.05.26 -- Process Engineering's Key Role In Sterile Injectable Facility Design
- 03.04.26 -- Breaking Through Tumor Defenses With Next-Generation Cell Therapy
- Powering AI And Synthetic Biology In Therapy Design
- Inside Mesoblast's Playbook For Making Allogeneic Cell Therapy Real
- Disciplined CGT Will Win On 2026 Regulatory Flexibility
- ARM's Tim Hunt On Expanding Patient Access, Smarter Regulation, And A More Sustainable Market In 2026
- Global Shifts And Strategic Resilience Will Shape CGT In 2026
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.
More Content Collections