Eli Lilly and Company's projects in the U.S. include greenfield sites where little infrastructure exists. Here's how the company's approaching the challenge.
- UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk
- February 2026 — CDMO Opportunities And Threats Report
- COGs And Biology, Two Endpoints Needlessly At Odds In Advanced Therapy
- The Long Road To U.S. Vaccine Manufacturing
- Compliance, Costs, And Site Readiness In CAR-T Clinical Trials
- All The Ways Global Biopharma Still Grapples With Annex 1
- Managing Operational Challenges In CAR-T Clinical Trial Logistics
- FDA's 483 Playbook: What It Means For Pharma Outsourcing — And What It Doesn't Address
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
High-Throughput Lipid Separation For LNP Formulations
Lipid nanoparticles (LNPs) carry immense potential as delivery systems. Learn about the development of isocratic and gradient methods for high-throughput separation of lipids used in LNP formulations.
-
Formulation Development Of Enterically Protected Spray Dried Dispersions
Adrulipase spray-dried dispersions were evaluated to create an orally delivered, enteric-protected enzyme. The lead formulation provided the best acid protection, rapid release, and stability.
-
Navigating Commercial Logistics For CGTs: A Roadmap To Scalable, Patient-Centered Success
The commercialization of cell and gene therapies requires a precise and resilient logistics model that can adapt to rapid demand and global expansion while maintaining a patient-first approach.
-
Navigating Project Optimus And The Rapidly Changing Oncology Development Landscape
Project Optimus and adaptive trial designs are reshaping oncology development, improving patient outcomes, and streamlining approval pathways.
-
Scaling Of Impingement Jets Mixing For LNP Drug Production
Delve into the intricacies of Impingement Jets Mixing (IJM) technology and its pivotal role in the scalable and reproducible production of Lipid Nanoparticles (LNPs) for drug delivery.
-
A Scalable Manufacturing Platform For The Purification Of Stem Cell Derived Exosomes
EV production scale increases require paired robust, scalable, and cost-effective downstream processes. Process parameters can be tailored for therapeutic exosome programs and allow for maximum exosome recovery.
-
Correlating NGS Success With Sample Input Quality: A Large Scale Study
DIN values offer a data‑backed way to identify which DNA samples are ready for successful sequencing. With strong correlations to sequencing performance, DIN thresholds help streamline workflows.
-
Alternative Two-Step Mixed-Mode Approach To A mAb Purification Process
Two post–Protein A capture two-step mAb processes were developed and compared to an archetypical three-step mAb purification process using two IEX steps after Protein A capture.
-
Scale-Up Approaches For Culturing Adherent Cells
For successful scale-up, see how optimizing process parameters such as attachment methods, gassing, and agitation can help reduce cell environmental stress, ultimately improving productivity.
-
Enhancing Novel Developability Through Automated MS Analytics
Growing biotherapeutic complexity demands MS workflows that can unify diverse datasets. Learn how automated approaches enhance data quality, streamline analysis, and support faster development.
NEWSLETTER ARCHIVE
- 03.23.26 -- 5 QMS Blind Spots You Should Know About
- 03.20.26 -- Lessons From Bringing A New T Cell Class For Autoimmune Diseases To Clinic
- 03.19.26 -- Your Guide To AAV Success: Characterization, QC, And Viral Clearance Strategies
- 03.19.26 -- Powering AI And Synthetic Biology In Therapy Design
- 03.18.26 -- Advance Your MSC Process: New Research, Expert Talks, And Scaling Solutions
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