Eli Lilly and Company's one-team mindset aims to templatize facility design while remaining nimble enough to react to new manufacturing breakthroughs.
- Field Notes: APEC RHSC's Workshop On ATMP Development And Evaluation
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- How To Implement Post-Approval Changes On A Global Level
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- Target Selection Drives The Future Of CAR T Therapy In Solid Tumors
- Mastering Biotech's Insourcing/Outsourcing Trade-Offs
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CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Single-Use Assembly Capabilities To Keep Pace With Biopharma Dynamics
Discover how a vendor-independent partner assists global life science companies and CDMOs with innovative single-use technologies to mitigate risks and ensure uninterrupted manufacturing.
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The Importance Of Quality In Raw Material Selection
Learn how to select high-quality raw materials for cell-based manufacturing in this exploration of the criticality of raw materials, from preclinical development to commercialization.
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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.
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12.5x Titer Boost Accelerates CAR-T Program To IND Filing
Plasmid engineering and process development boosted viral titer 12.5×, eliminating manufacturing bottlenecks and enabling an on‑time regulatory submission for the cell therapy program.
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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.
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Comparing Process Development Approaches For Recombinant Proteins
Explore how adding a traceless tag enables streamlined affinity purification for recombinant proteins, and how this approach compares with a conventional process in development time, recovery, and purity.
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Achieve Higher Targeted Concentrations
Single-pass TFF streamlines downstream processing by reducing footprint, shear exposure, and hold-up volumes. Learn how this approach is advancing efficiency across therapeutic and vaccine production.
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What FDA CRLs Reveal About E&L
FDA feedback shows E&L gaps still delay approvals. This preview flags common issues — from unknown compounds to weak tox data — and offers ways to strengthen E&L approaches and cut regulatory risk.
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The Importance Of Quality Proteins For Research, Development, And Manufacturing
Learn how validated testing, strict sourcing, and regulatory guidance help minimize endotoxin contamination risks and support reliable therapeutic development in advanced medicinal products.
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Simultaneous Extraction Of Mycoplasma, MMV, And Vesivirus Nucleic Acids From A Single Sample
Achieve early detection of cell culture contamination with a nucleic acid extraction system to provide an integrated system for rapid and sensitive detection of mycoplasma, MMV, and vesivirus.
NEWSLETTER ARCHIVE
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- 04.16.26 -- Cell & Gene Capabilities That You Need to Know
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- 04.15.26 -- Faster, More Efficient Cell & Gene Therapy Workflows with ddPCR
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