When lyophilizing a challenging biologic drug product, use an integrated approach optimizing formulation and process parameters together.
- Your 7 Decisions To Make Before MES Configuration
- Complete Response Letters For CGTs Share This Common Theme
- Finding The Therapeutic Window: Using Single-Cell Biology To Build More Selective T-Cell Engagers
- DEA Reveals Hidden Costs Of Analytical Validation Guidelines
- What LSPA's Life Sciences Future Says About The Road Ahead For CGT
- FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
- CDMO Selection Beyond Capabilities And Price
- August 2026 — CDMO Opportunities And Threats Report
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
Confident Sialic Acid Identification With MS/MS
Traditional mass spectrometry left uncertainty around potentially immunogenic glycans. Learn how a biologics developer achieved regulatory-ready clarity.
-
High-Yield Cell Therapy Bioproduction
Producing billions of dental pulp stem cells strains static culture and complicates harvest. A closed planar perfusion approach offers another route, with scale-up lessons from one developer.
-
Successful SwissMedic Marketing Authorization Application For An Oncology Therapy
See how strategic EU dossier adaptation and Swiss-specific regulatory expertise enabled a successful SwissMedic submission and accelerated market access for an oncology therapy.
-
RNA Nanoparticle: Formulation, Process, And Characterization
Explore the current state-of-the-art in RNA nanoparticle formulation, examining the technologies and strategies used to optimize RNA delivery for preclinical and clinical development.
-
Immunohistochemistry In Precision Medicine: From Biomarker To Clinical Trial Assay
From preclinical validation to clinical implementation, immunohistochemistry (IHC) is essential in understanding target biology and ensuring drug safety and efficacy.
-
Enhance Access And Improve Retention In Rare Disease Trials With HTS
Home Trial Support (HTS) provides a solution to improving participant recruitment and retention during musculoskeletal studies.
-
Why Compliance-Driven CDMOs Win Sponsor Contracts
Learn how digital maturity and compliance excellence are reshaping CDMO competitiveness, as well as strategies that strengthen performance and accelerate tech transfers.
-
Challenges And Solution In The Poly (A) Control For Plasmid And mRNA
Poly(A) tail integrity is critical for mRNA stability and translation. Advanced strategies optimize plasmid design, transcription, and purification to ensure consistent poly(A) control for therapeutic success.
-
Expansion Of Human Bone Marrow-Derived MSCs
Achieving over 870 million viable, quality mesenchymal stem/stromal cells is possible. This efficient cell culture method scales bone marrow-derived MSCs for clinical needs.
-
Seamless Workflow For Environmental Monitoring
Learn how connected sampling tools and compliant monitoring software improve data integrity and streamline compressed gas testing workflows, offering a path to reliable environmental monitoring.
NEWSLETTER ARCHIVE
- 10.16.26 -- Manufacturing Solutions For Scalable Cell Therapy Production
- 10.16.26 -- Traversing Complexity In Breast Cancer Clinical Development
- 10.15.26 -- Your Vector Is Deciding The Path Of Your Cell & Gene Therapy Program
- 10.15.26 -- Which Viral Clearance Step Delivers The Highest LRV?
- 10.15.26 -- A Sponsor's Guide To Smarter Viral Vector CDMO Partnerships
- Inside The Next Phase In Autoimmune CAR T From Meeting On The Mesa 2026
- What LSPA's Life Sciences Future Says About The Road Ahead For CGT
- Inside Scaling Next-Gen MSCs Without Scaling Risk
- Inside Kyverna's Autoimmune CAR T Platform Beyond SPS
- Autoimmune CAR T Has Hit A Critical Moment. Are We Asking The Right Questions?
EDITORIAL COLLECTIONS KNOWLEDGE CENTER
Our Editorial Collections examine today’s biggest scientific, operational, and patient-centered drug delivery issues. These collections help companies navigate complex development decisions with in-depth analysis, real-world examples, and guidance from industry experts
More Editorial Collections
