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
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CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Solutions For CQA Analysis Of IVT mRNA-Based Biotherapeutics
Discover new innovative solutions for mRNA analysis, enhancing accuracy and efficiency in IVT mRNA workflows, including advanced technologies and methodologies to optimize your research and development processes.
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Surveying Amino Acid Variability Among CHO Media
Variability in amino acid levels across CHO media can affect growth and product quality. Learn why real-time monitoring and proactive control strategies are key to improving process consistency.
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Optimized Product Recovery Using The Drug Product Filtration System
Explore strategies to maximize drug product recovery during sterile filtration, minimize hold-up volume, and reduce dilution after PUPSIT to ensure higher yield, improved efficiency, and less waste.
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The Need For Adaptive Distribution Partners For Cell And Gene Therapies
Optimize your commercial strategy by exploring how adaptive distribution models navigate reimbursement challenges and improve patient access. Partner early to align workflows and ensure operational success.
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Nucleic Acid-LNP Ultrafiltration And Diafiltration
Downstream filtration can make or break LNPs at scale. See how membrane format, loading, and shear affect recovery and stability — and how alternative TFF lowers scale‑up risk.
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Mold In Cleanrooms: A Persistent Threat And The Case For Proactive Bio-Decontamination
Learn how a comprehensive investigation and systems-level bio-decontamination strategy successfully eliminated persistent mold contamination in a vaccine manufacturing facility's high-risk area.
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Use Cation Exchange Chromatography For High Yields In Vaccine Production
Learn how to achieve high yields in vaccine production by using Cation Exchange Chromatography for purifying SARS-CoV-2 spike proteins. This method provides high purity and minimizes protein aggregates.
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GLP-1 Peptides Around The World
Explore how evolving regulations, supply constraints, and reimbursement models shape GLP-1 drug development across the U.S., Europe, and Asia.
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Novel Cardiotoxicity Evaluation Method Using iPS-Derived Cardiomyocytes
Discover how real-time monitoring of glucose and lactate in iPS-derived cardiomyocytes reveals subtle drug-induced metabolic shifts that traditional screening methods often fail to detect.
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Supporting Global Approval Of A First-In-Class Gene Therapy For A Rare Genetic Disorder
Global approvals for a first-in-class gene therapy don’t happen by chance. See how adaptive oversight and inspection readiness kept a complex rare disease program moving forward.
NEWSLETTER ARCHIVE
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- 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
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