CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Rescuing A Global Program For NDA Success

  Explore the collaboration that enabled FDA approval of a novel chronic-condition therapy, rescued a high-risk program, and demonstrated a unified “one-team” approach by reworking the sponsor's SAP.

• Advanced Sequencing Approaches For Comprehensive AAV Vector Characterization

  Short and long read sequencing offer complementary insights into AAV vector identity, integrity, and impurity profiles, helping developers improve safety, efficacy, and scalability of gene therapy products.

• Efficient Monitoring Of Escherichia Coli Feeding Strategies

  Consistent, contamination-free sampling is critical for reliable bioprocess data. Automation enables frequent, hands-free collection, improving efficiency and insight while reducing manual workload.

• NGS Analysis Of Hereditary Cancer Predispositions

  Examine how a molecular genetics team improves NGS efficiency and library quality through streamlined automation, intuitive QC tools, and reliable workflows, boosting reproducibility.

• Cell Collection Basics For The Transplant And CGT Industries

  Breakthroughs in CAR T-cell and stem cell therapies depend on mastering cellular collection. Understanding these fundamentals is vital for advancing treatment efficacy and patient outcomes.

• Optimized Urine Liquid Biopsy Workflow

  Urine-derived cell-free DNA is revolutionizing liquid biopsy research to offer a non-invasive, accessible tool for early disease detection, monitoring, and comprehensive diagnostics across oncology.

• Development Strategies For Adenovirus-Based Gene Therapies

  Scaling up viral vector production can be challenging, and ensuring consistent titers and activity requires careful optimization and technical expertise.

• Developing Consistent And Reproducible 3D Spheroid Models

  Improve 3D spheroid consistency by optimizing cell selection, seeding density, and plate geometry. See how practical workflows and comparative data help reduce variability and establish reliability.

• NDA Success Strategy: Using Non-US Clinical Data In An NDA Submission

  A sponsor acquiring a therapeutic asset from an overseas company sought assistance when including foreign clinical trial dat,a generated outside a U.S. IND, in a New Drug Application (NDA).

• Data-Driven CHO Bioprocess Optimization And Scale-Up

  Learn how at-line cell culture media analysis enhances mAb production by refining nutrient feed strategies, reducing toxic metabolites, and improving yields while lowering costs.