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

• Mid-Sized Pharma Optimizes Local Affiliate Safety Operations

  Managing local affiliate PV strains any team. See how a mid-sized biopharma standardized ICSR processing across 94 countries, improved compliance tracking, and achieved centralized oversight.

• 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.

• Phase-Appropriate Approaches To Manufacturing And Testing

  Accelerate the development of high-quality biopharmaceuticals by implementing phase-appropriate, risk-based manufacturing and testing strategies that ensure timely progression.

• 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.

• Evaluating Carryover When Using A TOC Analyzer

  Accurate TOC results shouldn’t depend on sample order. See how low-level measurements remain reliable even after high-TOC analysis, helping reduce false positives and streamline decisions.

• Ex-Vivo T Cell Depletion In Allogeneic HSCT

  Explore a flexible cell depletion strategy that selectively removes targeted immune cell populations while preserving beneficial subsets, supporting tailored graft engineering approaches.

• Direct Cell Lysis Enables Rapid And Robust Vector Copy Number (VCN) Quantification Using QIAcuity Digital PCR

  Explore a faster approach to vector copy number measurement that replaces DNA extraction with direct cell lysis and digital PCR, delivering accurate, reproducible results across fresh and frozen samples.

• Integrated Upstream And Downstream Strategies For Robust Manufacturing

  Process robust mAb production requires understanding scale dependent cell environments, leveraging predictive models, and pursuing data driven control to minimize variability and optimize quality.

• Pouching Solutions For Sterile And Moisture-Sensitive Devices

  Aseptic pouching requires specialized mechanical segregation and sterile vacuum handling. Discover how targeted engineering maintains Grade A compliance.

• Comparison Of Different Methods To Isolate HMW DNA From Bacteria

  Different extraction methods produce dramatically different DNA sizes and qualities, directly affecting long‑read sequencing results. See how performing early QC can improve sequencing success.