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

• 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.

• ADC Development Grows More Complex — SPR Insights Bring Clarity

  Explore how real-time kinetic analysis reveals how conjugation, linker chemistry, and drug loading influence antibody–antigen interactions, while enabling sensitive detection of anti-drug antibodies.

• Optimize Your Approach To mAb Development

  To meet the growing demand for mAbs and their variants, it is important to leverage opportunities for optimization as well as work with suppliers that have the resources to help your workflow thrive.

• An Innovative, Modular Approach To Flexible Supply Chain Management

  Learn how modular strategies, global coordination, and data-driven decisions help maintain continuity, compliance, and speed amid constant uncertainty.

• Molecular Approaches To Streamline Cell Therapy Product Analytical Testing

  Learn how rapid molecular methods of cell therapy testing like qPCR for mycoplasma, sterility, and lentiviral quantification are key to accelerating product release and timely treatment delivery.

• Automated DNA Size Selection For Flexible NGS Workflow Integration

  Gain insight into automating DNA size selection that shows how optimized bead ratios and programmable handling improve fragment recovery, consistency, and throughput.

• AAV Viral Titering Using Nanoplate-Based Digital PCR

  Examine how nanoplate-based digital PCR streamlines AAV titering, providing faster results and greater accuracy, advancing gene therapy development from the lab to the clinic.

• Improve mAb Purification Process Efficiency With Mixed-Mode Resins

  Does your monoclonal antibody (mAb) purification process have three steps? Are you trying to improve purity, yield, and process economics?

• Rethinking Peptones As First-Line Optimization Tools

  Peptones enhance CHO cell growth, viability, and yield, offering a fast, low-risk way to improve bioprocess performance without major process changes.

• CQA Assessment Of LNP-Encapsulated IVT mRNA

  Learn more about issued guidelines on Critical Quality Attributes for IVT mRNA vaccines and biotherapeutics to focus on drug substance and LNP-encapsulated drug product assessment using an analyzer system.