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

• Osmolality Is A Predictor For Model-Based Real Time Monitoring Of Concentration In Protein Chromatography

  The bottleneck for real time control and real time release is lack of product-specific in-line sensors or fast at-line
  methods suitable for model-based prediction of process outcome. Learn how osmolality as an at-line method is an excellent predictor together with UV280 and UV260 for protein quantity in model-based prediction using partial least squares methodology.

• Analytical Quality By Design Based Method Development For The Analysis Of Valsartan And Nitrosamines Impurities Using UPLC-MS

  In this paper we demonstrate how using the AQbD approach and automated software helps gaining a deep knowledge about the method and as a result developing a highly robust and reproducible method.

• Strengthening The Drug Manufacturing Supply Chain During Extraordinary Times

  Learn more about a successful strategy for increasing supply security through improving the resilience of manufacturing operations.

• Anticipating The Next Decade Of Gene Therapy

  The next decade will bring improvements including the development of alternative approaches to gene delivery, and advances in upstream and downstream processing, analytical methods and intensified/continuous processing.

• Process Automation In Cell & Gene Therapy: Navigating Upstream

  Read how automation, online sampling, and smart technologies can streamline cell culture monitoring in cell and gene therapy development processes.

• The Future Of The FDA: Operating In An “Electronic World”

  Explore the FDA's e-transformation that promises to usher in a new era of electronic interactions between the agency and its constituents.

• Method Optimization: Assay Development Following Compendial Methods

  There was a short time frame of only 7 weeks to complete assay optimization and conduct pre-validation studies within the confines of USP<621>.

• 5 Advantages Of A Single-Use Manifold Configurator

  The interface between systems and bags or bottles often proves a bottleneck. Learn how to adapt single-use filling assemblies to meet changing needs in the production and filling process.

• 8 Ways Osmolality Tests Improve Cell & Gene Process Dev, Manufacturing

  Challenges remain to be solved in making cell and gene therapies accessible to larger patient populations. Cell and gene therapy development can benefit from emerging and novel uses for osmolality testing in advanced therapy production.

• Improve Viral Stability For Vaccines And Gene Therapies

  We review the use of Exbumin, a blood-free recombinant human serum albumin that has been used in hundreds of thousands of injections.