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

• Rare Disease Trial Strategies

  This white paper focuses on clinical trials, aligning the latest trends in rare disease R&D viewed through the lens of gold-standard clinical intelligence. From this emerges practical recommendations regarding clinical trial design, stakeholder engagement, and patient recruitment.

• Quantification Of Large Oligonucleotides Using High Resolution MS/MS

  Explore how to achieve sensitive, high-resolution analysis of large oligonucleotides, with the opportunity to perform both qualitative and quantitative analysis in a single run.

• Microcarrier Delivery System For Reduced Bioreactor Set Up Time

  This paper evaluates a gamma irradiated, ready-to-use microcarrier delivery system that reduced bioreactor set up time by approximately by 20%.

• Filling Industry Gaps With Dedicated Cell & Gene Therapy Fluid Transfer Sets

  Read how the incorporation of transfer sets designed to support CGTs will aid in the implementation of controllable, consistent, and safe cGMP amenable manufacturing procedures.

• Tuning Intermediate Volumes On Sepax™ C-Pro Cell Processing System

  Discover how we automate the optimizing cell harvesting process and further minimize the potential for cell loss during wash steps.

• Successful Preparation Strategies For NDA/MAA Marketing Applications

  No two new drug applications (NDAs) or marketing authorization applications (MAAs) are the same. Learn the key strategies that can be implemented to propel even the most complex submissions to successful regulatory conclusions.

• Particulate Contamination Levels In Single-Use Systems

  We investigate material adsorption of mRNA-encapsulated lipid nanoparticle (LNP) formulation comparing the Aramus fluoropolymer bag to commonly used glass vials and polypropylene (PP) cryotubes.

• Optimization Of AAV Production For High-Yielding And Scalable GMP Processes

  By leveraging a standardized, scalable platform approach for viral vector manufacturing, including the transient transfection step, timelines can be accelerated to bring next-generation therapies to market.

• Raman vs. MIR Spectroscopy For Mammalian Cell Culture Monitoring

  A direct comparison between the two technologies was conducted to investigate which system is more suitable for analyzing mammalian cell culture(s).

• Manufacturing Platform & Media Strategy Matters For Mesenchymal Stromal/Stem Cell Production Economics

  Biopharmaceuticals need to scale up from laboratory to commercial production at a key point in their development and thus need clearly defined process economics to achieve critical velocity toward commercial success.