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

• Gene Therapies In Hemophilia

  Potentially curative gene therapies for hemophilia are getting closer to market, representing a transformation in care for many thousands of patients. Download the available white paper to find out more.

• Targeting Once Inaccessible Phospho-Proteins With RePlex

  Vividion Therapeutics is a small molecule company harnessing its expertise in target biology, chemistry, and mass spectrometry to transform the future of human health. They were frustrated with their process when monitoring quantitative phospho-protein changes as it was notoriously problematic and slow. By transferring their assays over to Simple Western™ with Jess™ combined with Jess’ RePlex™ module they are able to increase throughput and improve the accuracy of his phospho-protein quantification.

• N-1 Perfusion High Inoculum Fed-Batch For Reduced COGS And Easy Retrofit

  A mid-to-large biopharma wanted to increase productivity 2-3× in their fed-batch facility and and also reduce their current cost of goods (COGS). With one small change in the upstream (USP) seed train, the customer was able to meet their goals.

• Performance Challenging Fetal Bovine Serum (FBS) And FBS Alternatives

  An independent commercial testing lab conducted two separate and sequential growth promotion studies to underscore the need for pre-purchase lot performance testing with: (1) FBS, and (2) FBS alternatives.

• Great Size ≠ Great Value: How Smaller Outsourcing Partners Benefit Small And Emerging Biotechs

  Large clinical research outsourcing partners tout extensive expertise or experience based on past success. But pulling back the curtain on this “corporate memory” often reveals inefficiencies caused by “that’s the way it’s always been done” thinking.

• Scaling A mAb Production Process To A Single-Use Platform

  The transfer of mAb production processes between scales, referred to as scale-up or scale-down, is difficult. This study reviews moving mAb production from a microscale bioreactor to a single-use platform.

• Building Modular Cleanrooms For Pharma At Warp Speed

  As the life sciences industry responds to the COVID-19 pandemic in record fashion, cleanroom technologies have proven vital to efforts to combat the COVID-19 pandemic.  In 2020, cleanroom provider AES Clean Technology introduced new offerings under their existing Faciliflex banner, delivering complete custom cleanrooms from scratch in as little as four months from concept initiation. 

• Clinical Supply Global Optimization: Managing Complex Global Drug Distribution And Expiry

  A global top-ten pharmaceutical company was sponsoring a complex, 8-year Phase III trial across 43 countries. The Sponsor was under intense pressure to reduce trial costs and leverage internal resources. Ultimately, study sites began to run out of medication. They realized that the trial could be better managed if it was outsourced. 

• Optimized Cell Culture Medium For Scalable Viral Vector Production

  MilliporeSigma’s new cell culture medium offers an improved alternative to classical formulations that can help address the constraints in viral vector manufacturing and scale-up.

• A New Approach To Cell Sorter Safety

  Cell sorting continues to be a powerful contributor in the quest to improve human health, allowing researchers to make timely advancements in drug and vaccine development. However when cell sorters are run at high pressures, they can produce aerosols with high particulate content as well as extremely small particles. While several newer sorters include systems to address this concern they continue to resemble an ad hoc solution with manual operation of air-handling controls and poor access for service manipulation, which can lead to inconsistent results and an unsafe environment. In this paper we review a cell-sorter with a design to solve these problems.