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

• A Plasma Problem: Dwindling Supply In The Face Of A Growing Demand

  An outlook on the market shows plasma fractionators will have to look to innovation and other opportunities for supply, in order to meet the needs of patients.

• Pairing Data Connectivity, Automation Ease Tech Transfer/Scale-Up

  In biopharma, process data is used in many ways throughout process development and production phases. This article outlines how connectivity and comprehensive automation ease tech transfer and scale up.

• Allogeneic T-Cell Therapies: Efficient Commercial Manufacturing Readiness Using “Manufacturing By Design” Methodology

  Contract development and manufacturing organizations need to play a critical role in the scale-up and industrialization of cellular therapies by providing customized  tools and processes. The Manufacturing by Design approach for addressing the industrialization of cell therapies allows for optimal production conditions.

• Bulk Drug Substance Logistics – Primary Packaging

  There are currently many options of primary packages on how to transport the drug substance from A to B. This paper explains the benefits and shortcomings of a few of those options.

• Best Practices For A Successful Bioprocess Technology Transfer

  A well-executed bioprocess technology transfer is critical to ensure smooth knowledge transfer and optimal process reproducibility. 

• Optimizing Cell Culture Media: Increase Titer With Maintained Protein Quality

  When evaluating media with the goal of increasing titers, it is important to ensure that protein quality is not negatively impacted. Here's how the process improvement can be performed reliably.

• How COVID-19 Is Making Operationalizing Gene Therapy Trials Even Tougher – And How We Handled It

  The global pandemic has exacerbated the operational challenges intrinsic to gene therapy at the site level, the project team level, and the sponsor level. To ensure that studies continue to move forward, strategies need to be considered not only for operational efficiency and patient centricity but also as contingency planning in the case of a subsequent wave or quarantine. Here we continue our case study of a rescue Phase 1/2 gene therapy trial involving localized administration of gene therapy using specialized equipment with a look at the operational challenges of these trials during COVID-19.

• Unravel The Complexity Of Single Cell Natural Killer Cell Cytotoxicity And ADCC Mediation

  Current experimental methods to characterize NK cells rely on bulk measurements of heterogenous samples that often contain contaminating cell types. In this application note, we demonstrate how NK cell function can be assessed at the single-cell level to characterize both cytotoxicity and ADCC mediation in the presence of target cells.

• Factoring The “What Ifs” Into Supply Forecasting

  Growing urgency in the biopharmaceutical industry to speed new products to market leads to greater appreciation for supply forecasting as a strategic and highly complex success factor. Review considerations for developing a supply plan, the influence of early decisions and their impact on outcomes as a trial progresses, and how decisions can put patients and the trial at risk.

• LV Scale-Up Workflow In Single-Use Bioreactors For GMP Compliance

  Cost-effective manufacturing of lentiviral vectors (LV) at commercial scales has proven difficult and remains a pressing issue for the marketing of therapies that depend on their application.