Cell And Gene Articles, App Notes, Case Studies, & White Papers

1. Best Practices For A Successful Bioprocess Technology Transfer 9/10/2019

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

2. Commercial Scale Manufacturing of Allogeneic Cell Therapy 11/26/2019

   Allogeneic cell therapy products are generating encouraging clinical and pre-clinical results. Many of these therapies are also expected to have large market sizes and require cell doses of ≥10⁹ cells. As therapeutic technologies mature, it is essential for the cell manufacturing industry to keep pace to adequately support commercial scale production. To that end, there is much that can be learned and adapted from traditional manufacturing fields. In this review, we highlight key areas of allogeneic cell therapy manufacturing, identify current gaps, and discuss strategies for integrating new solutions.

3. Solution To Ensure Quantity And Quality Of The Excipient Polysorbate-80 In Drug Formulations 6/10/2019

   Excipients are valuable substances used to improve stability and potency, but sourcing and stability of the excipients themselves can be a challenge. To address this need, we developed a two-method solution to evaluate one such excipient, PS-80, for quantity and quality. This novel approach has multiple applications for drug developers looking to utilize PS-80 in their final product.

4. Delivering The Global Expertise Required To Coordinate A Pediatric Gene Therapy Trial 5/4/2020

   A European biotech company was conducting a pediatric trial involving a rare, incurable genetic disorder. In addition to new regulatory considerations, this trial also called for an extremely challenging intracerebral administration. To succeed, they needed a partner that could develop a clear, compliant strategy for obtaining informed consent and implementing an innovative data management plan to track patients between surgical and clinical sites.

5. Regulatory Challenges For Viral Vectors For Cell And Gene Therapy 7/24/2020

   Frost & Sullivan's Virtual Think Tank series brought together leading minds in the cell & gene space to discuss current regulatory issues and key challenges in viral vector manufacturing.

6. Utilizing The Multiparameter Capability Of The ZE5 Cell Analyzer To Monitor T Cell Exhaustion And Effects Of Immunotherapy 3/16/2020

   When working with limited patient samples, the ability to test multiple parameters simultaneously is highly valuable. This application note reviews how to successfully monitor in-depth changes to the T cell phenotype, exhaustion, and cellular subset identity markers using a 16-parameter panel developed for use with a 5-laser ZE5 Cell Analyzer. Using an in vitro model, they examined T cells before and after chronic stimulation, and in combination with a PD-1 receptor inhibitor, nivolumab.

7. Sorting An Old Problem: Are Cells Stressed By Fluorescence-Activated Cell Sorting? 9/14/2020

   Fluorescence-activated cell sorting is a valuable tool for research, allowing separation of a mixture of cells into distinct populations for analysis. But could the physical forces of sorting stress the cells, altering their behavior and confounding experimental results? Andrä et al. (2020) found that although cell sorting activated p38 MAPK stress signaling, no functional or structural changes were observable. The results indicate that jet-in-air systems such as the Bio‑Rad S3e Cell Sorter do not alter cell behavior.

8. Key Considerations For Laboratory Facility Design Planning And Optimization 11/6/2020

   Laboratories are an integral part of the pharmaceutical industry. They are used at each stage of the product development. See how this solution allows you to plan projects without having to build new labs and gain the ability to plan projects better, inventory management, being nimble in responding to demand fluctuations, avoidance of under and/or over utilization of talent and reliable capital project planning that is based on actual utilization tracking.

9. Cell Therapy Scale-Up Strategies For Commercial Success 9/30/2020

   This article discusses options for cell therapy process development and validation that minimize risks through quality control (QC), optimization, scaling, closing, automation, and assay development.

10. Process Characterization: Ready For The FDA? 3/6/2020

    Realizing the benefits of process characterization requires proper planning and application of a comprehensive process characterization strategy.