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

1. De-Mystifying And De-Risking Process Development Through Early Engagement With A CDMO 11/27/2018

   An overview of how CDMOs can help companies get started in the world of CGT manufacturing, with considerations around timing of engagement to maximize commercial and clinical success.

2. Virus Reduction Of An Affinity Capture Step: Viral Clearance For Protein A 5/17/2019

   Learn more about how HiScale 10/40, packed with MabSelect PrismA, is a reliable choice for the capture step in a virus clearance study.

3. Cloud-Based OEE Monitoring For Pharma And Biotech 10/10/2019

   Competitive pressure and tight budgets are forcing pharmaceutical and biotech manufacturers to make optimum use of their existing facilities. Cloud-based OEE monitoring provides real-time insights into equipment performance – with quick and easy deployment and expansion, zero maintenance overhead and near-instant ROI.

4. Recruiting Hard-To-Find Patients From A Specific HLA Subgroup 12/26/2018

   CRO helps company overcome early patient screening failure rate of 70 percent as well as assisting with instituting new protocols and renegotiating contracts as the study experiences and major change of direction.

5. Flow Cytometry–Based Exosome Detection And Analysis Using The ZE5 Cell Analyzer 12/28/2018

   Compare flow cytometry–based exosome detection methods using the ZE5 and demonstrate that exosomes can be directly detected without being attached to beads.

6. Validating The Stability And Durability Of Labels After Thawing From Cryogenic Temperatures 2/26/2019

   One important element of working in cryogenic temperatures involves ensuring labels remain intact and securely adhered to packaging after application as product moves from ambient temperatures to cryogenic temperatures to thawing at the point of use. The following study serves as a model for the need to validate label stability and adherence and is an example of the many different types of validation studies we regularly conduct to mitigate risk for customers during all phases of an advanced therapy clinical trial.

7. Expanded Droplet Digital PCR Multiplexing Capability Using Two Different Strategies 10/23/2019

   Droplet Digital PCR (ddPCR) enables easy multiplexing of numerous targets within each fluorescent channel. Amplitude-based multiplexing achieves this by varying primer and/or probe concentrations. In probe-mixing multiplexing, probes are mixed at desired concentrations to place targets in a defined position on a 2-D plot. This paper describes strategies for both approaches using the large portfolio of ddPCR Assays readily available through Bio‑Rad.

8. Sorting Bone Marrow Mesenchymal Stem Cells With The S3 ™ Cell Sorter 12/28/2018

   In this study, a S3 Cell Sorter was used to analyze and purify prospective MSCs from passage 1 (P1) and passage 3 (P3) bone marrow cultures. The data presented here shows the capability of the S3 Cell Sorter to isolate rare MSCs from a mixed bone marrow culture with satisfying sort efficiency and postsort purity.

9. Quality System Overview For GMP Manufacturing 11/26/2019

   When you think about cell and gene therapies (CGTs), what most often comes to mind is the early stage scientific innovation responsible for finding new ways to treat diseases. Unfortunately, what is sometimes overlooked or left to the last minute is the less-than-glamourous, but still critical, manufacturing steps that ensure a new, potentially lifesaving treatment reaches patients in a safe and reliable form. Following is an overview of the mandatory quality systems and functions that are required within a standard GMP facility to comply with ICH Guidelines including Q7 and EU ATMP guidelines, Canadian GMP (C.002) and U.S. FDA, PHS Act section 351/361 and CFR 21 Parts 210/211 and Part 11 as they apply to cell and gene therapy. Other guidelines are considered, as required, such as ISO 9001:2015 certification.

10. Total Transportation Management Saves Company $10.2 Million 9/20/2018

    A leading multinational pharmaceutical company approached Fisher Clinical Services with an extensive clinical trial pipeline and the need to achieve a comprehensive, fully-managed transportation strategy. Learn more about our outsourced transportation option that delivered tangible results.