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

51. A Novel CAR-T Cell Therapy Approach Using Fluorescence-Activated Cell Sorting And Stem Cell Transplantation 9/14/2020

    Successful chimeric antigen receptor- (CAR-) T cell therapy requires a target antigen that is unique to cancer cells. But what happens when there are no unique antigens? Researchers at Columbia University Medical Center addressed this problem by replacing healthy non-target cells with genetically modified versions lacking the CAR-T cell target (Borot et al., 2019). Their results, published in PNAS, may provide a new avenue for treatment of some types of cancer.

52. Factoring The “What Ifs” Into Supply Forecasting 8/24/2020

    This paper discusses considerations for developing a supply plan, the influence of early decisions and impact on outcome as a trial progresses, and how decisions can put patients and the trial at risk.

53. Full Service Support For A Gene Therapy Trial 11/2/2020

    A clinical-stage biotechnology start-up asked Veristat to run complex US and EU trials of their unique gene therapy. Veristat brought invaluable global capabilities and expertise to a small client team tackling their first clinical-stage program without the large infrastructure or resources to conduct studies in this space themselves. Our end-to-end support started at Phase I and will continue into post-marketing and regulatory follow-up.

54. Sterilizing Grade Filtration Unit Operations For Plasmid DNA Processes 11/19/2020

    The large size of pDNA can present a challenge for sterile filtration unit operations within your gene therapy manufacturing since the product can be retained by the filters, leading to both yield loss and low filtration capacity. Optimization of a sterilized grade filtration unit can help increase yield and filtration capacity. Read on to learn more!

55. Controlled Endpoint In Cryopreservation 2/24/2020

    Successful cryopreservation of cells requires a controlled cooling rate. Cooling too rapidly or too slowly could lead to a poorer outcome. This application note demonstrates how controlled-rate cooling is achieved using equipment such as VIA Freeze controlled-rate freezers.

56. Considerations For Bioreactor Process Development And Scale-Up For Transient Transfection-Based Lentivirus Production In Suspension 9/14/2020

    Several challenges are associated with use of an adherent platform for lentivirus production. This white paper describes considerations for suspension-based, transient transfection bioreactor process development and scale-up of lentivirus production. We will describe the approach taken for process development.

57. Have Confidence In Your Bio/Pharma Data 11/17/2020

    The pharmaceutical industry has grown from simple aspirins to IV delivery, antibiotics and, most recently, cell and gene therapy. Products are more complex, tailored and varied than ever and the associated amount of data is growing - which requires a new level of attention to detail. Learn what features tolook for when choosing a data management system to establish compliant data visibility across teams, sites and partners and establish data integrity throughout the product life cycle.

58. Lipid Nanoparticles Are Having A Breakout Moment 9/3/2020

    After more than 25 years of commercial use with almost 20 parenteral drug products, lipid nanoparticles (LNPs) are having a breakout moment. While LNPs are now a proven drug delivery technology to penetrate target cells and ensure release for reliable systematic or local delivery, their true market potential as a gene and cell therapy enabler has only become clear to many since COVID-19.

59. Trends In Protein Separation And Analysis — The Advance Of Stain-Free Technology 4/7/2020

    Stain-free technology, a technology that existed in principle since early 2000 but was only commercialized in 2010 has changed the protein separation and analysis landscape in the past few years. This article focuses on how protein visualization is accomplished using stain-free technology, its advantages and concerns as well as how stain-free technology can change the way we carry out protein separation and analysis.

60. Single-Use Systems For Storing And Shipping Frozen Drug Materials 5/20/2019

    The logistics of decoupling drug substance manufacturing from final drug product formulation is now possible using integrated single-use freeze-thaw assemblies which incorporate reliable components.