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

41. Options For Light Scatter And New Opportunities For Research 6/13/2021

    The field of flow cytometry is rapidly maturing, and instrumentation is constantly improving. However, many researchers are frustrated by instrument limitations that make it difficult or impossible to observe small particles that are likely present in samples, yet are undetectable. This paper characterizes the use of unique light scatter parameters and describes additional features such as below-the-trigger-threshold detection, extremely low background signal, and superior electronics that make the Bigfoot Spectral Cell Sorter well suited for micro- and nanoparticle research.

42. Allogeneic T-Cell Therapies: Efficient Commercial Manufacturing Readiness 7/13/2020

    Our "manufacturing by design" approach for addressing the industrialization of cell therapies allows for optimal production conditions. This methodology was applied to a generic allogeneic T-cell-based process to propose a robust, scalable, cost-effective, and sustainable allogeneic platform.

43. Evaluating The Stability Of Therapeutic Biosimilar Monoclonal Antibodies With Micro-Flow Imaging 1/28/2021

    Biosimilars are a class of molecules that are identical to innovator drugs by amino acid sequence, and represent an attractive opportunity, particularly when those innovator drugs go off patent. To ensure similar quality, efficacy, and safety, certain critical quality attributes (CQA) must be assessed. Here we show how we use MFI to evaluate the stability of two therapeutic monoclonal antibodies, trastuzumab and bevacizumab, and their biosimilars.

44. Preclinical CAR-T Cell Target Safety, Biodistribution, And Tumor Infiltration Analysis Using The RNAscope® ISH Assay 3/1/2021

    In this report we illustrate a way to detect activated CAR-T cells in the tissue context, as well as low expression of CAR target antigen, using the RNAscope® in situ hybridization (ISH) technology.

45. Purification Of mRNA By Affinity Chromatography On CIMmultus® Oligo dT Column 6/7/2021

    Increasing demand for messenger RNA (mRNA) as therapeutic product requires efficient and scalable purification methods. In this application note a CIMmultus® Oligo dT, a monolithic stationary phase is used for purification of mRNA from a capping mix of Luc2 RNA. The large channels and convective mass transfer within the stationary phase eliminate shear forces and allow high flow rates, which leads to very short purification times and high recoveries.

46. The Value Of Gene Therapy In Spinal Muscular Atrophy 3/11/2021

    A client was developing a potentially curative gene therapy, they needed to translate the clinical benefit into economic terms to engage payers and health technology organizations. By working with the client to develop a cost-effectiveness and budget impact model for a gene therapy in SMA that overcame unique challenges of modeling an early childhood neuromuscular genetic disorder they were able to change the prevailing mindset on how SMA progression is characterized.

47. A Fixation Protocol Compatible With R&D Systems Luminex Assays Enabling Analysis With Infectious Samples 2/22/2021

    A common way to inactivate infectious material is to use formaldehyde fixation. Confirmation of microorganism inactivation is accomplished using viability testing with broth or growth media for bacteria and plaque assays for viruses. Unfortunately, chemical fixation using formaldehyde has been shown to alter cytokines and chemokines in such a way that an immunoassay would not properly quantify biological samples. To address this issue, we decided to test the hypothesis that R&D Systems Luminex Assays are compatible with standard fixation protocols.

48. Business Continuity Program: Maintain Operations During Crises 5/5/2020

    Get insights into implementing a robust business continuity management program that can help secure supply, reduce risks, and maintain quality in manufacturing operations, through a crisis situation.

49. Getting Creative: A Hybrid Answer When The Conventional Won’t Do 3/2/2020

    A small oncology-focused biotech company presented such a challenge when seeking to contract out its data management services. This CRO combined outsourcing, insourcing, and geographic flexibility to devise a hybrid solution.

50. Simplifying And Expediting Inflammatory Biomarker Research With Ella 3/19/2021

    The Global Forum on Childhood Pneumonia estimates that 11 million pediatric lives will be lost by the year 2030 if more global action is not devoted to accelerating research efforts against this disease. Among the actions required, is a commitment to research partnerships and breakthrough innovations to both advance our understanding of the immune response during infection and identify earlier time points for therapeutic intervention. Read on to learn how a team of clinician-scientists at Penn State Health are working to address this challenge using Simple Plex assays on Ella.