Status of the Quality System Team – June 27, 2025
Work in progress … **************** T cell–Engaging Immunotherapies Pose a Predictable but Complex RiskT cell–engaging bispecific antibodies (BsAbs), particularly those targeting CD3 and a tumor-associated antigen, have emerged as a powerful class of immunotherapies. These agents leverage endogenous T cells to induce targeted tumor cell death, often achieving deep and durable responses in hematologic malignancies….
Introduction The modular µSiM device allows for active flow and continuous monitoring, but the acrylic-needle interface may experience incomplete sealing over longitudinal studies, so the need for an adaptable and intuitive approach for leak-free bottom-channel flow arose. Jordan Jones, Ahmet Gurcan, and Kevin Ling adapted the flow inserts to develop Flow Bumpers, a PDMS-adhesive component…
The μSiM Vasc-SkM Microphysiological development can be separated into 4 parts: Media tuning for integrated culture Force sensing element setup Assembly of the μSiM Vasc-SkM and setting up the perfusion Transendothelial Electrical Resistance (TEER) measurement of the Vast component Work has been done on the first 2 parts. Media tuning for integrated culture In order…
CRE_Bispecific_Antibody_CRS_and_ICANS_Neurotoxicity_Guidance_Feb2024 51899285fnl_Immunotoxic Potential of PharmaceuticalsWe are considering Bispecific T cell engagers (BiTEs) [1] as an alternative to a CAR T driven cytokine release as an immunotherapy focused DDT. BiTEs are monoclonal antibodies engineered to have one arm that recognizes a T Cell surface antigen and another that recognizes a tumor antigen. There are number of…
Introduction Over the past few months, I have been characterizing and comparing iPSC-derived monocytes (iMonocytes) with peripheral blood-derived (PB) monocytes. As I wrap up these experiments, we’ve decided to look at marker expression on iMonocytes and PB monocytes once they have been polarized to macrophages by culturing the iMonocytes or PB monocytes with HTEN051 fibroblasts…
The following site may be useful to draw to people’s attention when specifying objectives on the Etaluma: https://www.microscope.healthcare.nikon.com/microtools/resolution-calculator/#Focus I have configured a custom resolution calculation using the sensor data supplied by Etaluma, here exemplified at 10x/0.3NA: To take account of the shorter tube lens (which gives ¼ magnification expected cf Nikon 200mm tube) I have…