Quality System Update (June ’25)
Status of the Quality System Team – June 27, 2025 Quality System Update – 27 June 2025
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A DDT for ICANS Risk Assessment in T Cell–Engaging Bispecific Antibody Immunotherapies: Strategy and Rationale
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….
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μSiM Vasc-SkM update 2025.06.24
Since the last TraCe-bMPS update in April, we continued to explore different conditions to optimize the μSiM hVasc-SkM systems to obtain stable results. Enhanced imaging for PDMS beams with Rhodamine staining Previously we established a MATLAB program that detects the border of the PDMS beams and converts the movement of the PDMS beam from myobundle…
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2025 Rochester MPS Day
The 2025 Rochester MPS Day Summary provides an overview of the event, highlighting registration details, participant feedback, and suggestions for future improvements. The event had a total of 130 registrations, with 88 in-person and 26 virtual attendees. Participants represented various organizations, including the University of Rochester, RIT, Duke, NIH/NCATS, and several industry partners. Feedback indicated that…
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CRS Generated from Bispecific T Cell Engagers (BiTEs)
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…
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IMR90 EECM-BMEC-Like Cells Lack P-gp Efflux Activity
Introduction During the January TraCe-bMPS progress meeting, Jon Flax presented some interesting findings in the iPSC-derived extended endothelial culture method brain microvascular endothelial cell-like cells (EECM-BMECs, hereafter referred to as BMECs) [1]. While these BMECs tended to have high expression of most transmembrane transport proteins, they had relatively low expression of p-glycoprotein (ABCB1/MDR1) (Figure 1)….
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Establishing Flow Bumper Supported Basal Flow in Incubator & Best Practices
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…
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Modeling Basal Flow in Comsol
Introduction Our goal was to develop a COMSOL model for the bottom channel of the µSiM that can be accessed and easily used by anyone with a COMSOL license. Previously developed simulations for the µSiM rely on the CAD import module, which can introduce unnecessary complications with regards to accessibility and ease-of-use, particularly to expand…
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μSiM Vasc-SkM update 2024.03.13
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…
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On-line Resolution Calculator Applied to Etaluma Objectives
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…
