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Transitioning to GMP production? Learn how to prevent equipment setbacks, build manufacturer partnerships, and foster a strong compliance culture

GMP Essentials for Successful Research-to-Production Transitions

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Futuristic digital illustration of a DNA double helix glowing in blue and pink, symbolizing gene therapy.

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Avoid the top pitfalls in scaling gene therapy production by mastering tech transfer, GMP compliance, and workforce alignment

Scaling Gene Therapy Production: From Bench to Clinic

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Lab Manager

Join<em>&nbsp;Lab Manager</em> and our experts as we discuss GMP practices

Mapping Chambers Simplified: Where To Place Sensors &amp; Why

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New Orbital Shakers Deliver Enhanced Reliability and Sustainability

Thermo Fisher Scientific

The new line of Solaris Benchtop Temperature Controlled Orbital Shakers will evolve alongside the researcher

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How to ensure a successful validation process

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Streamlining the qualification process results in better business outcomes and increased productivity

Achieving GMP/GLP Compliance through More Efficient Equipment Validation

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Inspection outcomes depend not only on clinical factors but how you handle the inspection process

How to Prepare for a FDA GxP Inspection

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SciNote

ELN Features Critical to GMP and GLP Compliance

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Successfully integrate cGMP into your building and lab operations

Overcoming the Obstacles to Locating a cGMP Facility in Institutional Settings

Gene therapy concept. Medical technology. Medtech.

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Flexible and scalable nonviral delivery for cGMP cell therapy processing

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Figure 3. Gating strategy for the Attune NxT Flow Cytometer.

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Figure 5. Gene editing efficiency. The dark blue bar represents the percent of cells expressing the integrated CAR sequence (knock-in), light blue represents knockout, and grey represents the unedited or wild type population

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Figure 4. Cell viability 72 hours post-electroporation in the CTS Xenon system.

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Figure 6. Phenotypic data post-electroporation. The dark blue bar represents CD4? cells, the light blue bar represents CD8? cells, and the grey bar represents either double positive or double negative CD4/8 cells. Below the bar charts is phenotypic characterization before activation, electroporation, and culture

Figure 1. Autologous T cell therapy workflow.

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Figure 2. Experimental conditions and electroporation parameters.

Scale and Optimize Your Cell Therapy Processing

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Large-Scale Nonviral Delivery for Cell Therapy

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Graphical depiction of a user-generated electroporation pulse profile.

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The effects of voltage, pulse width, and pulse number on transfection efficiency and post-electroporation viability as determined by design of experiment (DOE).

Viability in CAR T cells. Cells were assessed for viability after 72 hours using Trypan Blue Solution. For the three donors, cell viability on the CTS Xenon system ranged from 64.6% to 83.6%.

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Allowable electroporation parameters based on power and temperature limits of the instrument and chamber.

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Knockout and knock-in performance in CAR T cells. Cells were characterized after 72 hours as untransfected (TCR??+, gray), knocked out but not knocked in (TCR??–CAR–, light blue), or as successfully knocked out and knocked in (TCR??–CAR+, dark blue). Across all donors, successful knock-in percentages on the CTS Xenon system ranged from 21.9% to 45.6%, exceeding the values on the Neon system.

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Products that meet your need at every step of the workflow, from research through commercial manufacturing

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Preservation of CD4 vs. CD8 T cell ratio. CD4 and CD8 T cells were identified by flow cytometry. Non-electroporated cells (condition 0) were gated on live, single, and untransfected (TCR??+ cells), while electroporated cells were gated on live, single, and knocked out (TCR??– cells). Proportions of CD4 (dark blue) and CD8 (light blue) T cells remained largely consistent between non-electroporated cells and cells electroporated with the Neon system (100 ?L) and with the CTS Xenon system (1 and 9 mL).

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Large-scale nonviral delivery for cell therapy

Flexible Solutions that Facilitate Scale-Up&nbsp;

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Joining Processes And Software For a Streamlined, Quality-First Laboratory

The Benefits, Business Case, And Planning Strategies Behind Lab Digitalization

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Plas-Labs

The Lab Safety Blueprint

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PerkinElmer

Accuracy and Reliability in Trace Element Analysis

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Strategies for More Efficient, Compliant, and Reliable LC-MS/MS Workflows

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