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SciNote

ELN Features Critical to GMP and GLP Compliance

Whitepaper

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Successfully integrate cGMP into your building and lab operations

Overcoming the Obstacles to Locating a cGMP Facility in Institutional Settings

Article

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.

Thermo Fisher Scientific

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;

Genetic engineering concept. Medical science. Scientific Laboratory.

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Automated PBMC isolation and T cell wash and concentration

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Figure 1. Simplified cell therapy workflow.

Figure 2. The CTS Rotea Counterflow Centrifugation System.

Figure 3. PBMC isolation using the CTS Rotea system. (A) Viability and recovery of PBMCs and (B) relative proportions of cell types present in an unprocessed Leukopak bag and after PBMC isolation.

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Figure 6. Average recovery and viability for two T cell wash and concentrate runs with an input of 5 x 10? cells.

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Table 3. T cell wash and concentrate protocol.

Figure 4. T cell expansion. (A) Expansion of T cells isolated using the CTS Rotea system and a density gradient medium. (B) Characterization of the expanded T cells isolated using the CTS Rotea system and a density gradient medium.

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Figure 7. T cell washing and concentration. (A) T cell recovery and viability averaged over ten T cell washing and concentration runs. (B) Flow cytometry after staining of CD4 and CD8, before and after the CTS Rotea system washing and concentration protocol. (C) CTS Rotea system operating software with a chamber of T cells in a fluidized bed.

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Figure 5. Recovery and viability for T cell washing and concentration with 5 mL, 10 mL, and 20 mL output volumes.

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Improve Your Process and Manufacturing in Cell and Gene Therapy

Cleanroom Environmental Monitoring Systems

Lighthouse Worldwide Solutions

Cleanroom monitoring systems help meet regulatory compliance and mitigate risk 

Track Western Blot Workflows

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Traceability in Western blot imaging: Considerations for GxP

PromoCell GmbH receives EXCiPACT™ certification as manufacturer of pharmaceutical excipients to Good Manufacturing Practice 

PromoCell

The company&rsquo;s entire cell culture media and reagents portfolios are covered by the new certification

PromoCell GmbH Receives EXCiPACT&trade; Certification as Manufacturer of Pharmaceutical Excipients to GMP Standards

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Continuous Active Air Monitoring

guidance on continuous air monitoring, contamination control, key updates to industry standards, and solutions for microbiological quality control.

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Continuous air monitoring, isokinetic sampling, and the advantages of gelatine filters&nbsp;

Does Your Production Environment Meet Today&rsquo;s Air Monitoring Standards?&nbsp;

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Integration of Sartorius Cubis® II Premium Balances into STARLIMS™ from Abbott Informatics

Learn how Sartorius and Abbott Informatics developed a complete computerized solution for a professional integration of Sartorius Cubis &reg; II balances into STARLIMS&trade; covering all cGMP/cGLP aspects 

Integration of Sartorius Cubis&reg; II Premium Balances into STARLIMS&trade; from Abbott Informatics

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Why Performance, Cost, and Environmental Impact Now Compete in Procurement 

When Lab Innovation Meets Sustainability

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The Architecture of Your Brain Model Determines Your Data

The Decisions that Define Your Lab's Environmental Footprint Thumbnail

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Corning Life Sciences

The Decisions That Define Your Lab&rsquo;s Environmental Footprint

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BRANDTECH Scientific

Integra

INTEGRA Biosciences

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NuAire

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NXT Power

From Instruments to Infrastructure: Implementing and Scaling Lab Automation

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GMP

ELN Features Critical to GMP and GLP Compliance

Overcoming the Obstacles to Locating a cGMP Facility in Institutional Settings

Scale and Optimize Your Cell Therapy Processing

Flexible Solutions that Facilitate Scale-Up

Improve Your Process and Manufacturing in Cell and Gene Therapy

Cleanroom Environmental Monitoring Systems

Track Western Blot Workflows

PromoCell GmbH Receives EXCiPACT™ Certification as Manufacturer of Pharmaceutical Excipients to GMP Standards

Does Your Production Environment Meet Today’s Air Monitoring Standards?

Integration of Sartorius Cubis® II Premium Balances into STARLIMS™ from Abbott Informatics

When Lab Innovation Meets Sustainability

Sponsored

The Architecture of Your Brain Model Determines Your Data

The Decisions That Define Your Lab’s Environmental Footprint

From Instruments to Infrastructure: Implementing and Scaling Lab Automation

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