Gmp-compliant Isolation
Gmp-compliant Isolation - Related Videos
06:47
A GMP-Compliant Procedure for the Generation of Gene-Modified T cells
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Cited by 1 •
2023
This protocol outlines the process of transducing primary human T cells with a gene of interest, ensuring compatibility with Good Manufacturing Practice (GMP) standards.
03:15
Screening of Cyclic di-GMP Modulators Using Bacteria Expressing a Fluorescent Reporter Protein
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2025
Source: Rugjee, K. N., et al. Establishment of a High-throughput Setup for Screening Small Molecules That Modulate c-di-GMP Signaling in Pseudomonas aeruginosa. J. Vis. Exp. (2016).This video demonstrates the screening of cyclic di-GMP modulators using genetically modified bacteria that express green fluorescent protein (GFP) under the control of a c-di-GMP-sensitive promoter. Fluorescence is measured in a multi-well plate containing different test compounds. Compounds that inhibit c-di-GMP...
12:11
Capture Compound Mass Spectrometry - A Powerful Tool to Identify Novel c-di-GMP Effector Proteins
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Cited by 14 •
2015
The ubiquitous second messenger c-di-GMP controls growth and behavior of many bacteria. We have developed a novel Capture Compound Mass Spectrometry based technology to biochemically identify and characterize c-di-GMP binding proteins in virtually any bacterial species.
11:31
Establishment of a High-throughput Setup for Screening Small Molecules That Modulate c-di-GMP Signaling in Pseudomonas aeruginosa
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Cited by 2 •
2016
This article describes the high-throughput assay that has been successfully established to screen large libraries of small molecules for their potential ability to manipulate cellular levels of cyclic di-GMP in Pseudomonas aeruginosa, providing a new powerful tool for antibacterial drug discovery and compound testing.
09:44
Large-Scale Cell Production Based on GMP-Grade Dissolvable Porous Microcarriers
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Cited by 4 •
2023
Here, we present a protocol to achieve the large-scale manufacturing of adherent cells through a fully closed system based on GMP-grade dissolvable microcarriers. The cultivation of human mesenchymal stem cells, HEK293T cells, and Vero cells was validated and met both quantity demands and quality criteria for the cell and gene therapy industry.
FAQs
Validation demonstrates that an isolation procedure can be performed as intended and can repeatedly support the required quality and safety expectations. It also provides a documented basis for using the procedure in a regulated setting. By relying on validated handling steps rather than informal variation, laboratories can improve reproducibility and make batch results easier to evaluate.
Qualified equipment helps keep separation and recovery steps controlled, while contamination-control measures protect the material during handling. Together, these safeguards address microbial contamination, mix-ups, and unintended changes that could compromise the isolated biological material. Their importance extends beyond the isolation step because the material may become a starting input for later research or manufacturing activities.
Traceability links the isolated material to its documented handling history, allowing a batch to be reviewed rather than treated as an unexplained result. Complete records can show how the material was managed within the controlled process and support evaluation of reproducibility, quality, and safety. This record-based approach is particularly important when biological materials enter regulated development or manufacturing.
Consistency depends on controlling more than the separation itself. Validated procedures, qualified equipment, documented handling, and protection from contamination work together to limit process variation and preserve the intended material. This coordinated control helps investigators distinguish genuine biological performance from changes introduced during isolation, which supports more reliable assessment of cells, tissues, microorganisms, or other starting materials.
A compliant workflow brings together a validated isolation procedure, qualified equipment, documented handling steps, and contamination-control measures during separation and recovery. The process should also preserve records sufficient for traceability and batch review. These elements provide a controlled route from biological input to isolated material without requiring assumptions about specific instruments, laboratory conditions, or product-specific operations.
Researchers may apply these controls when isolating cells, tissues, microorganisms, or other biological starting materials. The relevant choice depends on the material and its intended role in research or manufacturing, but the same GMP emphasis remains: controlled handling, protection against contamination, and records that support consistent evaluation. This broad scope connects laboratory biology with regulated product preparation.
Cell-based therapies and biologics are prominent contexts because their materials can directly influence product performance and patient protection. GMP-compliant isolation supports these applications by emphasizing reproducibility, contamination control, and complete batch documentation. Those records help teams evaluate how consistently the material was prepared and provide evidence for reviewing its suitability within a regulated process.