Gmp-compliant Manufacturing
Gmp-compliant Manufacturing - 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 15 •
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.
01:26
Steel Manufacturing
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2024
Steel manufacturing is a multi-stage process that begins by smelting iron ore into cast iron in a blast furnace. This initial stage involves layering iron ore with coke, a type of fuel, and crushed limestone within the furnace. The coke is ignited with a high volume of air, leading to the creation of carbon monoxide, which acts to reduce the iron ore to pure iron. During this smelting process, limestone plays a crucial role by forming slag. Slag captures impurities within the molten iron, such...
FAQs
Validated processes demonstrate that manufacturing steps can perform consistently, while qualified equipment is shown to operate as intended. Together, they reduce process variability and help preserve a product’s identity, strength, quality, and purity. These controls are especially important for biologics, where consistent production supports reproducible laboratory findings and dependable products for clinical use.
Documentation records how materials, equipment, personnel, processes, testing, and release decisions were managed. Traceability connects the final product with its manufacturing history and raw materials, making results easier to review and discrepancies easier to investigate. This documented record supports regulatory oversight, reduces the risk of mix-ups, and strengthens confidence in product consistency.
Consistency depends on coordinated control of raw materials, facilities, equipment, personnel, processes, and testing. Trained staff follow established procedures, controlled facilities help limit contamination, and qualified equipment supports repeatable operations. Testing then evaluates the resulting product. Managing these factors together is more effective than relying on final testing alone to detect variability.
The workflow begins with controlled raw materials and continues through defined manufacturing processes using qualified equipment and controlled facilities. Personnel document activities, perform appropriate testing, and maintain traceability throughout production. Before release, the accumulated records and test results support a decision about whether the product meets expected identity, strength, quality, and purity requirements.
In immunology and infection research, GMP principles support the consistent manufacture of vaccines, antibodies, immune-based therapies, and related products. Applying controlled processes and documented testing helps limit contamination, mix-ups, and batch-to-batch variability. The resulting consistency supports laboratory studies while also helping products progress toward clinical use under regulatory oversight.
GMP controls create a structured connection between laboratory development and clinical production. Validated processes, traceable records, qualified equipment, and controlled facilities help make manufacturing reproducible and scalable. This evidence supports regulatory review and increases confidence that a vaccine, antibody, or immune-based therapy can be produced with reliable quality as development advances.