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The quality and purity of the plasmids are critical for subsequent applications. Creative Biogene has a well-established quality management system and is committed to implementing strict quality control throughout the GMP plasmid production process to provide customers with high quality products.
Quality control is critical to GMP plasmid production because it ensures that the product is of consistently high quality and meets regulatory requirements. It helps to identify problems at an early stage, prevents contamination, and ultimately improves the efficiency of the production process. Creative Biogene provides high quality quality control solutions to ensure the consistency and reliability of plasmid products.
Creative Biogene's plasmid preparation implements the most stringent quality control standards, and services can be customized to meet your quality and quantity demands. The following are the control items we perform in quality control:
Physical characteristics control is an important component of quality control in plasmid GMP (Good Manufacturing Practice) production. Physical control consists mainly of the assessment of the physical characteristics of plasmid DNA, including appearance, concentration, pH, extractable volume, osmolarity, and dispersibility.
To ensure the safety and efficacy of the final product, Cteative Biogene uses enzyme digestion identification and sequencing technologies to test the integrity of the plasmids to ensure that the product delivered to our clients will meet its intended use.
We test the purity of the plasmids and possible impurities in the production process by performing the following tests:
Safety testing is an important component of GMP plasmid production. These components help ensure that the final product is free of contaminants and does not cause any adverse effects on the organism, making it safe and effective for use as a therapeutic. Creative Biogene offers safety testing for bacterial control, virus safety, endotoxin control, sterility testing, bioburden testing, and toxicity testing.
Stability testing during GMP plasmid production ensures the safety, efficacy and quality of plasmid DNA in clinical trials or commercial applications. Creative Biogene offers stability testing for plasmid integrity, viability, endotoxin levels, sterility and long-term storage.
Creative Biogene's comprehensive quality control solutions accelerate the detection of challenging samples and provide timely feedback. Our range of fast, accurate and reproducible assays has become the standard in GMP production. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.
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