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Potency test is a key step in Good Manufacturing Practice (GMP) viral vector production. This test is designed to evaluate the biological activity of viral vectors and is important to ensure the quality and consistency of the product. Creative Biogene offers well-established tests to characterize the potency of viral vectors. Our independent quality control team reviews manufacturing and quality control processes for compliance with defined guidelines and regulations, and performs comprehensive quality control testing at critical time points to assess the efficacy of the final product.
Potency test is performed throughout the viral vector production process, including multiple steps of viral vector production, purification, and final product acquisition. The assessment of potency is also critical to demonstrate batch-to-batch consistency and stability of viral vectors after a period of storage. To fully characterize the viral vector potency, we perform tests such as titer assays, empty particle to whole particle ratios, etc. In addition, we offer infectivity and cellular potency assays, including transgene expression and functional assays of host cells.
Product-specific potency assays are developed to demonstrate biological activity in each finished batch, a key quality attribute of the vector.
The titer of viral vectors is an important factor affecting the efficacy of gene therapy and is one of the key components of viral vector quality control, including viral genome titration and infectivity titration. Viral titers are usually determined by measuring the capsid protein or viral genome. Creative Biogene provides accurate and reliable quantification by qPCR and other techniques.
Empty Particle to Full Particle Ratio Test
In the process of viral vector preparation, except for the complete viral vector containing full-length DNA genome, a certain percentage of viral particles do not contain any DNA genome, which are called empty viral particles. The presence of a large number of empty viral particles may affect the effectiveness and safety of viral vectors and cause cellular immunotoxicity. Creative Biogene applies a range of methods, including cryo-transmission electron microscopy (cryo-TEM), volume exclusion chromatography (SEC) and analytical ultracentrifugation (AUC), to efficiently determine total and infectious particle counts.
Infection efficiency testing typically involves incubating viral vectors with target cells in vitro and monitoring the expression of the protein of interest using various methods, such as immunofluorescence staining or flow cytometry. The efficiency of viral transduction is then quantified by measuring the percentage of cells expressing the protein of interest.
With extensive expertise and technology, Creative Biogene offers comprehensive characterization programs to assess the potency of viral vectors to ensure a high-quality product for you. Contact us for more information on viral vector potency testing and we will be happy to assist you.
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