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Stability studies of viral vectors for gene therapy are essential to assess susceptibility to factors that may lead to aggregation and degradation, which can affect product activity, safety and quality. Creative Biogene has established a well-established system for evaluating the stability of viral vectors, as required by ICH guidelines. These tests allow for the effective evaluation of key factors that may affect the product life cycle and the continuous optimization of our manufacturing processes to ensure the delivery of high-quality viral vector products to our clients.
Changes in viral vector stability due to degradation, chemical or physical instability can affect the quality of the product and the efficacy of subsequent applications. During the production of GMP viral vectors, stability testing of purified viral vectors should be performed at appropriate storage temperatures, storage spaces to ensure that quality properties are maintained and that infectious titers are not adversely affected during their shelf life. Therefore, stability studies of viral vectors need to be performed by establishing a stability program that is compliant with good manufacturing practice (cGMP). This testing includes checking parameters such as pH, osmotic pressure or the presence of protein aggregates.
With experience in the development of biologics stability assays and detailed knowledge of viral vector manufacturing processes, Creative Biogene has established a series of validated analytical methods for viral vector stability assessment. Our professional quality control team has access to a wide range of advanced technologies to perform comprehensive analyses of the factors that affect the stability of viral vectors.
Stability testing of viral vectors typically involves evaluating their physical, chemical and biological properties over time to ensure their stability and efficacy during storage. Our stability testing includes the following main areas:
| Quality Attributes | Testing Content and Method |
| Physical Characteristics | pH: potentiometry |
| Osmolality: osmometry | |
| Aggregate formation: Dynamic light scattering (DLS), tunable resistive pulse sensing (TRPS), flow cytometry (FC) | |
| Chemical characteristics | Stability of the nucleic acid payload of the viral vector: integrity, purity and degradation over time |
| Biological characteristics | Infectious titer: cell Based |
| Genomic titer: ddPCR | |
| Adventitious agents: in vivo and in vitro assays |
Creative Biogene's quality control team has over a decade of experience in viral vector development and stability studies. We have GMP-compliant stability study and storage facilities, including fully qualified environmental chambers, refrigerators and have continuous monitoring equipment and analytical systems. Our one-stop services for all stability studies encompasses at least multiple aspects of pH, appearance, potency and sterility testing. Contact us to learn more about viral vector stability studies. We will be happy to assist you.
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