Viral vector development services with scientific excellence
Viral vectors are modified viruses that can deliver genetic material into cells for diagnostic, therapeutic or prophylactic purposes. They are frequently utilized during gene and cell therapy, but also find applications in vaccines, such as the ones approved against COVID-19 and Ebola.
For pharmaceutical applications, a viral vector is required to have – amongst other things – a good safety profile, low toxicity, high infectivity, and in most cases cell type specificity. Frequently used vectors include adenovirus, lentivirus, adeno-associated virus (AAV), vesicular stomatitis virus (VSV), herpes simplex virus (HSV), poliovirus, reovirus, parvovirus and measles virus.
Infectivity and product stability.
The infectivity (i.e., functional titer) of a viral vector is one of its key characteristics that should be maintained over the entire shelf-life of the product. A robust drug product formulation, as well as suitable storage and handling protocols, should ensure the stability of the vector and avoid a titer loss over time.
Our expert scientists are experienced in developing stable and robust viral vector formulations. We assess the infectivity of viral vector preparations by using TCID50 assays, plague forming assays or other cell-based methods up to biosafety level S2. Our analytical portfolio includes methods for the determination of functional, genomic and physical virus titers together with other potential critical parameters that can negatively impact virus infectivity and safety, like aggregation or, for AAVs, the quantification of empty and full capsids.
We take both, liquid and lyophilized formulations into consideration and assess the stability and infectivity of your product under various storage and handling conditions. This ensures your viral vector drug product to be safe and effective until and during application.
Ensuring the integrity of the genetic payload
Viral vectors deliver the genetic material, DNA or RNA, into the target cells. The genetic material is then responsible for the diagnostic, therapeutic or prophylactic effect. Thus, the structural and physicochemical integrity of the genetic payload is also a critical factor for the success of a viral vector drug product. Coriolis offers research, development and analytical services dedicated to nucleic acids.
Specialized services for your viral vector
Coriolis science-driven solutions are based on our deep understanding of the specific challenges of developing a viral vector formulation or drug product. Our expert scientists will devise dedicated study designs tailored to the needs of your vector type, application approach and development phase.
Lentivirus aggregation analysis
Lentiviruses are frequently used as vectors for cell therapy because they achieve a stable genome integration. However, aggregation is a commonly encountered issue during production, storage, and handling of lentivirus formulations. This can negatively impact virus infectivity and safety of the therapy.
Our expert formulation scientists have many years of experience in developing stable preparations for lentiviruses and other viral vectors. By applying our large portfolio of analytical techniques and tailored stress studies, we can comprehensively trouble-shoot the underlying issues of lentivirus aggregation and obtain a robust formulation composition.
Quantifying empty and full AAV capsids
Adeno-associated viruses are one of the most frequently used viral vector systems. One key aspect of AAVs is the quantification of empty and full capsids.
Coriolis develops and applies several analytical methods for this purpose, including analytical ultracentrifugation (AUC), ion-exchange chromatography (IEX), transmission electron microscopy (TEM) and dynamic light scattering in combination with UV analysis (DLS/UV). With our analytical approach, we can reliably quantify empty versus full capsids even at ultra-low vector concentrations and quantify partially filled and aggregated capsids.
Virus titration and infectivity assays
Titer and infectivity are important attributes of a virus preparation, and their analytical characterization is a central part of development, manufacturing, and quality control of gene therapy products.
Our scientists develop and apply tailored TCID50 and plaque forming assays to obtain infectious titers for your virus formulations. Further we provide qPCR to determine the viral genome copies. Above that, we offer a large portfolio of particle characterization techniques to quantify virus particles i.e., obtain physical titers.
Development services for your viral vector
Explore our large portfolio of development services. In a unique collaborative approach, we individually design each study to meet your expectations and the needs of your current development phase. You will benefit from the scientific experience and advise of our expert scientists to achieve your development goals faster and with a higher chance of success.
Analytical services for your viral vector
Choose from a large set of analytical techniques in a variety of categories or get our expert opinion on the most suitable methods for your analytical challenge. We offer standardized analytical methods for many common sample types and perform dedicated method development specific for your analytical challenge and drug product. Explore our analytical portfolio ranging from discovery phase analysis to lot release testing methods.
Our know-how related to viral vectors
Coriolis is a science-driven service provider. We perform internal research projects with academic and industrial partners to develop new technologies and create in-depth knowledge, which directly benefits our client projects. Our internal Unit Science & Technology, hosting PhD candidates and Postdocs, also actively contributes to the scientific community with numerous peer-reviewed publications each year. Explore our latest publications, articles, and webinars.
Other product types
We tailor our services to your specific product type and development phase. In a unique collaborative approach, our expert scientists focus on your scientific question or development milestone and support your drug development program with their many years of experience. Select your product type to learn more about our services.