Cell therapy product
We support the development of CAR-T and other cell therapies with science-driven services
Cell therapy is an innovative approach which makes therapeutic use of cells to fight a range of diseases including cancer, autoimmune and degenerative disorders.
Chimeric antigen receptor (CAR) T is one prominent type of cell therapy which is already a well-established treatment option for millions of cancer patients. But many more platforms of promising cell therapies (e.g., T cell receptor (TCR) and natural killer (NK) T cells therapies) with the potential to address many currently unmet medical needs are in various phases of development.
In the most common approach, autologous or allogenic cells are genetically modified ex vivo by using a viral vector carrying the genetic material. The cells are subsequently administered to the patients to elicit their therapeutic effect. Lentiviruses and retroviruses are the most frequently used vectors, as they are capable of a stable gene integration.
Cell therapy approaches are highly complex
A cell therapy treatment includes many steps, which are – in case of autologous cell therapy – even performed individually for each patient. These steps include the extraction of the starting cell material, the genetic modification, the manufacturing of the cell preparation, the quality control, the administration to the patient, as well as the transport and storage in between those steps. Cell therapies thereby utilize nucleic acids encoding the genetic material, viral vectors carrying and integrating the genetic material, and – of course – the cell cultures.
Coriolis supports the development of cell therapy products and procedures with a variety of services. We offer the development of stable nucleic acid formulations and their analytical characterization (read more here). Our expert scientists also assess the infectivity of viral vector drug products and obtain stable vector formulations (read more here). Above that, we develop particle characterization methods for quality control and release testing of cell based medicinal products. Our formulation scientists also develop robust liquid, frozen-liquid as well as lyophilized cell preparations suitable for sort and long-term storage. We assess stability of your product against freeze-thaw, light exposure or mechanical stress.
Specialized services for your cell therapy product
Coriolis science-driven solutions are based on our deep understanding of the specific challenges of developing a cell therapy product. Our expert scientists will devise dedicated study designs tailored to the needs of your product, application approach and development phase.
Cell viability and size distribution analysis
Viability and the size distribution of the cells are important parameters of a cell culture. Handling, storage, and freeze-thaw procedures may negatively affect the cells and thereby the effectivity or safety of the therapy.
Coriolis performs tailored stress studies including photostability, freeze-thaw and mechanical stress and characterizes the critical product parameters such as cell viability and cell size distribution, but also the presence of cell debris, morphologically altered cells or particulate impurities, such as dyna beads originating from cell activation step.
Development of viral vector drug products
Viral vectors based on lentiviruses or retroviruses are the most common gene delivery system used for cell therapy. The development of a stable and effective viral vector drug product for cell therapy is a challenge on its own. A high infectivity, effective gene integration and low toxicity is desired. Also, the vector shall maintain its properties during the intended shelf-life until application.
Coriolis offers research, development, and analytical services dedicated to viral vectors.
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 cell therapy product
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 cell therapy product
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 cell therapies
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.