Immunotherapy is an evolving and promising cancer treatment that works by stimulating the immune system. Historically, scientists routinely use immortalized cell lines in the research and development of therapies as they offer an inexpensive and stable platform. However, they are not fully representative of what is going on in vivo. For this reason, more biologically relevant human primary cells are now the chosen starting material for immunotherapy development.
The increasing success of immunotherapies is driving a need for high-quality leukapheresis-derived cellular starting material which is essential in drug development. At Excellos, we understand that it’s not enough to just have access to a large and diverse donor pool, with the ability to recall donors. It’s the technical expertise of the apheresis staff and scientists with decades of experience that ensure collections are processed correctly to preserve cell quality.
Our apheresis operators and scientists are trained to understand and minimize where possible the donor and collection process variation that can occur. For example, the same apheresis operator will work on the same machine for the same donor to reduce any collection variation. However, some variations can be harder to eliminate. Due to circadian rhythms, the time of day the collection is performed can impact the cellular composition from the donor. Even what the donor ate or drank can affect collection. Different donors, different ages, different genders, all with different lifestyles, contribute enormously to the high variation seen in donor collections. Fortunately, at Excellos, our data-driven donor characterization and integration system takes donor annotation to the next level. This helps us better predict which donors will best match your immunotherapy development process.
At the cellular level, we understand that the starting material for immunotherapies is also inherently heterogeneous. Even the purest population of a given type of cells will contain subpopulations of cells. It is essential to reduce process-related variability, including cell collection, handling, and storage. Our cryopreservation specialists work hard with cell-specific protocol optimization to ensure post-thaw viability of cellular starting material remain high. This is critical if you expect the cells to perform in your assays. As a CDMO, we also have the ability to analyze, run assays, and provide contract services to further reduce the variability by in collections and cellular processing.
High-quality cellular material is critical in the development of immunotherapies as it contributes to the quality of your data downstream. To support your immunotherapy program, Excellos provides the following:
With our scientific expertise and extensive functional characterization and annotation platform we can help you to select the best donor for the development of your immunotherapy.
All leukapheresis products are obtained by apheresis of normal donors in our FDA-registered donor center. All donors (collected under IRB-approved consent) undergo testing for infectious diseases with common blood-borne pathogens and viruses including RPR, HIV, LCMV, and HVC. Excellos donors are also extensively characterized (functionally, phenotypically and metabolically). Apheresis collections from healthy donors are purified, isolated and cryopreserved under stringent guidelines.
Excellos Quality Control – To ensure viability and cell counts of our cellular products, we implement random sampling per lot. A Certificate of Analysis (CoA) is included with every shipment. Characterization by immunophenotyping can also be performed upon request and included in the CoA.