Characterized Starting Materials
Donor attributes including age, BMI, race, gender, health history, and viral testing per 21 CFR 1271 regulations along with HLA typing and KIR profiling are compiled for GMP eligible donors. We also perform a 9-color flow panel immunophenotyping analysis on the cryopreserved MNCs to provide additional characterization data on different immune cell subsets.
Optimized Donor Selection
Our dedicated team helps clients utilize the donor characterization datasets to select the most suitable donors with the attributes that align with their program-specific requirements, and coordinate scheduling of these donors for GMP collections of fresh or cryopreserved leukopak products. This high-resolution data also provides valuable insights about how starting material attributes influence the final CGT product, which helps researchers develop more robust and controlled manufacturing processes to ensure consistency and quality throughout the entire production workflow.
AllCells’ streamlined approach significantly reduces the timeline compared to conventional workflows, where it is necessary to recall donors for whole blood screening and characterization, prolonging the donor selection process.
Custom Whole Blood Screening Options
For clients seeking donors with specific attributes not covered by the program, we also offer custom pre-screening solutions via whole blood. Whether it’s specific genetic markers, phenotypic characteristics, or other desired attributes, our team works closely with clients to understand their unique screening requirements. With our flexible and customizable approach, we enable clients to access the donors they need to advance their programs with confidence.