Allogeneic Cell Therapy
Allogeneic therapies use cells from healthy donors that are expanded and may be modified before they are used to treat patients. In addition to human donor screening, additional GMP biosafety testing must be performed after the GMP cell-processing activities have been completed.
Why Choose Eurofins BioPharma Product Testing network?
- In addition to the final Certificate of Analysis, we also provide raw data results as a deliverable.
- Our industry leading online data portal, LabAccess, provides customers access to our LIMS system, allowing 24-hour access to data.
- Our dedicated Project Management team focuses on biosafety, rapid testing, and client communications to assure on time delivery in a GMP environment.
- Our PhD scientists and Quality Assurance teams work together to provide expertise that ensures sound scientific approaches and GMP adherence.
Testing Performed
GMP biosafety testing, such as sterility, mycoplasma, in vitro adventitious agent, etc. should be considered to confirm the product has not been contaminated.
A critical item to consider are the raw material inputs. If the human cells are exposed to any reagents or materials derived from animals, targeted species-specific viral testing may be needed. Manufacturing may utilize retroviruses which means that downstream virology testing may also be required If viral vectors are used for gene editing, replication competent testing may be needed.
Sample Considerations
Sample harvest for these individual test methods may vary during the cellular processing and can vary based upon your cellular processing approach. Appropriate sample planning and assessment of the manufacturing process should be considered to determine the most appropriate time to take a sample for a particular biosafety test method. Sampling plans and GMP release testing should always be discussed with your regulatory reviewer to be sure the approach is satisfactory and will yield the most accurate information prior to administering the cellular product to a patient. If appropriate, Eurofins can provide cell expansion to generate enough material to run the various GMP release test methods.
