MS/EAE Disease Modeling
In Draft Guidance On Glatiramer Acetate that was published in April 2016, the FDA listed several criteria for demonstrating API sameness. Of those criteria, equivalence of biological assay results ,such as Experimental Allergic Encephalomyelitis (EAE) studies, remains of great interest, as this is in effect a critical downstream readout of whether the end product is efficacious (provided similar safety testing results to the RLD Copaxone®).
EAE is an intricate condition in which the interaction between a variety of immuno-pathological and neuropathological mechanisms leads to an approximation of the key pathological features of Multiple Sclerosis (MS): inflammation, demyelination, axonal loss and gliosis. The counter-regulatory mechanisms of resolution of inflammation and re-myelination also occur in EAE, which therefore also serve as a model for these processes. Many of the drugs that are in current or imminent use in MS have been developed, tested or validated on the basis of EAE studies.
MD Biosciences in-house in vivo laboratories offers OECD-GLP MOG-Induced EAE model for QC Clinical Batch Release testing of GMP processes. Furthermore, we offer services for comprehensive clinical scoring of disease manifestations as well as multiple behavioral assessments associated with inflammatory diseases of the CNS and GLP-certified histopathology laboratory services for qualitative and quantitative histologic analysis of neuroinflammatory tissues.
For Batch Release Testing, contact us.