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GLP Batch Release Testing


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GLP Batch Release Testing with the EAE Model

API samenessfor products used in the treatment of Multiple Sclerosis may be demonstrated by showing equivalence of biological activity in Experimental Allergic Encephalomyelitis (EAE) studies in comparison to Copaxone®.

EAE is a complex condition characterized by the interplay of immunological and neurological mechanisms that mimics key pathological features of Multiple Sclerosis (inflammation, demyelination, axonal loss and gliosis).Several drugs that are used to treat Multiple Sclerosis have been developed, tested and validated using the EAE model.

Our in vivo laboratories offer OECD-GLP MOG-Induced EAE for QC clinical batch release testing. We offer comprehensive clinical scoring of disease severity, in vivo electrophysiology as a biomarker, and GLP certified histopathology services for the analysis of inflammatory tissues.

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Scientific Data

Electrophysiology (EP) unveils motor and sensory phenomenons in Neuroinflammatory Diseases such as MS/EAE. By adding electrophysiology to studies, we are able to detect changes in disease severity when clinical scores aren't sensitive enough to reflect changes, predict what may happen in the motor system prior to clinical scores showing changes, and understand the neuroprotective effects of therapeutics. 

electrophysiology in EAE
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EAE datasheet


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If you are ready to discuss how a partnership can benefit your development program, our scientists are eager to explore the possibilities with you. Like many other pharmaceutical and medical device developers, you can rely on predictive preclinical data.  

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