Mixed Lymphocyte Reactions – GLP vs. non-GLP Regulatory Compliance

 While many of our clients use Mixed Lymphocyte Reactions (MLR’s) to evaluate the potential for graft rejection early in the development of their technology, other clients use the Mixed Lymphocyte Reaction as part of the preclinical regulatory submission package. Due to this need, Xeno Diagnostics is uniquely set up to perform Mixed Lymphocyte Reactions under Good Laboratory Practices (GLP’s). While this does require additional effort from both Xeno and our clients, this ensures that the data obtained from these studies meets regulatory expectations. We advise clients who require this level of compliance to leave enough space in their timeline to perform the necessary pilot studies for the validation of the assay, specific to their implantable medical device or technology.

  Whether your Mixed Lymphocyte Reaction requires GLP compliance, or can simply be run under research protocol, we encourage you to contact us with your questions. Simply fill out the form below, or give us a call at (317) 973-4079.