The Mouse Embryo Assays are required by regulatory bodies to be performed on any manufactured IVF product that would come in contact with gametes or embryos prior to lot release.
Embryotech offers the MEA used for toxicity and functionality testing. Test results may be used for lot release or can be submitted to regulatory bodies for premarket submissions.
Aside from the standard MEA, Embryotech also offers Growth and Development Detail, Cell Staining and Cell Counting, Mouse Invitro Fertilization (IVF) and Embryo Transfers.
We can customize any of our standard assays to fit your needs and are here to offer any advice on test methods and requirements.
We would love to hear from you, so please call us for more detailed information regarding the mouse embryo testing we offer.
Fresh or frozen 1-Cell, 2-Cell, 8-Cell, morula or blastocyst embryos from a cross between our most commonly used test uses a minimum of 21 embryos per test and 21 control embryos.
Traditionally an assessment of embryos at 72, 96 or 120 hours; minimum of 80% blastocyst for 1-Cell and 80% for 2-Cell development required for passing the test.
Testing receipt 7 days a week; testing typically completed within 7 days maximum.
Most of the protocols consist of exposing test article to embryos through wash or long-term culture. Raw materials, Disposables, labware or devices are typically flushed with media prior to setting up culture drops for long-term culture.
We have the ability to customize our protocols with your desired adjustments for individual testing that can ensemble your specific quality control requirements.
We recognize that variations to our “standard assay” may be necessary to accommodate your specific QC needs. We welcome and encourage input to customize an assay more suitable for your product. Some examples of common changes to the “standard assay” are as follows: mouse strain, stage of the embryo, size of micro-drop, use of oil in the assay and the extraction time of similar test items.
AN MEA SAMPLE SUBMISSION FORM (CS/TSG/089) MUST BE COMPLETED IN FULL AND ACCOMPANY THE SAMPLE(S) SENT FOR TESTING.