ABSTRACT
Manufacturer: Eli Lilly Pharma Fertigung und Distribution GmbH & Co. KG, Teichweg 3, 35396 Giessen, Germany https://www.lilly.com/ (manufacturer is responsible for import and batch release in the European Economic Area) Immunomedics, Inc., 300 American Road, Morris Plains, NJ 07950, https://www.immunomedics.com/ (U.S.)
Marketing: Immunomedics Europe, Haarlemmerstraat 30, 2181 HC Hillegom, Netherlands, https://www.immunomedics.com/ (E.U.) Immunomedics, Inc., 300 American Road, Morris Plains, NJ 07950, https://www.immunomedics.com/ (U.S.)
Manufacturing
Lymphocytes from mice immunized with human CEA were fused with mouse myeloma cells to generate the hybridoma cell line producing the desired monoclonal antibody (known as Immu-4). The hybridoma cells are injected into pristane-primed mice and ascites, containing the monoclonal anti-CEA antibody, is removed 14 to 30 days after injection. The antibody (purified using a combination of two ion exchange and one affinity chromatographic step) is digested with pepsin to produce F(ab’)2 antibody fragments, followed by cysteine reduction to Fab’-SH. Additional purification steps are then undertaken to remove undigested antibody, additional fragments and pepsin. The final product is presented in a lyophilized form consisting mainly of the anti-CEA Fab’-
2 and H-and L-chain fragments and the following
+L− focus-forming assay, reverse
Overview of Therapeutic Properties
Following reconstitution with the radioisotope technetium-99m, CEA-Scan can be administered to patients with histologically proven colon or rectum carcinoma for radioimaging to detect tumor recurrence or metastases. The Fab’ antibody fragment recognizes the CEA, which is a tumor marker for carcinomas. CEA-Scan is used in combination with other diagnostic methods, such as computerized tomography (CT).
