FDA Approves Immunomedics' New Manufacturing Facility And Processes
The U.S. Food and Drug Administration has approved a new manufacturing facility and processes for Immunomedics' (Morris Plains, NJ) CEA-Scan, an antibody-based diagnostic product formerly produced at the company's Newark, NJ manufacturing plant.
The FDA's audit of the new Morris Plains facility included a review of changes in product manufacturing processes for both CEA-Scan (arcitumomab) and LeukoScan (sulesomab). "One of our strengths is our ability to manufacture our clinical and commercial products in sufficient quantities, at acceptable costs," said Robert DeLuccia, president and CEO of Immunomedics. "CEA-Scan, marketed in the U.S. and Europe, is directly affected, and the facility approval will impact other marketed products and potential new products, including LeukoScan, in our development pipeline."
The new manufacturing facility consists of four independent manufacturing suites permitting the simultaneous production of four different products. Clinical trial products, including the Company's therapeutic products, are manufactured in the same suites sequentially. The facility and process changes were approved by the European Committee for Proprietary Medicinal Products (CPMP) in May 1998 for CEA-Scan and LeukoScan, both of which are marketed in Europe. LeukoScan is presently under regulatory review by the FDA for marketing approval in the U.S.
Colorectal cancer diagnostic CEA-Scan, Immunomedics' first product, is marketed in the United States and Europe. The company's second diagnostic imaging product, LeukoScan, marketed in Europe for diagnosing osteomyelitis (bone infection), is under regulatory review by the FDA.
CEA-Scan consists of a monoclonal antibody fragment conjugated with technetium 99m, the most used radioisotope in medicine today. CEA-Scan targets carcinoembryonic antigen (CEA), which is present in many forms of cancer. Similarly, LeukoScan is an antibody fragment-technetium conjugate targeting the CD22 antigen.
For more information: Immunomedics, 300 American Rd., Morris Plains, NJ 07950, USA. Telephone: 973-605-8200. Fax: 973- 605-8282.