- For Print
- August 15, 2012
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that its U.S. subsidiary Morphotek®, Inc. (Headquarters: Pennsylvania, President & CEO: Nicholas Nicolaides, Ph.D., “Morphotek”) celebrated the grand opening of a new pilot manufacturing plant for the production of antibodies to support its early-stage clinical trials on August 14, 2012 (U.S. Eastern Standard Time).
Constructed with an investment of U.S.$80 million on a site located next to Morphotek’s current headquarters in Exton, Pennsylvania, the new 60,000-square foot (approximately 5,574-square meters) facility encompasses a pilot plant designed according to current Good Manufacturing Practice (cGMP) regulations enforced by the U.S. Food and Drug Administration (FDA), labs to support cell line optimization and product characterization, labs for quality assurance/quality control, and office space for support functions, amongst other facilities. Although Morphotek has outsourced the manufacture of antibodies to support clinical trials up until now, the establishment of the new facility will enable the company to undertake antibody production in-house. The plant has been designed to enable Morphotek to undertake the manufacture multiple investigational antibodies simultaneously, thereby accelerating early-stage clinical research of novel therapeutic antibodies being undertaken by Eisai group and maximizing efficiencies in the product creation process. The new facility is scheduled to commence production operations before the end of 2012, and following process validation, will begin to manufacture antibodies for use in clinical trials during the first half of fiscal 2013.
Morphotek specializes in the research and development of therapeutic antibodies primarily for the treatment of cancer through the use of its proprietary human antibody production technology and active engagement in partnership-based collaborative research. The company currently has a number of promising monoclonal antibodies in clinical development, including farletuzumab (MORAb-003), in Phase III development for platinum-sensitive ovarian cancer and Phase II development for non-small cell lung cancer, MORAb-004, in Phase II development for melanoma, colorectal cancer and sarcoma, and MORAb-009, in Phase II development for mesothelioma.
Eisai is committed to undertaking product creation activities aimed at the development of innovative small molecules and biologics such as antibodies. With the establishment of the new pilot manufacturing plant, Eisai will acquire the ability to manufacture biologics in-house, thereby shortening therapeutic antibody development times even further and ensuring the early delivery of treatments that satisfy the unmet medical needs of patients and their families.
[ Please refer to the following notes for a photograph of the pilot plant and the plant opening ceremony ]
Public Relations Department,
Eisai Co., Ltd.
< Notes to editors >
1. Photograph of New Pilot Manufacturing Plant
2. Photograph of Plant Opening Ceremony
Pictured left to right are Christopher Molineaux, President, Pennsylvania Bio; Hideki Hayashi, Deputy President and Chief Product Creation Officer, Eisai Co., Ltd.; Nicholas Nicolaides, President and CEO, Morphotek, Inc.; Haruo Naito, President and CEO, Eisai Co., Ltd.; Philip Sass, Executive Vice President and COO, Morphotek, Inc.; Joye Bramble, Vice President, Pilot Plant Operations, Morphotek, Inc.; Pennsylvania State Senator Andy Dinniman; Eli Avila, Pennsylvania Secretary of Health, and Luigi Grasso, Chief Scientific Officer, Morphotek, Inc.