Facility Will Help Accelerate Early-Stage Clinical Trials of Biologics
TOKYO, Japan I August 15, 2012 I 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.
SOURCE: Eisai
Post Views: 111
Facility Will Help Accelerate Early-Stage Clinical Trials of Biologics
TOKYO, Japan I August 15, 2012 I 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.
SOURCE: Eisai
Post Views: 111
