Seattle, WA USA/Copenhagen, Denmark and Shanghai, China, May 14, 2013 – CMC Biologics today announced the execution of an agreement with RuiYi Inc. to develop a cell line for RYI-008, a novel anti-IL-6 monoclonal antibody. CMC Biologics’ proprietary CHEF1® high-productivity expression plasmid will be utilized for the cell line development to optimize cell growth, and consistent, high-level protein expression in a rapid time frame. Specific terms of the agreement were not disclosed.
“We are excited to work with CMC Biologics, a global contract manufacturing organization known for its technical excellence in biopharmaceutical development and cGMP manufacturing,” said Paul Grayson, President and CEO of RuiYi. “The integrated services, including cell line development using the proprietary CHEF1 system, along with CMC’s responsive and collaborative interactive style made CMC Biologics the obvious partner for this important global effort.”
“We are pleased with the opportunity to build a long-term relationship with RuiYi on the development of RYI-008. RYI-008 is an antibody with unprecedented potency and remarkable half-life, creating a significant opportunity to be a best in class product in the rapidly evolving field of IL-6 biology.” said Mark Sawicki, PhD, Global Vice President Business Development of CMC Biologics. “This agreement underscores our strategic focus on biologics development in emerging markets.”
About CMC Biologics
CMC Biologics is a dedicated contract biopharmaceutical manufacturing and development organization with facilities in Copenhagen, Denmark and Seattle, Washington, USA. CMC Biologics specializes in custom services for scale up and cGMP manufacture of protein-based therapeutics for preclinical, clinical trials, and in-market production. The Company’s fully integrated services includes cell line development using its proprietary CHEF1® system, process and formulation development, and comprehensive analytical testing. CMC Biologics has fully segregated microbial fermentation and mammalian cell culture suites and offers stirred tank and perfusion production processes. To learn more, visit www.cmcbiologics.com.
CHEF1® Expression Technology Advantage
The CHEF1 expression system has been used extensively to create clinical production cell lines and has been approved for commercial production. The CHEF1 integrated expression platform accelerates development of cell lines for cGMP production by using robust procedures and reliable raw materials including chemically defined media, adapted CHO cells, and CHEF1 expression plasmids to produce high levels of recombinant protein in rapid timeframes.
RuiYi is focused on the discovery and development of novel biologic therapeutics that meet the medical and commercial needs for China’s patients and healthcare system and that have the potential to be disruptive globally. In addition to RYI-008, RuiYi has a growing pipeline of monoclonal antibodies from internal discovery efforts utilizing series of the Company’s technologies, including the iCAP (intramembranous Conformation Antigen Presenting) system. Targets include a select subset of G protein coupled receptors (GPCR), where specificity in binding is critical but has proven difficult to achieve with small molecule modulators. RuiYi’s executive management team has offices in La Jolla, California, and RuiYi’s discovery efforts and research facility are located in in the Zhangjiang Hi-Tech Park in Pudong, Shanghai, China. For more, visit www.ruiyibio.com.
RYI-008, also known as ARGX-109, is a novel, extremely potent monoclonal antibody that is highly selective to IL-6, a cytokine widely implicated in inflammation and cancer. The antibody was discovered by arGEN-X, Ghent Belgium, utilizing the arGEN-X SIMPLE Antibody™ technology, and exclusively license to RuiYi to develop and commercialize globally.
Stacie D. Byars
CMC Biologics Global Marketing
Jessica Yingling, Ph.D.