XOMA Establishes Development and Manufacturing Relationship with Taligen
Wednesday May 17, 9:00 am ET
XOMA to utilize its Bacterial Cell Expression Technology to Manufacture Novel Anti-Inflammatory Therapeutic for Clinical Trials
BERKELEY, Calif.--(BUSINESS WIRE)--May 17, 2006--XOMA Ltd. (Nasdaq:XOMA - News) today announced the completion of a letter agreement with Taligen Therapeutics, Inc. of Aurora, CO for the development and cGMP manufacture of a novel antibody fragment for the potential treatment of inflammatory diseases.
The agreement calls for XOMA to utilize its Bacterial Cell Expression technology and expertise to develop and scale-up production processes for Taligen's FAb antibody fragment. XOMA will also manufacture quantities of the antibody fragment sufficient to support preclinical and initial clinical trials. XOMA intends to commence work on the project immediately and to negotiate a longer-term definitive agreement with Taligen later this year.
"XOMA has substantial expertise in bacterial cell line development, process development, scale-up and manufacturing ideally suited to biologics, and we are pleased that Taligen can benefit from XOMA's capabilities on such an important product for Taligen," said Woodruff Emlen, M.D., President of Taligen.
"We are pleased to help Taligen develop and manufacture this antibody fragment," said Rob Tenerowicz, XOMA's vice president of operations. "Our agreement with Taligen is especially important because it demonstrates the breadth of our capabilities and expertise in bacterial fermentation processes in addition to our better-known strengths in mammalian cell culture systems. It also supports XOMA's business strategy of leveraging our cell line and process development expertise, along with our production capacity, to generate revenue."
XOMA's development and manufacturing capabilities
With more than 20 years of experience developing therapeutic proteins, especially antibodies, XOMA has built a fully integrated infrastructure that supports biologics development from recombinant DNA engineering and cell expression, through production scale up and cGMP manufacturing. XOMA can rapidly create a production process and advance antibodies into pilot scale production, then complete process scale-up and produce GMP material for use in human clinical trials, Biologics License Applications (BLA) filings, and for initial commercial launch. XOMA's process development and manufacturing capabilities include:
Cell line and process development
Optimization of production processes, including scale-up
Analytical assays and test methods
Formulation optimization
Pilot Plant for process development and scale-up with two 500L fermenters
cGMP manufacturing facility with three production trains of 2750L capacity
Full service Quality infrastructure (Quality Assurance, Quality Control, Quality Engineering)
Filling capability up to 3,000 vials (including labeling and packaging services) sufficient for clinical trials
Stability program, including all stability-indicating assays
For more information about XOMA's process development and manufacturing capabilities, please visit xoma.com
About Taligen
Taligen Therapeutics is a biotechnology company focused on the treatment of complement-mediated inflammatory diseases through modulation of complement activation. |
