Oklahoma City, OK -- Cytovance Biologics, Inc. and Fountain BioPharma, Inc. jointly announce the execution of a Biopharmaceutical Development and Manufacturing collaboration for FB301, a novel monoclonal antibody (mAb) being developed for the treatment of allergy as a lead indication.
Under the scope of this agreement, Cytovance will spearhead the cell line generation, cell culture process optimization, recovery and purification development, cGMP manufacturing as well as technical and regulatory support to facilitate Fountain's clinical program. FB301 will be developed at Cytovance Biologics' state-of-art process development and analytical laboratories as well as manufactured at its 44,000 sq. ft. production facility that was custom-designed for multi-product cGMP manufacturing and meets U.S. and EU regulatory standards.
"Cytovance is excited that Fountain has chosen us to support this innovative treatment for Allergy," said Darren Head, President and Chief Executive Officer of Cytovance Biologics. "Our experienced staff and state-of-the-art facilities are prepared to deliver the highest quality of development and manufacturing services for successful completion of this clinical milestone for FB301."
"We have successfully completed several development and manufacturing service agreements with Asian clients in the past two years and we are actively expanding our services to the Asian Pacific region, led by Dr. Jeffrey Su, our Chief Scientific Officer," added Mr. Head.
"The FB301 antibody is Fountain's flagship product, which represents a new, innovative medicine to treat a vast array of IgE-mediated allergic diseases; FB301 is licensed from Academia Sinica, the internationally renowned and most prestigious research institute in Taiwan," said Dr. Willie Lin, President of Fountain BioPharma, Inc. "We are pleased to collaborate with Cytovance for advancing the development of Fountain's FB301 product, and look forward to a prosperous relationship between the two companies."
About Cytovance® Biologics
Cytovance® Biologics is a biopharmaceutical contract manufacturing company specializing in the production of therapeutic proteins and antibodies from both mammalian cell culture and microbial fermentation. In addition to its cGMP manufacturing services, the company offers process development, cGMP cell banking and support services from its Oklahoma City state-of-the-art facilities. Our customers receive unparalleled services that meet global regulatory standards and facilitate efficient completion of clinical development.
Learn more about Cytovance Biologics at www.cytovance.com.
About Fountain BioPharma, Inc.
Fountain BioPharma, Inc. is a biotechnology company focused on the discovery, development and delivery to patients of novel antibody therapeutics for treatment of cancer, autoimmune disorders and allergic diseases. Fountain has built a fully-integrated set of capabilities in antibody-based product development which supports its innovative pipelines of clinical stage product candidates. Fountain' proprietary research is based on three core technology platforms, which include: (1) healthy and disease-specific fully human antibody libraries; (2) protein-, cell- and tissue-based antibody screening, and (3) top IgE and anti-IgE R&D in the world. The company has multiple research and development collaborations with prestigious research institutes in Taiwan including Academia Sinica, National Health Research Institute and National Taiwan University Hospital.
For more information, visit www.fountainmab.com.