Amarantus, Catalent Ink cGMP Mfg. Pact

Amarantus BioScience has entered a manufacturing agreement with Catalent Pharma Solutions for clinical-grade production of MANF (mesencephalic-astrocyte-derived neurotrophic factor). Catalent will provide all cell line engineering, process development and cGMP biomanufacturing activities for the development of a high performance cell line expressing MANF protein that will then be advanced into scale up for cGMP production.
 
Catalent will use its GPEx technology, designed to create high-expression, stable cell lines quickly and efficiently. Applying GPEx technology spans from early feasibility studies to clinical manufacturing and commercial scale production.
 
MANF is a naturally-occurring protein that reduces and prevents apoptosis (programmed cell death) in response to injury or disease. Amarantus is developing MANF for the treatment of orphan ocular indications, including retinitis pigmentosa (RP), and recently received orphan drug designation for RP in the U.S. and Europe. In preclinical models MANF proteins have also demonstrated potential to treat a wide range of conditions including retinal artery occlusion, glaucoma, Parkinson’s disease, diabetes and ischemic heart disease, among others.
 
“We selected Catalent as our development and manufacturing partner because they have the cGMP capabilities, expertise and proprietary technologies required to efficiently synthesize and scale up MANF production for human clinical use,” said Gerald E. Commissiong, president and chief executive officer of Amarantus. “Advancing MANF, our first internally-discovered therapeutic product candidate, into human clinical studies will be a major advancement for the Company. Rapid production of MANF in collaboration with Catalent will enable us to achieve this objective as quickly and in the most cost-effective manner possible. The Company is currently targeting the orphan ocular indication retinitis pigmentosa (RP) for first-in-man studies, expected to start in 2016.”