Biotechnology company Amarantus BioScience Holdings, Inc. has entered into a manufacturing agreement with Catalent Pharma Solutions for clinical-grade production of MANF (mesencephalic-astrocyte-derived neurotrophic factor).
Under this agreement, which was announced May 14, Catalent will provide all cell line engineering, process development and clinical Good Manufacturing Practices (cGMP) biomanufacturing activities necessary for the rapid development of a high performance cell line expressing MANF protein.
MANF is a naturally occurring protein that reduces and prevents apoptosis (programmed cell death) in response to injury or disease. Amarantus is currently developing MANF for the treatment of certain ocular conditions, including retinitis pigmentosa (RP). The company recently received orphan drug designation for MANF for the treatment of RP in the United States and in Europe.
Potential opportunities also exist for the treatment of other conditions. MANF proteins have demonstrated proof-of-concept in animal pre-clinical models to treat retinal artery occlusion, glaucoma, Parkinson's disease, diabetes and ischemic heart disease, among others.
According to Amarantus, the project will utilize Catalent's proprietary GPEx technology, which creates high-expression, extremely stable cell lines with speed and efficiency.
"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," explained Gerald E. Commissiong, president and CEO 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 RP for first-in-man studies, expected to start in 2016."