Amarantus BioScience Holdings, Inc., a biotechnology company focused on developing therapeutic and diagnostic products for neurological disorders and orphan indications, has entered into a manufacturing agreement with Catalent Pharma Solutions for the clinical-grade production of MANF (mesencephalic-astrocyte-derived neurotrophic factor). Under the agreement, 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 that will thereafter be advanced into scale up for cGMP production.

The project will use Catalent’s proprietary GPEx technology, which creates high-expression, extremely stable cell lines with speed and efficiency, typically capable of getting drug development projects to clinic in one-third the time of traditional approaches. The advantages of applying GPEx technology span 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, and recently received orphan drug designation for MANF for the treatment of RP in the United States and in Europe. In addition, MANF proteins have demonstrated proof-of-concept in animal pre-clinical models to treat a wide range of conditions including retinal artery occlusion, glaucoma, Parkinson’s disease, diabetes and ischemic heart disease, among others.

Source: Amarantus BioScience