Advertisement Amarantus enters into cGMP manufacturing deal with Catalent Biologics for MANF - Pharmaceutical Business review
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Amarantus enters into cGMP manufacturing deal with Catalent Biologics for MANF

Amarantus BioScience Holdings (AMBS), a biotechnology company focused on developing therapeutic and diagnostic products for neurological disorders and orphan indications, announced that it has entered into a manufacturing agreement with Catalent Pharma Solutions (CTLT), the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, for 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.

"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 & 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 retinitis pigmentosa (RP) for first-in-man studies, expected to start in 2016."

The project will utilize Catalent’s proprietary GPEx(R) 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(R) 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 (RP), 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 (PD), diabetes and ischemic heart disease, among others.

With this announcement, Amarantus is initiating Investigational New Drug enabling (IND-enabling) studies to support a first-in-man clinical study with MANF.

The Company has retained regulatory expertise to identify the fastest path to human proof-of-concept data by evaluating well-respected regulatory pathways available worldwide, and will be working judiciously towards this objective. Amarantus is targeting the initiation of first-in-man clinical studies for MANF in 2016.