Catalent to use GPEx cell line tech to make Amarantus' protein candidate
MANF is a naturally-occurring protein produced by the body to reduce and prevent cell death following injury or disease, and a recombinant form is being investigated by Amarantus for the degenerative eye disease retinitis pigmentosa (RP), though further indications may include may include Alzheimer's disease or traumatic brain injury.
In preparing to take the product into first-in-man trials in 2016, the company has selected contract development and manufacturing organisation (CDMO) Catalent to manufacture all clinical supplies, providing all cell line engineering, process development and clinical Good Manufacturing Practices (cGMP) biomanufacturing activities.
“They have the cGMP capabilities, expertise and proprietary technologies required to efficiently synthesize and scale up MANF production for human clinical use,” Amarantus CEO Gerald Commissiong said.
“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.”
Under the agreement – financial terms of which were not disclosed – Catalent will use its proprietary GPEx mammalian cell-line technology made from its Madison, Wisconsin facility.
According to the CDMO, GPEx offers biotech firms expedited, typically Chinese Hamster Ovary (CHO) cell production, cutting development times down from typically 18 months to under five, as well as producing higher protein expression yields.
Almost 500 different monoclonal antibodies (mAb) and mAb fusions have been expressed using the GPEx platform, as well as over 50 different recombinant proteins.
