MediPost will enter the contract development and manufacturing organization (CDMO) business for human induced pluripotent stem cell (hiPSC)-based dermal papilla cell culture medium.
MediPost said Aug. 18 that it signed a CDMO agreement with Qstem for hiPSC-based dermal papilla cell culture medium.
Under the agreement, MediPost will use its good manufacturing practice (GMP)-level production and quality control capabilities to establish Qstem’s production system for dermal papilla cell culture medium and handle the supply of raw materials.
Qstem’s dermal papilla cell culture medium is produced through a process that takes about 120 days, during which hiPSCs are differentiated into and cultured as dermal papilla cells. MediPost plans to apply its manufacturing process scale-up technology to establish a mass-production system and reduce quality variations between batches.
The produced culture medium will undergo quality testing for appearance, sterility, mycoplasma, adventitious viruses, identity and purity in accordance with safety standards for human cell and tissue culture media before shipment.
MediPost plans to use the agreement as an opportunity to expand its CDMO business based on its accumulated production and quality control capabilities from cell therapy manufacturing.
A MediPost official said, “We are supporting the commercialization of Qstem’s dermal papilla cell culture medium based on our accumulated stem cell manufacturing technology and GMP quality control capabilities,” adding, “We will strengthen our global CDMO competitiveness through the stable mass production and supply of high-quality cell culture media.”
Meanwhile, MediPost recorded $27.5 million in standalone revenue and $467,000 in operating profit in the first half of this year.
On a consolidated basis, revenue totaled $25.5 million, while the company posted an operating loss of $27.5 million. The loss reflected research and development and clinical costs related to entering the U.S. and Japanese markets.
MediPost is pursuing the global commercialization of Cartistem as a key growth driver. The company met both primary and secondary endpoints in a Phase 3 clinical trial in Japan during the second quarter and plans to file for Japanese marketing approval by the end of this year.