Original developers of biosolutions and products, especially those facing the debut of biosimilars in core markets, have an urgent imperative to reduce manufacturing costs through increased productivity and yields. In turn, this drives a wide range of business decisions, including capital investment, process choices and design, and equipment selection. To this end, biodevelopers are adopting more sophisticated processes (such as perfusion) to address low-titer cell lines and reduce raw material costs. They’re also seeking more sophisticated and flexible R&D and process development capabilities in several ways by using equipment to enable simultaneous development of multiple products, automate rapid experimental design and implementation, optimize processes, and gain better analytical insights — especially for process analytical technology (PAT) and regulatory compliance.
Introducing AlphMab, a Fully Equipped Biodeveloper and Producer
AlphaMab Co. Ltd. is a fast-growing biodeveloper and producer with those kinds of capabilities. Founded in 2009 and located in Suzhou (a city about 60 miles northwest of Shanghai, China), AlphaMab’s R&D center consists of more than 60,000 ft2 of offices and laboratories, fully equipped for investigating, commercializing, and producing the latest biologic products. Its BDS and FFP suites are built to meet the rigorous current good manufacturing (CGMP) requirements of the CFDA, FDA, and EMA. After those facilities opened in 2013, the Jiangsu CFDA certified them for biologics manufacturing. Facilities also include a pilot plant, GMP production site, and a fill–finish plant.
Login to read the full PDF of the application note.