Increasing Access to the Clinic with a Low Cost, Low Volume Manufacturing Process

As disease targets become increasingly complex, biological drug researchers are relying more heavily on studying diseases and mechanisms in humans. Development organizations are being asked to quickly manufacture safe, high quality clinical trial material to enable FIH studies. At the same time, more candidates are being investigated, which places a higher demand on limited development resources.
To address this challenge, a new mAb development and manufacturing paradigm is proposed that eliminates process development and right-sizes the scale of manufacturing to match initial FIH study needs. Extensive platform knowledge and historical data were used to design the process so that it would be applicable to a broad subset of mAbs. The process relies on a pre-candidate selection screen designed to identify mAbs that are compatible with the proposed process. Proven manufacturing approaches make up the process to ensure quality and safety of the drug product, to minimize regulatory risk and to enable future program development: a clonal CHO cell line, a 12 day production bioreactor, a two column purification process, generic viral inactivation, a single drug product formulation and configuration and a single set of release assays. The resulting process reduces the cost and time to FIH by 50% and 35% respectively.
In this talk, the proposed manufacturing process will be presented alongside the historical data used to develop it. The criteria for including a mAb in the process will be discussed along with how many mAbs are expected to meet the criteria. The quality of the product produced using the new process will be compared to material from a program involving traditional development. The impact of the process on late stage development and product lifecycle will also be considered.