Presented at Bio-IT World, Boston, MA, USA
The development process for large-molecule therapeutics is a complex task. Biopharmaceutical drugs are made of large, complicated, and fragile biomolecules that are produced in highly complex manufacturing processes. Novel therapeutic classes such as bi- and multi-specific antibodies, ADCs, and novel scaffolds pose additional challenges in expression, purification, analytics, and formulation development. Here, we present a new workflow platform for large-molecule development and CMC, which has been designed to make biopharma development operations more efficient and improve overall process quality. The end-to-end platform streamlines complex workflows in cell line development, upstream and downstream process development (USP and DSP), drug formulation, and analytical development. Designed to support high-throughput processes, it can handle huge data volumes. The platform structures the vast amount of analytical data and process information generated during bioprocess development, and tracks the quality of the produced materials (e.g., CQAs). Concrete use cases illustrate how the platform, as an open system, directly interfaces with laboratory instruments such as bioreactors (e.g., Ambr) and analytics instruments, as well as corporate IT infrastructures. The system enables biopharmaceutical, biotechnology, and contract manufacturing organizations, to more efficiently develop and manufacture novel protein-based therapeutics and biosimilars.