Balancing simplicity with complexity in CMC development and manufacturing for a diverse pipeline

mAbs produced in fed-batch mode by CHO cell lines have a low risk profile. Streamlined platform technology and infrastructure allow for rapid CMC development and manufacture. However, the current and future multiple modality pipeline is stretching the classic mAb platform paradigm, necessitating new modular approaches to development and manufacturing. How do we balance complexity with simplicity to meet current market trends and business drivers such as market growth, demand uncertainty, new product classes, cost-of-goods reduction, increased speed, quality and agility, and improved sustainability? In this presentation, we describe our CMC and development approaches, which include the application of advanced processing technologies in engineering biology, high-throughput analytical technologies and integrated continuous biomanufacturing to meet the market and business challenges of a diverse mAb, multi-specific and therapeutic protein pipeline.