Discover Accelerated Approaches For Successful Commercial Filing

By Jonas Müller, Ph.D., Head of Upstream Development, Microbial

Microbial expression supports the production of a diverse range of molecules, including enzymes, antibody fragments, plasmid DNA, and conjugated vaccines. Given this diversity, there is no single chemistry, manufacturing, and controls (CMC) pathway that suits every program. Following a conventional sequential approach, from launch-scale technology transfer through preparation of a submission-ready dossier, can take three to four years. Running selected late-stage activities in parallel can shorten the development timeline, but introduces additional risks that must be carefully managed.

This paper presents a five-step planning methodology to help teams evaluate serial and parallel approaches and determine where acceleration is feasible. The framework is applied to three real-world programs, highlighting opportunities to save time through risk assessment, scale-down model qualification, and adjustments to process characterization scope. Each case study also examines the practical requirements of accelerating development, including the need for extensive process experience and compensating measures when data are limited. One example illustrates the value of investing earlier in development activities to reduce delays and effort later in the process. By examining both the potential efficiencies and the associated trade-offs, the paper offers a practical perspective on building a more efficient CMC strategy.

Explore the case studies to identify where parallel execution may offer meaningful time savings and what it takes to manage the added risk.