The Absolute Essentials Of Manufacturability: Ensuring Process Continuity From Research To Commercialization

By Maik W. Jornitz, principal consultant, BioProcess Resources LLC

The shift toward breakthrough modalities like mRNA vaccines, gene therapies, and lipid nanoparticles (LNPs) has intensified a critical challenge: manufacturability. Manufacturability is the inherent capability of a process to produce a consistent, high-quality product that scales efficiently from research to commercial production. It must be embedded at the research stage, not as a downstream engineering fix.

Ignoring manufacturability early on leads to significant consequences, including costly process redesigns, regulatory delays, and increased expenses. Regulatory bodies globally expect developers to demonstrate deep process understanding and scalability, with the era of "develop now, fix later" rapidly fading. Core to manufacturability is selecting equipment that ensures linear scalability of critical parameters, such as mixing dynamics, across all volumes. Furthermore, integrating Quality by Design (QbD) and Process Analytical Technology (PAT) is crucial for robust process control and reducing development time. Learn how to build a culture of manufacturability and streamline your product's journey from benchtop to market by accessing the full article.