The FDA’s Quality by Design (QbD) initiative, part of the larger Process Analytical Technology (PAT) effort, will require an enormous undertaking by companies that plan to employ its principles. The goal of QbD is for companies to consistently and quickly produce high-quality products by demonstrating a deep scientific understanding of their own manufacturing processes.
A manufacturing philosophy like this would greatly reduce the need for heavy regulatory oversight. To get ta point where the benefits of such a systemic overhaul would prove beneficial, however, many companies must spend years documenting and gathering validated processes.
The ideal QbD set-up for manufacturing biopharmaceuticals is a sophisticated, complicated affair. Every component must work to facilitate automation in one way or another. The first major piece in a system with automated cell culture analysis should be a bioreactor with a manufacturing execution system (MES) or laboratory information management system (LIMS) that can automatically adjust processes based on the measurement data of critical process parameters.
The culturing vessel can either be a steel tank, a glass vessel, or a single-use bag. All along the way, in-line sensors of all types are set up to measure pH, pressure, temperature, and CO2, to name a few factors. A key enabling product is Bayer Technology Services’ new sterile online sampling unit, which automatically removes samples from a bioreactor and transfers them to a liquid-management unit.