Accelerating Attribute-Focused Process and Product Development Through
the Development and Deployment of Autonomous Process Analytical
Technology Platform System
Abstract
Enabling real-time monitoring and control of the biomanufacturing
processes through product quality insights continues to be an area of
focus in the biopharmaceutical industry. The goal is to manufacture
products with the desired quality attributes. To realize this rigorous
attribute-focused Quality by Design (QbD) approach, it’s critical to
support the development of processes that consistently deliver
high-quality products and facilitate product commercialization. Time
delays associated with off-line analytical testing can limit the speed
of process development. Thus, developing and deploying analytical
technology is necessary to accelerate process development. In this
study, we have developed the Micro Sequential Injection (µSI) process
analyzer and the Automatic Assay Preparation Platform (A2P2) system.
These innovations address the unmet need for an automatic, online,
real-time sample acquisition and preparation platform system for
in-process monitoring, control, and release of biopharmaceuticals. These
systems can also be deployed in laboratory areas as an off-line
analytical system and on the manufacturing floor to enable rapid testing
and release of products manufactured in a GMP environment.