Downstream PAT Using Raman Spectroscopy

Comprehensive strategy for sharing and collaborating on Process Analytical Technology (PAT) models within the NIIMBL community

Industry Need

This project directly addresses the substantial time and cost associated with traditional biopharmaceutical product quality determination and release, which can currently take 6-12 months and represent a significant portion of manufacturing expenses. By developing and demonstrating the utility of Raman-based Process Analytical Technology (PAT), this initiative will enable real-time, in-line monitoring and control of Critical Material Attributes (CMAs), Critical Process Parameters (CPPs), and Critical Quality Attributes (CQAs) within GMP processes. This shift will significantly reduce product release times and manufacturing costs, moving the industry closer to the long-standing regulatory goal of real-time process and product control. Ultimately, the project's success in establishing a validatable Raman PAT technology, exemplified by its application to NIST-mAb purification and supported by industry use cases, will revolutionize biopharmaceutical manufacturing by enhancing efficiency, ensuring consistent product quality, and accelerating market access for high-demand products.

Approach

This initiative proposes to address this challenge by exposing Boehringer Ingelheim's (BI) non-proprietary PAT methodology and associated data to the broader NIIMBL community. By providing a deep and open description of previously unshared data and methods, we aim to foster robust community discussion, feedback, and audit from multiple industry members rather than relying on a single organization. This collaborative approach will enable the NIIMBL community to potentially adopt, refine, and advance this method, ultimately leading to its widespread implementation and establishing it as a recognized industry standard for downstream PAT. This will require the active participation of multiple members to truly advance the technology.

Impacts

Informational Advantage: Gain real-time, live understanding and control over experiments, enabling instantaneous process adjustments and deeper insights into development.

Accelerated Optimization: Establish process optimizations and control strategies with unprecedented speed, using the same experiments to define and refine each step.

Community-Driven Innovation: This project fosters a collaborative environment where reviewers and other community members actively participate in evaluating the method. Their feedback, intentions, and insights will be captured and directly applied, ensuring the method's refinement reflects a broad industry consensus. This collective input ensures that the advancement of PAT is not "siloed" to one organization but serves the diverse needs of multiple industry members.

Avoidance of Costly Batch Failures: Directly prevent batch failures, translating into multi-million-dollar savings and increased manufacturing reliability.