A Systematic Framework for Data Management and Integration in a Continuous Pharmaceutical Manufacturing Processing Line

Huiyi Cao,Chandrasekhar Kollipara,Adam Fermier,Rohit Ramachandran,Srinivas Mushnoori,Shantenu Jha,Ravendra Singh,Barry Higgins,Douglas Hausner,Marianthi Ierapetritou

doi:10.3390/pr6050053

Abstract

As the pharmaceutical industry seeks more efficient methods for the production of higher value therapeutics, the associated data analysis, data visualization, and predictive modeling require dependable data origination, management, transfer, and integration. As a result, the management and integration of data in a consistent, organized, and reliable manner is a big challenge for the pharmaceutical industry. In this work, an ontological information infrastructure is developed to integrate data within manufacturing plants and analytical laboratories. The ANSI/ISA-88.01 batch control standard has been adapted in this study to deliver a well-defined data structure that will improve the data communication inside the system architecture for continuous processing. All the detailed information of the lab-based experiment and process manufacturing, including equipment, samples and parameters, are documented in the recipe. This recipe model is implemented into a process control system (PCS), data historian, as well as Electronic Laboratory Notebook (ELN) system. Data existing in the recipe can be eventually exported from this system to cloud storage, which could provide a reliable and consistent data source for data visualization, data analysis, or process modeling.

Highlights

The pharmaceutical industry has been dominated by a batch-based manufacturing process
In the face of the enormous amount of data generated from a continuous process, a sophisticated data management system is required for the integration of analytical tools to the control systems, as well as the off-line measurement systems
A data management strategy is proposed for the data integration in both continuous manufacturing processes and the analytical platforms used for raw material characterization

Summary

Introduction

The pharmaceutical industry has been dominated by a batch-based manufacturing process. This traditional method can lead to increased inefficiency and delay in time-to-market of product, as well as the possibility of errors and defects. One of the advantages of continuous pharmaceutical manufacturing process is that it provides the ability to monitor and rectify data/product in real time. It has been considered a data rich manufacturing process. In the face of the enormous amount of data generated from a continuous process, a sophisticated data management system is required for the integration of analytical tools to the control systems, as well as the off-line measurement systems

Objectives

Methods

Results

Conclusion