Biological Drug Intelligent Manufacturing Platform

Background:

Batch control system can realize complex recipe management in the laboratory experiment process, which is mainly used to realize fully integrated automatic production control based on master/control recipe, realize the goal of small-batch multi-variety flexible production, and complete the data tracing and audit tracking functions. The mechanism data model can help experimentalists predict and optimize the recipe parameters and experimental steps, and help experimentalists quickly find the right recipe and effectively shorten the experiment time. However, the current operations from data model to batch control and finally to experimental equipment are all by manual, how to connect IT and OT is a huge challenge.

Solution:

Utilizing AUSTAR's own batch management system - RecipePro, which is designed and developed in accordance with the S88 (ISA-88) standard. RecipePro integrates a cloud-deployable, web-based recipe management platform with a local batch control model powered by Siemens S7-1500 PLC workflow engines. The primary objectives are to enable flexible production of small batches with multiple varieties, achieve flexible automation control based on recipes, ensure compliance with pharmaceutical data integrity requirements, and generate electronic batch records compliant with FDA 21 CFR Part 11.

The intelligent manufacturing system's recipe parameters are derived from calculations and optimizations performed by ZheJiang University's cloud-based mechanistic data models. The model's computed results are downloaded to RecipePro, which then controls the production execution process on Cytiva chromatography equipment. Upon completion, RecipePro collects process data, batch data, quality data and alarm information and transformed to a kind of structured format to store to SQL Server. The feedbacks would be given to mechanistic data models for analysis, facilitating self-optimization and iteration of the models.   

Contribution and Customer Benefits:

Bridging the gap between model calculations and automation equipment, deeply integrating intelligence into manufacturing, automating the entire process from model calculations to production execution.

The mechanistic models receive data from RecipePro to optimize their algorithms, while RecipePro obtains recipes from model calculations to automatically control chromatography equipment. This symbiotic relationship ensures continuous improvement and optimization of the entire production process.