< Back to previous page

Publication

Full Scale Product Lifecycle management in biotech production using advanced control and production information systems: Shorten New Product Development and Introductions in Bio-pharmaceutical industries using ISA-88 and ISA-95

Book Contribution - Book Chapter Conference Contribution

Starting from an example of the production of a therapeutic monoclonal antibody using animal cell culture (MAb) using simulation and scheduling software for optimizing and de-bottlenecking the production processes, we abstract from the P&ID and model the control software for a Biotech Plant using an ISA standard ISA-88 and connect it with the Business Information Systems and Enterprise Resource Planning (ERP) software using the ISA standard ISA-95 (the international standard for developing an automated interface between enterprise and control systems) and XML-schemas BatchML and B2MML respectively. The ISA-88 standard together with BatchML helps in making the abstraction of the physical design towards a development of a software configuration. It enables the optimized multi-product, multi-line plants to short new product development and production extension from a pilot to the full-scale production. The equipment functioning is separated from the recipe procedure which results in the enhanced flexibility. The modularity and consistency properties are introduced by the breakdown and terminology of equipment entities and procedural elements. The ISA-95 standard is used to help define boundaries between the enterprise systems and the control systems. In their turn, these boundaries help in answering such questions as 'which tasks can be executed by which function?' and 'what information must be exchanged between applications?'. The added value of these standards is in controlling and documenting the IT-project lifecycle following pharmaceutical best practices (GAMP-5) and easier validation of the IT and production systems. This Product Lifecycle Management approach reduces costs, risks, management of changes and precious time in New Product Introduction. To clarify this approach, a few examples of best practices with major Pharmaceutical and Biotech multinationals are presented.
Book: World Batch Forum 2011 North American conference
Publication year:2011
Keywords:ISA-95, production