Biopharmaceuticals are the fastest growing sector of the pharmaceutical industry, making up about 20% of the market, with annual growth rates of about 8% (double that of more traditional pharmaceutical sectors). To increase capacity and uphold stringent quality and regulatory demands, manufacturers often reassess their operational and technology strategies while focusing on rising manufacturing costs and the pressure of delivering cost-effective new drug products.
Bioproduction can range from small batches to low-cost, high-volume campaigns. Few manufacturers have the required in-house capacity for such a range, so they engage smaller, more agile contract manufacturing organizations (CMOs) and/or adapt multipurpose facilities with modular process concepts and single-use equipment to minimize cross contamination. And advanced process technologies enable standardized functional process modules, which help manufacturers simplify, verify, and reuse designs. Such flexibility allows functionalities to be added or replaced seamlessly.
But operational excellence alone is insufficient to drive product quality and reduce costs. Improved technology infrastructures could save the biopharmaceutical industry millions of dollars annually.
Increased Flexibility
Changing industry standards, evolving drug and treatment modalities, and rising energy prices are leading biopharmaceutical manufacturers to require more flexible processes and production lines. On-demand (modular) facilities could help companies respond to increasing industry needs. Modular processes within a biomanufacturing facility are enhanced by software components to facilitate modular connections. Software allows change within a process, moving each validated module into place according to process demands.
Industrial automation plays a key role in manufacturing. However, hardware is of little use without communication systems and software packages that offer a holistic view to coordinate different stages from research and development to production systems, storage, and transport. Industrial automation software must be intuitive and easily configurable to eliminate the lengthy and complex process of writing and validating programmed code.
With parameterization, automation software becomes easy to implement in biopharmaceutical manufacturing, therefore increasing process flexibility. Parameterization allows a designer to use a function library that covers the manufacturing challenges of biopharmaceutical production. By replacing traditional programming with parameter setting, biopharmaceutical manufacturers can create well-defined processes and limit risks.
Data Collection
Production flexibility is nothing without product validation and regulatory compliance. Industrial automation software is the perfect solution when it comes to data collection, particularly for modular environments. The 21 CFR Part 11 regulation and similar international standards emphasize important criteria for electronic records and signatures. Errors with using paper records are relatively common occurrences that can easily be prevented by using industrial software that automatically archives and reports data from different sources and automatically logs changes and events at any process stage, thereby securing traceability.
Real-time data collection and visualization play key roles in preventative management. A reliable alarm system can predict potential risks for a system well in advance. Modern industrial automation software comes with remote data access, informing key people to take necessary measures by accessing real-time alarms and event information.
Understanding and visualizing a process with its causes and effects allow process managers to place closed-loop measurements on critical controls that ensure high product quality and reduce the possibility of failure and process variation. Online process monitoring also facilitates development of flexible corrective measures through software analysis, which helps users better understand their processes and implement continuous improvement measures.
Reducing Costs
Intelligent industrial automation can help manufacturers reduce costs in their biopharmaceutical productions by ensuring that expensive materials are not wasted and processes are streamlined. Software helps biomanufacturers visualize all manufacturing activities and process stages, which is essential to analyzing production and energy efficiency. That allows process managers to identify the most intensive stages and visualize how they can optimize overall operations.
Biopharmaceutical companies are already experiencing a gentle transition from “one-line, one-product†setups to agile, multiproduct facilities for managing current and future manufacturing. The transition might not be straightforward or rapid, but it is a journey that can be facilitated by next-generation industrial automation software.
Robert Harrison is industry manager, pharmaceutical, at COPA-DATA headquarters, Karolingerstrasse 7b, 5020 Salzburg, Austria; 43 662-431-002-218; roberth@copadata.com.