To assess current trends in information technology, automation, and process control, BioPharm International turned to Rick E. Cooley, market development manager–process analytics, Dionex Corporation, and James Erickson, president and chief executive officer, Blue Mountain Quality Resources, Inc.
Q: What trends do you see emerging in information technology, automation, and process control for biopharmaceutical process development, manufacturing, and quality control?
Cooley: Process control in bioreactors has historically been represented by systems that are focused on controlling the environment of the bioreactor, i.e., providing an environment that is conducive to cell growth. As a result, sensing technologies and feedback control has focused on bulk chemistry and process attribute measurements such as pH, DO2, DCO2, temperature, agitation rate, glucose, etc. This type of control has led to higher cell densities and, in turn, higher yields, but has had much less impact on "controlling" product expression. There seems to be a growing recognition that it is the biochemistry of the cell itself that needs to be controlled if one is going to significantly "control" product expression.
Erickson: Established biotech companies, with approved products already in production, are looking for ways to produce higher yields and lower costs. Application consolidation and integration are therefore big trends at the moment—trying to use fewer applications in more areas and integrating those remaining applications together to improve information flow and collaboration. Premarket biotech companies, scaling up through clinical trials and then full production, are looking to build this harmonization and collaboration into their systems from the beginning, with practical solutions that place an emphasis on compliance and best industry practices.
Q: What application area is growing the fastest?
Cooley: The field of metabolomics seems to be a rapidly growing area, which I believe will have a significant impact on the control of bioreactors.
Erickson: We're seeing rapid growth in asset management. It is typically one of the first systems in place in a new biotech manufacturing plant and is at the core of quality and profitability. Executives need to keep in touch with conditions of assets that could affect getting products through trials and into the marketplace, and quality managers need accurate and complete information about assets to discover the impact of and implement remediation for any problems that arise in production.
Q: What important breakthroughs have you seen in this area?
Cooley: There is increasing recognition of the linkages between cell metabolism and product expression and how these "levers" can be used to influence product expression. There have been some presentations describing the on-line measurement and feedback control of specific amino acids to influence product expression.
Erickson: There are a growing number of enterprise applications designed for the unique compliance and equipment concerns of biotech companies that offer ideal alternatives to engineering workarounds in applications designed for other industries. Moreover, advancements in browser-based applications and improvements in service-oriented architecture have opened up the spread of applications into new departments and integration of best-in-class applications. Advances in security and reliability of wireless technology too have opened up new opportunities for improved productivity.
Q: What obstacles stand in the way of the development or implementation of IT, automation, and process control systems for biopharmaceutical process development, manufacturing, and quality control?
Cooley: Living cells are probably the ultimate example of a multivariate system. In spite of this, multivariate experimental designs are not widely used in biopharma. This is an area of standard practices that requires significant change if greater "control" of product expression is to be achieved.
Erickson: In the current environment, the biggest challenge may be making the business case for IT systems. In the recent past, when investment money was more readily available, justification could be achieved by simply highlighting the compliance benefits to a system. Now, the focus of a justification has shifted to costs of compliance, equipment uptime and yields, and the ability of trained staff to work effectively and efficiently.
Q: What is the future of this area?
Cooley: I believe we will see increasing interest in the area of metabolomics. This will lead to broader use of multivariate techniques to develop process design space and increased use of higher-resolution analytical tools to generate required data to support the multivariate models. Leaders in this area will push for systems that will enable these measurements to be made online to generate more timely data to support multivariate feedback control algorithms.
Erickson: In the short to medium term, consolidation will continue, with greater flexibility in software applications. In the long term, however, the trend will start to reverse, and there will be greater productivity gains in department-specific functionality. Choosing applications today with depth of functionality in critical and core areas will provide more longevity to software implementations.