Driving efficiencies in the pharmaceutical industry: Andrea Tabor, Senior Principal Business Consultant, AspenTech, presents a software solution to drive efficiency in process development across the pharmaceutical industry.

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Today's pharmaceutical companies are increasingly looking to their research and development departments to streamline their process development workflows. At the same time, they are asking their manufacturing units to deliver high-quality products in an efficient, cost-effective manner. Research and development (R&D) costs are rising, having roughly doubled during the last 20 years, and now account for up to 20% of revenues. Manufacturing costs are rising too--up by 25% during the past 10 years and now accounting for more than a quarter of total revenues. These costs need to be reduced for pharmaceutical companies to remain competitive. Other key factors impacting the industry include greater product complexity and ongoing regulatory compliance demands.

In their quest to achieve these goals, organizations are facing a complex mix of challenges. On the R&D side, they are aiming to accelerate product innovation and increase the number of products in their pipeline. The end objective is to develop new solutions more efficiently while also developing viable, cost-effective manufacturing processes, so that the new products can be transferred to manufacturing operations with better process capability and robustness. On the manufacturing side, the pharmaceutical industry must move away from its historic practices of retaining spare capacity and inventory to ensure that no orders are missed. They must be able to produce products and documentation that are right first time and delivered on time with leaner workforces. Overcoming these challenges requires efficient knowledge transfer between a company's R&D and manufacturing departments. It also requires manufacturing to have the tools to enable continuous process understanding and improvement. To achieve this, businesses need to exploit solutions supporting existing synergies between process development and manufacturing, as well as manufacturing optimization. There has been little focus on this area to date. However, it is now being addressed by AspenTech's aspenONE for Pharma software suite.

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Current pharmaceutical development processes are characterized by isolated groups doing excellent work; unfortunately, these groups are not able to easily communicate and collaborate with other relevant units and departments. This results in labour-intensive, non-synergistic and unproductive work processes. Other negative effects include the non-systematic treatment of data, labour-intensive batch documentation and ineffective technology transfer into the first site of commercial API manufacture. This kind of weak DFM (design-for-manufacture) culture is likely to result in new drug launches being delayed. According to Jamie Hintlian, Vice President of AspenTech Pharmaceuticals: "One of the biggest challenges facing pharmaceutical and specialty chemical companies is being able to deliver and share information from a lab environment into a pilot plant and, ultimately, to full-scale manufacturing in an efficient and error-free manner."

Innovative solutions, such as the aspenONE for Pharma software suite from AspenTech, are required to overcome these key challenges facing the pharmaceutical industry today and to enable chemists and engineers to increase capacity, improve margins, reduce costs and become more energy efficient. In this context, one of the key benefits of such a software suite is its ability to drive efficiencies in process development and manufacturing across the pharmaceutical space. For example, the world's largest tabletting site, producing 11 billion tablets a year (AstraZeneca, Gartuna, Sweden), runs aspenONE across its entire shop floor, delivering compliance and reducing the cost of goods sold (CoGs). GlaxoSmithKline has also rolled it out for both its strategic MES for global manufacture and for worldwide API process development. As Hintlian states: "With aspenONE V7, we are significantly streamlining the process development workflow. This is yet another key component in the execution of our strategy to extend our process industry innovation to pharmaceuticals and other batch industries."

The latest release of the software introduces this kind of innovation, helping chemists and engineers to accelerate batch process development and reduce manufacturing costs. In particular, it

* includes a new process development console and GUI enhancements that simplify the modelling of batch processes

* provides improved solubility modelling

* integrates batch distillation with reaction modelling.

Dr Ugo Cocchini, Principal Process Engineer, Team Leader, GlaxoSmithKline (GSK), says: "The software offers us a step-change in our modelling and design methods. In particular, the introduction of Aspen Reaction Modeler and the NRTL-SAC thermo method for modelling separation processes will make a significant difference to how we approach process design." Peter Crafts, Principal Process Engineer, AstraZeneca Pharmaceuticals, comments: "Solubility prediction is of strategic importance to AstraZeneca Process R&D. Our industry is increasingly challenged to deliver efficient and environmentally acceptable processes. Taking just a few physical property measurements and extrapolating them to predict temperature and composition effects on solubility is very desirable. The solubility modelling capability with NRTL-SAC in aspenONE V7 is one of the tools we use in our crystallization process design workflow. It helps to leverage solubility data to optimize solvent choice and processing conditions. We look forward to future developments from AspenTech that will further increase the areas of application."

Additional benefits to pharmaceutical and specialty chemical companies offered by the software include improved efficiency of valuable chemist and chemical engineering resources in process development--freeing them up to do more experimentation and value-added activity in R&D--and reduced risk of pilot plant batch failure by guiding chemists and engineers to a narrower range of tested process conditions. The new release also supports accelerated product development through faster solvent screening, improving yield and reducing waste costs by enabling the chemist and chemical engineer to examine more process options in less time. It also enables process selection to minimize emissions and provides support for environmental compliance reporting. Other key benefits include reduced time to create pilot plant batch records by automating the generation of the batch record from the master recipe, and providing a more thorough tech transfer process to deliver robust products to manufacturing.

Although most of the innovations that have been incorporated into aspenONE V7 relate to engineering users within the pharmaceutical industry, AspenTech's manufacturing software solutions are also helping to drive innovation in the sector by enabling end-users to achieve manufacturing optimization. The focus here is on improving right first time quality, delivering 100% customer supply, managing high product complexity and reducing CoGs. The aspenONE software suite provides well-established data records for both time-based and batch-based data, along with tools for visualizing, trending, analysing and reporting the data. AspenTech is currently working with several pharmaceutical customers on expanding the solution support for Process Analytical Technologies (PAT). There are also tools for planning and scheduling, workflow management and electronic production records.

Looking to the Future

As they look to the future, pharmaceutical companies face many challenges regarding the need to accelerate product innovation and develop and produce new products more efficiently. To respond to these challenges, companies need to look for the best available solutions for process development and production management and execution.

For more information

Andrea Tabor

Senior Principal Business Consultant

AspenTech (www.aspentech.com).