Reduce Costs - Today's pharmaceutical companies are increasingly looking at 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 and cost-effective manner. R&D costs are rising, having roughly doubled over the last twenty years, and now account for up to 20 % of revenues. Manufacturing costs are rising too - up by 25 % over the past ten years and now accounting for more than a quarter of total revenues. These costs need to be reduced to stay 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 overall objective is to efficiently develop new solutions while developing viable, cost-effective manufacturing processes in a way that the new products can be transferred to manufacturing operations with better process capability and robustness. On the manufacturing side, the pharmaceutical industry has to move away from its historic practices of retaining spare capacity and inventory to ensure that no orders are missed. They must be able to deliver high-quality products and documentation on time, first time with leaner workforces.

Lack Of Knowledge Transfer

These challenges require efficient knowledge transfer between a company's R&D and manufacturing departments. Moreover, the tools to enable continuous process understanding and improvement need to be available. To achieve this, businesses need to exploit solutions supporting existing synergies between process development and manufacturing, as well as manufacturing optimization. To date, there has been little focus on this area. However, it is now being addressed by Aspentech's aspenone for pharma software suite.

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. The results are labor-intensive, non-synergistic and unproductive work processes. Other negative effects include non-systematic treatment of data, labor-intensive batch documentation and ineffective technology transfer into the first site of commercial active pharmaceutical ingredient (API) manufacture. This kind of weak design-for-manufacture (DFM) 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 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 the software suite is its ability to drive efficiencies in process development and manufacturing across the pharmaceutical space. For example, at Astrazeneca, producing 11-billion tablets a year at Gartuna in Sweden) runs aspenone across its entire shop floor, delivering compliance and reducing the cost of goods sold. Glaxosmithkline has rolled out aspenone for both its strategic MES for global manufacture and for worldwide API process development.

Aspentech's Solution

The latest release of the aspenone software V7 introduces this kind of innovation helping chemists and engineers to accelerate batch process development and reduce manufacturing costs. It includes a new process development console and GUI enhancements that simplify modeling of batch processes. Moreover it provides improved solubility modeling and integrates batch distillation with reaction modeling.

Benefits Of The Solution

Additional benefits to pharmaceutical and specialty chemical companies offered by the V7 release of aspenone 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.

Driving Innovation

While most of the innovations integrated with 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 first time quality, delivering 100 % customer supply, managing high product complexity and reducing the cost of goods sold. The software suite provides well-established data historians for both time-based and batch-based data, along with tools for visualizing, trending, analyzing 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 focused around the need to accelerate product innovation and develop new products. To respond to these challenges, companies need to look for the best available solutions for process development and production management and execution.

With its feature-rich software suite targeted at delivering process optimization innovations to the pharmaceutical space, Aspentech is currently well-positioned to provide them with the solutions they need. Hintlian concludes: "Aspentech's ability to integrate core processes from drug discovery through supply chain execution supports critical manufacturer programs aimed at improving R&D productivity, design for quality and cost-effective manufacturing execution. By harnessing the power of Aspentech's process optimization software, pharmaceutical companies can focus on the management of value as opposed to assets throughout the product lifecycle."