Friday, May 29, 2009


Bridge RandD-Manufacturing Gap

Information technology can smooth path to new products

The changes the pharmaceutical industry is going through are nothing short of revolutionary. These include new technologies, a shifting regulatory landscape, increasingly intense competition, diversification of the market and industry, demographic evolution, and changing consumer behavior. Pharmaceutical companies are facing patent expirations and fierce competition from companies that manufacture generics, which forces them to focus strategically on the search for new and innovative products. The trend toward individualized medicine is a factor as well. Finally, consumer demands are becoming increasingly complex and varied as product life cycles shrink.

This combination of factors-together with regulatory compliance issues-generates process and system requirements that must be adhered to. It also highlights the need to speed up the introduction of new products while reducing failure rates, moves that will secure market share and lead to growth opportunities.

All these factors mean that research and development play a key role when it comes to a company'S commercial success. But success does not only depend on a company'S ability to combine timely and insightful product innovation with quick global time to production and time to market. Success is also heavily dependent on the company'S ability to attain manufacturing efficiency and cost containment.

More business executives have come to understand the indisputable necessity of streamlining their research and development (RandD) processes and developing a platform that will allow for a fast, easy, and consistent transfer of final product designs to manufacturing plants worldwide. Integration of RandD and manufacturing is the key to innovation and efficiency and, ultimately, excellence.

Integrated Quality

A number of regulations have been instituted worldwide to enforce new comprehensive initiatives in risk management, data integrity, and integrated quality, as well as more stringent product liability regulations.

In the past, the introduction of innovative systems in pharmaceutical manufacturing was discouraged due to regulatory uncertainty, but the launch of initiatives on pharmaceutical current Good Manufacturing Processes (cGMP) and Process Analytical Technology (PAT) by the Food and Drug Administration (FDA) has ushered in a new era.

The focus is on innovation and efficiency, as well as a risk-based approach to manufacturing and quality. This approach means quality must be built into the processes. Integrated quality requires a thorough understanding of these processes, as well as of the effects of different events and process steps, with the goal of ensuring final product quality.

The continuous stream of process information obtained from on-, in-, or at-line measurements of critical quality and performance attributes needs to be stored and analyzed in order to offer optimum insight into the processes and detect deviations as they happen. The eventual goal of this approach is a real-time product release based on data from predictable processes.

In its guidelines, the FDA states that processes must be reliable and repeatable in order to guarantee quality and safety. Inherent in the FDA'S risk-based regulations is the standardized approach, with a clear preference for using customary products and solutions based on international standards to facilitate technology transfer.

Demands on IT

All of these factors mean that a very complex set of demands is placed on the back of information technology (IT) systems, on both the process and control levels, as well as in production and on the business level. Built-in quality in the production process can be achieved solely through the integration and interaction of systems.

A standards-based manufacturing execution system (MES) with integrated product specification management and laboratory information management systems (LIMS) serves as the single point of reference for all quality, product, and process data. The data are thus transformed into business and product value. LIMS is the point of reference for the quality parameters, managing work-flow and samples in the lab. Linking the quality parameters from the LIMS with the process parameters accessible in a history integrates quality into the process. This data can then be fed back to the control systems, thereby completing the loop and assuring real-time measurements of parameters critical to quality.

The effective adoption of cGMPs and key initiatives like those promoted by the FDA offers dual incentives. Besides allowing a company to check off the compliance box, they prove equally beneficial to its cost base and time to market, providing a significant competitive advantage.

The pharmaceutical industry has long been in an enviable position when it comes to efficiency and productivity, so much so that cost efficiency has been a far less pressing matter for pharmaceutical companies than it has been for those in other industries.

This was just as well. Due primarily to regulatory issues, the pharmaceutical industry, in comparison with some other industries, has long been somewhat hesitant to adopt new strategies, systems, and methods to increase productivity.

More business executives have come to understand the indisputable necessity of streamlining their research and development processes and developing a platform that will allow for a fast, easy, and consistent transfer of final product designs to manufacturing plants worldwide.

But patent expirations, generic competition, and drugs changing to over-the-counter formulations have made double-digit growth a thing of the past. In addition, the cost of introducing a new drug has more than tripled over the past 15 years. Because revenues from blockbusters can no longer offset these costs, pharma companies have intensified their search for methods to reduce both time to market and costs. As in the past, pipelines need filling, but cost containment and efficiency matter much more. The emerging importance of personalized-or customized-drugs further underscores the importance of highly flexible manufacturing, cost savings, and time to market.

Pharmaceutical companies must also prepare to adopt innovative technologies aimed at increasing drug manufacturing efficiency through customization and disposability. This includes new technologies or methods such as disposable process containers, lab-on-a-chip analyzers, miniaturization, micro technology, and more. In addition, more company executives realize that, while it is vital to optimize their RandD activities, that strategy alone is not sufficient. To obtain the right level of efficiency, RandD activities must be integrated into the organization'S structure.

Integrating RandD and manufacturing with an appropriate system and platform is vital to the future success of pharma companies. This integration offers the dual benefit of speeding up the development of new products and increasing manufacturing yields dramatically, thanks to an approach that emphasizes doing it right the first time. Closing the gap between RandD and more flexible manufacturing also allows companies to be more responsive to market needs and demands, which helps to reinforce their image.

To this end, RandD and manufacturing must establish an exchange of information. Cross-disciplinary data sharing and consistent data management make up the cornerstone of an efficient, collaborative RandD and production process. Everyone involved in the new product development and introduction process needs to become part of an integrated workflow using a standard data structure that offers the possibility of establishing cross-functional collaborations.

Knowledge attained during manufacturing can be reused during process development for new products. In this way, production and equipment capabilities are already taken into account during the development phase of a product and process. The result is a smooth final product and process design transfer to manufacturing plants around the world.

Typical RandD activities-project management, formula and packaging development, trial and experiment management, and production process design-require an integrated set of best-in-class components. These range from workflow management, electronic notebooks for laboratory management, specification management, batch and inventory management, pilot plant manufacturing, and the like. Key functionalities like regulatory compliance and support for the intellectual property process have to be part of such a platform. RandD-related functions must be woven into the manufacturing execution system (MES). This is facilitated by the ability to use the same sample management and LIMS in both development and manufacturing.

Streamlining Product Innovation

There are a number of tools out there that can address various aspects of these issues, but many in the business saw a need for a platform that would manage the entire RandD process in a structured, yet flexible, manner. Companies wanted something that could take a new project from RandD through final product design and smoothly transfer it to manufacturing. One system that attempts to meet these needs is the Siemens Simatic IT RandD Suite.

The suite can work with electronic lab notebooks, LIMS, specification management, and other tools. And, because it is fully based on the standard framework of the Simatic IT Production Suite (Siemens MES), it uses the embedded modeler to optimally access all functionality offered by the MES system to cover cross-disciplinary activities. (A few of these features include order management, material management, historian reporting, overall equipment effectiveness, and down-time management.)

Such a suite can be the key to a successful RandD strategy because it allows companies in process industries to capitalize on their RandD potential and develop products faster. It offers a scalable and flexible platform to streamline, optimize, and align all RandD-related processes with manufacturing. It keeps the product designs and processes in line with quality and regulatory requirements. The smooth integration and alignment of RandD and manufacturing data and processes drastically speeds up the transfer of final product designs to mainstream manufacturing. �

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