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Purpose-Built Informatics Solutions Increase Productivity for Pharma Companies and Their Strategic Partners

Mon, 08/16/2010 - 11:44am
Gary Walz, Senior Product Manager, Thermo Fisher Scientific

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Outsourcing Trends

As raw material costs continue to rise and more stringent R&D and regulatory requirements are mandated, pharmaceutical companies continue to experience lengthy time to market schedules and the pressure to contain costs is at an all time high. The growth in Contract Manufacturing Organizations (CMOs) and Active Pharmaceutical Ingredient (API) manufacturers is directly related to the urgency within the pharmaceutical community to continue to find more efficient and cost effective methods of delivering their products.                                  

CMOs and API manufacturers provide a time and cost effective way for pharmaceutical companies to outsource intermediate and final manufacturing production, allowing for their activities to be more focused on developing new drug therapies or discovering new compounds.  By outsourcing some of their manufacturing operations and raw materials development, pharmaceutical companies are able to be more nimble in their production and realize cost savings by not having to ramp up for large runs and then see their infrastructure lie dormant or underutilized during less demanding periods.

The Role of Informatics in Manufacturing Settings

Just as pharmaceutical companies are required to comply with FDA and other regulations, outsourced suppliers like CMOs and API manufacturers must be able to provide the same level of compliance throughout the entire process or production line. Furthermore, they must be able to show their pharma sponsors the transparency necessary for them to obtain their data quickly and easily.

And since the sponsor pharmaceutical company is ultimately responsible for the quality and safety of the drug that is developed, they often dictate to CMOs and API manufacturers that methods and processes, as well as Informatics software, are in alignment to facilitate seamless information sharing.  In this way, a reliable audit trail of data management can be traced from R&D, to raw materials production, and through to manufacturing.

dashboards

Because pharmaceutical companies are continuously in search of processes that can help them deliver a consistent return on investment during the patent life of a drug, enterprise level laboratory information management systems (LIMS) are increasingly relied upon as key contributors in this effort. Delivering advanced functionality that is specific to each stage of the drug development process, from drug discovery to manufacturing, sophisticated and purpose-built LIMS streamline processes, automate operations and dramatically reduce costs. LIMS provide superior capabilities by delivering real-time analysis and reports, facilitating regulatory compliance and product quality, integrating with the company’s broader network and providing secure access to key data throughout the organization. And because a LIMS acts as a central data repository for automated processes from across the lab, and brings together data flowing from ERP systems and other company-specific networks, a LIMS is more and more a critical component of Quality by Design (QbD) processes, which require validated workflows and processes in place of traditional linear pass/fail specifications. As the definition of “quality” becomes more comprehensive based on the multi-variate requirements of a Quality by Design process, an enterprise level LIMS will take on the task of tracking and measuring all the variables and reporting out on the accepted quality parameters. Without an enterprise level LIMS facilitating the continuous validated information loop from development through to manufacturing and up to management, a comprehensive QbD process would be next to impossible to achieve.

Not All LIMS Are Created Equal

Historically, industry standard LIMS have only delivered 30-40 percent of specific functionality targeted to each user’s needs, requiring extensive customization to make that LIMS function in that particular setting. Such customization is commonly only possible through the use of proprietary programming languages that are developed and provided by the LIMS vendor or through costly and time intensive use of on-premise IT personnel to manage and maintain this customization. The combination of minimal industry-specific functionality available in a commercial LIMS offering, as well as the often out-dated and/or costly proprietary languages or reliance on a large and skilled IT infrastructure has been particularly troublesome in the pharmaceutical industry. In addition, pharmaceutical laboratories normally create their own user documentation, design documentation, validation scripts, and help files. As a consequence, the implementation of LIMS in various pharmaceutical laboratory settings has typically been a long, costly and arduous process not only during installation and validation, but also in operating and maintaining the system over the years.

EMchart

The growing mandates of global regulatory compliance and long-term data traceability, as well as the complexity of laboratory testing and emphasis on batch versus sample management, have forced pharmaceutical manufacturers into lengthy, expensive adaptations of generic LIMS to meet their specific requirements. Extensive and costly customization, validation and implementation periods, in many cases lasting 36 months or more, have become routine, resulting in decreased productivity. However, with the increasingly higher costs of bringing a new drug to market, pharmaceutical manufacturers cannot afford delaying the implementation of next generation tools that will make them more productive. And because pharmaceutical companies rely on the external services of CMOs for production and API manufacturers for their raw materials, informatics systems are more and more aligned between sponsoring pharmaceutical companies and these outsourced services partners so that processes are consistent, manufacturing protocols are reliably maintained, and data is available throughout the entire chain of production and to management at all levels of the sponsoring company.

Purpose-Built LIMS Enable Faster Installation, Validation and ROI

The challenges facing Life Science companies today can be ideally addressed using purpose-built solutions that provide as much application-specific functionality as possible out-of-the-box to meet the particular needs of various laboratories. When the required functionality is built into the base system as standard, it eliminates the need for user-specific customizations during implementation. This, in turn, results in reduced validation time, shortened deployment and easier ongoing support.

Purpose-built LIMS that are specifically designed to address, out-of-the-box, the unique needs of pharmaceutical manufacturing R&D and QA/QC laboratories are being successfully implemented worldwide by many of the largest pharmaceutical manufacturers.  Because these purpose-built LIMS are designed to meet the workflow of the pharmaceutical manufacturing QA/QC lab, the functionality is built into the LIMS that enables pharmaceutical manufacturing companies to realize achieve significant time savings in installation and validation efforts, to more easily provide the documentation necessary to meet regulatory and government standards, and generate cost savings in personnel and production time.

A sophisticated purpose-built LIMS designed specifically for pharmaceutical manufacturing processes will have a unique batch and product-oriented design that aligns directly with the manufacturing workflow, allowing production data to be logically organized, summarized and reported. This built-in functionality can dramatically reduce costs by increasing production time and reducing the man-hours necessary to perform basic or repetitive parts of the process.  A state-of-the-art purpose-built LIMS should also include built-in, dashboard-ready functionality to allow pharmaceutical laboratory managers to make faster, more informed decisions. And if the system is built on user-friendly, intuitive Microsoft compatible interfaces, this can help facilitate end-user acceptance and support for the process modifications necessary as part of a standardization plan.  

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A key component of any purpose-built LIMS for pharmaceutical manufacturing will include an environmental monitoring module as a standard part of the design which will help improve product quality monitoring and aid in compliance by documenting important parts of the process and the environmental conditions at each stage in the process. Additional standard functionality for a state-of-the-art purpose-built LIMS will include functionality like dissolution and stability testing and product and batch management, enabling laboratory managers to have more control of their processes and more information electronically documented for audit trail purposes. Built-in  functionality such as these described in this article are a critical component for the pharma manufacturing process and enable more real-time information sharing between the pharmaceutical sponsor and its external suppliers, like CMOs and API manufacturers, and also enables faster and more streamlined decision making. 

With a purpose-built LIMS in place at all points of the manufacturing chain, pharma sponsors are assured of the quality of their finished product and have the information they need at each critical point in the production chain to make decisions that maximize value to their shareholders and protect the consumer.  According to a recent industry report (1), LIMS customers are looking for more “out of the box” functionality, as described here, and will expect LIMS development to deliver the associated time and cost savings this specific functionality will bring.  In addition, the trend towards greater instrument and systems integration across the laboratory, as well as throughout the organization via ERP systems, will enable purpose-built LIMS, to deliver the comprehensive management information necessary for making critical business decisions.

Conclusion

In an environment of extreme cost containment, integrated informatics solutions contribute significantly to today’s pharmaceutical manufacturing operations that require increased product quality and compliance with strict regulations, as well as improved efficiencies which can lead to reduced costs. Enterprise-level purpose-built LIMS serve as a common gateway that other informatics solutions (like electronic lab notebooks or document management systems), instrumentation, enterprise systems and enterprise communications tools can plug into to facilitate seamless data sharing and faster, more informed decisions. These systems are capable of storing data and methods in a safe and consistent way, thereby ensuring ultimate data security and integrity as well as effective processing distribution. As a consequence, scientists and researchers are able to easily access data in order to make better-informed decisions in a faster and more reliable fashion. Investing in a purpose-built LIMS and adopting a comprehensive enterprise level integration approach to streamline business processes can allow enhanced collaboration and data exchange.

Enterprise-level integration is crucial in today’s business climate, where near instantaneous response is required by pharmaceutical companies and their outsourcing partners to protect the public and the environment. Purpose-built LIMS enables pharmaceutical companies to more fully integrate the work of the manufacturing laboratory across the organization and to enable collaboration and better communication with their outsourcing partners. In addition, an enterprise level LIMS is an essential component of any Quality by Design initiative, providing the necessary automation, integration and database reporting functionality that ensures all multi-variate data are tracked and measured. The integration of the pharmaceutical company with its external suppliers will facilitate better data correlation and collaboration, end-to-end report generation and more secure data exchanges, with the ultimate goal being to provide management with a dashboard view of the key business metrics essential to running the business.

Reference:  Strategic Analysis of U.S. Laboratory Information Management Systems (LIMS) Markets, © 2008 Frost & Sullivan

 

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