Purpose-built informatics solutions improve enterprise level productivity for pharmaceutical companies and their strategic partners

By Gary Walz, Senior Product Manager, Thermo Fisher Scientific

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.

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.

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.1 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. 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.

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. 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.

Purpose-Built LIMS Enable Faster Installation, Validation and ROI

At Thermo Fisher Scientific, we believe that 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.

Thermo Scientific Darwin LIMS™ is a fully validated laboratory and data management system that is being successfully implemented worldwide by many of the largest pharmaceutical manufacturers. Darwin LIMS is a clear example of the benefits of purpose-built LIMS solutions, specifically designed to address, out-of-the-box, the unique needs of pharmaceutical manufacturing R&D and QA/QC laboratories, to help them meet regulatory and government standards, achieve significant time savings in validation efforts and generate cost savings in personnel and production time.

Darwin's unique batch and product-oriented design aligns directly with the pharmaceutical 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.  Darwin LIMS also includes built-in, dashboard-ready functionality to allow pharmaceutical laboratory managers to make faster, more informed decisions. 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.

In addition, Darwin LIMS contains an environmental monitoring module as standard facilitating product quality monitoring and compliance. Additional standard functionality includes 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. This built-in functionality is a critical component for the pharma manufacturing process and enables 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 Darwin 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.

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 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 like Thermo Scientific Darwin 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. 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.

References

1. Strategic Analysis of US Laboratory Information Management Systems (LIMS) Markets (Frost & Sullivan, 2008).

For more information about Thermo Scientific Darwin LIMS, please call +1866-463-6522 (US), +44 161 942 3000 (EU), visit marketing.informatics@thermofisher.com.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of more than $10 billion, we have approximately 35,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications. Visit www.thermofisher.com.