Today’s life-sciences manufacturers increasingly are working with contract manufacturing organizations (CMOs) as part of their business strategies. Outsourcing can provide flexibility, improve time to market, and reduce scale-up costs. The strategy also helps reduce costs from excess plant capacity and can help exploit specialized manufacturing operations.
But maintaining quality standards and managing process stability and improvement is challenging when a manufacturer works with outsourced sites around the world. Life-sciences companies are still learning to manage their own sites, and hiring contractors with various manufacturing-process data systems adds a layer of complexity.
In addition, the US Food and Drug Administration is focusing on CMO–sponsor relationships as a result of quality problems that have surfaced with increased outsourcing. Sponsors always have been legally responsible for their drugs, regardless where the manufacturing operations take place. It will no longer be enough simply to pass paper records between organizations; FDA wants sponsors to conduct on-site audits at CMO sites just like those they conduct for their own in-house operations.
This new paradigm requires parties to share data and information in real time to enhance product quality and the CMO–sponsor relationship. The right technology tools allow manufacturers to gather and share process data with CMOs while preventing the unauthorized disclosure of proprietary information. Both the sponsor organization and the CMO can have self-service, on-demand, and scheduled access to all manufacturing, quality, and process-development data to support regulatory filings, and to use in process-performance analysis and visibility.
By installing a manufacturing-process intelligence (MPI) software platform, the sponsor and contract manufacturing sites can access all relevant data easily. MPI software must provide easy access to data about raw materials, processing parameters, and process outcomes in a meaningful context. The software should assist investigations and analysis when process parameters are trending near out-of-range limits, for example. When the goal is simply to report the values of one or two parameters, a simple context might be sufficient, but when the goal is understanding for process improvement or technology transfer, multiple contexts (i.e., the organization of related data elements to enable analysis and interpretation) are required to help develop and test hypotheses that explain variability and predict outcomes.
An appropriate data-access and contextualization software platform helps ensure successful CMO relationships in the following ways:
A pharmaceutical company on the east coast of the United States, for example, might work with CMOs in New Hampshire and South Korea to produce one drug. Data generated by both CMOs can be stored in a central database at the sponsor’s headquarters. MPI software allows CMOs to enter data into a Part 11-compliant form with automatic verification settings available through a network connection. The software’s centralized archiving and contextualization capabilities help the sponsor and CMOs collaborate and control the process better.
Benefits for the sponsor include better process visibility and on-demand access to results and other data. Central availability of high-quality data saves time that might otherwise be spent looking for lost spreadsheets and analyzing trends. Life-sciences manufacturers that work with dozens of CMOs often have to send many highly skilled employees to and from remote sites on a regular or crisis basis. With MPI software in place, sponsors can reduce travel and personnel costs and prevent crisis-related disruptions. A software platform enables the sponsor–CMO team to act quickly when things go wrong and requires less time to get the process back on track when deviations or failures occur.
An MPI software platform also can help improve record-keeping and control of intellectual property for the sponsor and the CMO. The platform makes process technology more readily available to the sponsor and for technology transfer (e.g., when working with additional sites or CMOs using the same process). Ultimately, the platform can help sponsors meet regulatory requirements for control and management of the CMO and product. Another advantage for sponsors is better preparation and defense of chemistry, manufacturing, and controls (CMCs) submissions and other regulatory filings and investigations.
CMOs gain similar value from MPI software. They can use the data access and analytical capabilities for their process-improvement programs and for distributing reports to sponsors after internal review. Some CMOs have multiple operations and process expertise around the globe. With the appropriate MPI software platform, they can tap into expertise at many locations for better use of scarce talent.
With better process visibility and on-demand data and reports, CMOs experience fewer distractions from sponsor visits and data requests, and inspections go more smoothly. Ultimately, better process understanding and control leads to fewer production crises.
In the end, a shared MPI software platform enhances collaboration and improves the reliability of sponsor–CMO relationships. Strong relationships, in turn, improve investigational and observational data analysis, enhance process and product performance, and shorten time to market. With the problems of managing data from disparate manufacturers and locations under control, sponsors and CMOs alike can reap the benefits of outsourcing.
Justin O. Neway, PhD, is executive vice-president, chief science officer, and cofounder of Aegis Analytical, 1380 Forest Park Circle, Suite 200, Lafayette, CO 80026, tel. 303.625.2100, [email protected]. Aegis Analytical owns an MPI software program called Discoverant.