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Balancing Compliance with Economics: The New Role of Manufacturing

Manufacturing is now seen as central to competitive advantage and executives have turned to key performance metrics to analyze process performance and impact bottom line results.

Continuing pressures on life sciences manufacturing, from increased competition to expiring patents, are forcing organizations to achieve tighter operating efficiencies, while improving their ability to satisfy quality compliance standards.

Pharmaceutical and biotechnology company executives are being forced to focus on operating efficiencies to meet shareholder and customer expectations, while doing what is necessary to meet the FDA’s requirements and expectations resulting from new initiatives like implementation of Process Analytical Technology (PAT) aimed at improved process understanding. Increasingly, companies are realizing that investments which lead to better process outcomes can positively affect quality and profit margins.

For decades, the role of manufacturing in the life sciences industry was to connect the drug development pipeline to the commercial side of the business. Investments were primarily made in R&D and in marketing – with manufacturing considered merely a means to achieving the end product. Less money was spent on significantly improving this “middle link” because profit margins were high enough to compensate for wasted batches and inefficiencies that were considered a cost of doing business.

Commodity manufacturers, such as makers of consumer electronics, have demonstrated that process improvement tools, such as Six Sigma and Lean Manufacturing programs, can save millions of dollars and improve outcomes thereby enhancing manufacturing’s value in the enterprise. As research pipelines and the outcomes of clinical studies become less predictable, patents expire and generics and imports commoditize the biopharmaceutical industry, manufacturing is becoming an important component of margin optimization for life sciences companies.

Manufacturing is now seen as central to competitive advantage – whether it is captive or outsourced - and senior executives have turned to key performance metrics that offer a view into process performance that will impact bottom line results. With the FDA’s encouragement, the use of tools such as PAT is on the rise, not only to meet regulatory requirements, but also to enable a better understanding of process variability in order to make the process more predictable and controllable.

Understanding the Process Across the Organization
While those directly involved in biopharmaceutical processes have always had a more intimate relationship with process data, executive interest in such information is a more recent trend that follows manufacturing’s new competitive importance. Personalized access to production data, combined with a collaborative analytics environment for continual operational improvement can help an organization best use its process data.

Customized to individual levels of interest, (e.g., batch or campaign), data from analytical software offers direct visibility into the manufacturing process that goes beyond simply describing “what” happened during production to providing an understanding of “why” it happened and an enhanced ability to predict and improve production outcomes. From raw materials to finished product, manufacturers can now identify exactly what is driving the success or failure of their processes. With a deeper understanding of their processes, manufacturers can satisfy quality compliance requirements and improve operational efficiency, thereby improving the bottom line.

How IT Solutions Offer Insight
Most manufacturing processes generate large volumes of data, but without timely access and analysis capabilities, turning data into actionable information is difficult and often painfully slow. Tools for powerful statistical analysis, visualization, animation and reporting functionality can help monitor and optimize the entire manufacturing process for global operating efficiency.

As CIOs at biopharma companies make increased investments in software systems to improve manufacturing performance, large quantities of raw data accumulate. These disparate sources create “islands” of data scattered across several systems that are loaded with information about process development and manufacturing that can be leveraged to improve performance. Companies need a way to access the data, extract the information content easily and make collaborative data-intensive decisions faster, even in real-time. Maintaining the batch relationships between data from existing systems without regard to their disparate physical locations – including Enterprise Resource Planning (ERP), Laboratory Information Management Systems (LIMS), Supervisory Control And Data Acquisition (SCADA), Electronic Batch Record (EBR), Manufacturing Execution Systems (MES) and data from paper records at either captive or contract manufacturing sites – delivers a complete collaborative environment for data-intensive decision making.
Statistical and other process and data modeling capabilities can be used to derive new parameters that provide telling insights into actual cause and effect relationships. Calculations and computations are fully validated and the resulting data and reports are validated outputs. Visual reporting capabilities help communicate results more effectively to the right people at the right time so that everyone in the organization understands exactly what needs to be done to cut costs and boost revenue.

Using Software for Problem Solving
To monitor the pharmaceutical manufacturing process properly, readings such as temperature, carbon dioxide levels, humidity, cell density, and elapsed time must be recorded every few seconds – sometimes tracking hundreds of process parameters on a minute-by-minute basis over several weeks. One manufacturing process that illustrates this complexity is chromatography, used to purify a pharmaceutically active substance from the impure process stream. In this process, production specialists must transfer active ingredients at exactly the right moment to ensure that purification occurs correctly. Knowing when to make the move to the next purification step is crucial to success.

Before using an integrated data access and analytical software system, one large pharmaceutical company used time as the indicator for determining when to move the process stream to the next purification step. Production operators moved each batch at exactly the same time in the process, but some batches would turn out with impurities while in others the impurities were properly removed. The operators could not understand why this variation was happening since they were apparently following the same procedure every time. The company needed deeper process understanding to determine the source of the inconsistency in results, and they implemented an integrated data access and analytical software system to help them gain this understanding.

After using advanced statistical analysis capabilities on their process, production specialists learned that time was not the right indicator at all. What mattered most was the cell density achieved in the stage just before the start of the chromatography process. The cell growth varied depending on environmental parameters of the growth process that preceded the chromatography operations, and this was not adequately taken into account by using time as the critical parameter. Once the operators began using cell density as the critical parameter, the success rate was much higher.

Using the right IT solutions can help bring process understanding to the larger organization which can ultimately improve manufacturing outcomes much more quickly.

As process manufacturers search for ways to trim costs and boost revenue – whether that be by increasing yield or speeding time to value – they can view the FDA’s inspections and PAT recommendations as opportunities to better understand manufacturing processes across the organization. Today’s IT tools enable data intensive decision-making that places manufacturing at the center of new initiatives that drive a synergistic balance between compliance and the bottom line.

About the Author: Robert Di Scipio is president and chief executive officer for Aegis Analytical Corporation. Di Scipio’s 23 years of experience includes executive positions with biotechnology, software and technology companies as well as corporate law practice and public accounting. He can be reached at [email protected].

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