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These latest pressures on technology relate not only to the need for improved manufacturing productivity and shorter development times, but also to the need to create smarter manufacturing operations
In 2000 and 2001 in the life sciences industry, production capacity concerns were raised as a result of a rather imperfect process of analyzing assumptions and predicting product successes based on what was in the clinical pipeline. In 2003 and 2004 some of these concerns were relieved as life sciences industry projects, originally initiated to "grow stainless steel," began to come online. However, while these projects were underway, science wasn't standing still. Advances in process development and increased knowledge of the identification and treatment of global diseases added new challenges to the growing list of demands already facing the life sciences industry. The latest trend is the result of gene discovery's ability to help identify sub-populations and the likely demand for smaller volumes of personalized medicines.
Leonard J. Goren
According to a recent Biopharm International article, these latest pressures on technology relate not only to the need for improved manufacturing productivity and shorter development times, but also to a need to create smarter manufacturing operations — those that can easily switch between products and processes without compromising patient safety, product quality, or production efficiency. This importance for speed of response, small-scale manufacturing, and process flexibility introduces a new imperative for the life-sciences industry: an increased need for continued investment of time, money, and human inventiveness in the form of enhanced manufacturing technologies.1
Encouraged by the initiative of the US Food and Drug Administration (FDA) to promote compliance with current good manufacturing practices and fueled by incentives from Wall Street to minimize the time it takes to bring medicines to market, life sciences companies are aggressively engaged in finding suppliers who offer integrated and proven technical solutions.2
One such solution is the result of an alliance between Sartorius BBI Systems (SBBI) and Emerson Process Management (Emerson). SBBI has provided a range of innovative bioprocessing equipment and services to biotechnology and pharmaceutical companies worldwide for more than 35 years. Emerson is a leader in helping businesses automate their production, processing, and distribution operations by combining products and technologies with industry-specific engineering, consulting, project management, and maintenance services.
A joint initiative can streamline, refine, and deliver best practices to the life sciences industry
Each company has significant project experience and has witnessed a variety of project successes. Curious as to why some projects were more successful than others, SBBI and Emerson assembled a team to identify which best practices contributed to a successful life sciences project, and to devise the ways and means of replicating that success in every project. The outcome of the study is a supplier alliance designed to deliver unique value to a biopharmaceutical company.
The SBBI/Emerson team collected feedback from biotechnology clients and major pharmaceutical customers worldwide, as well as from SBBI and Emerson personnel in the US and Europe. The team's analysis revealed that:
In the areas of scope definition, development practices, and team leadership, the study revealed:
With flexible project planning and teamwork as their guiding principles, the SBBI and Emerson team conducted a self-analysis to quantify each company's biomanufacturing experience and expertise domains. The team determined that each company had a significant amount of biomanufacturing experience, including expertise in hardware and software, mechanical and automation, project management, process knowledge, and validation. However, when the experience of the two companies was merged together, the resulting experience profile became world-class.
Encouraged that such an experience base could provide biomanufacturing clients with unique advanced technical solutions that were fully integrated and proven, SBBI and Emerson established an alliance. Through the alliance, solutions for large-scale production plants could be specifically designed to help life sciences companies achieve improved manufacturing productivity, reduce plant design costs, shorten delivery and start-up time, and reduce validation costs. Alliance solutions for multi-purpose plants and smaller-scale facilities would allow the creation of "smarter" manufacturing operations, capable of switching between products and processes without compromising patient safety, product quality, or production efficiency. Such solutions are the result of combining SBBI's in-depth understanding of the bioprocess and sanitary design process with Emerson's unique ability to provide both the automation platform and advanced instrumentation.
A significant goal of the SBBI and Emerson alliance is to learn, refine, and deliver best practices to the life sciences industry. The alliance's best practices include the intent of FDA's Process Analytical Technology (PAT) initiative, which is to employ innovation as well as cutting-edge scientific and engineering knowledge, along with the best principles of quality management to respond to the challenges of new discoveries and new ways of doing business. (Within the context of the PAT initiative, the term "analytical" is viewed broadly to include chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner.)3
Because the SBBI-Emerson team is involved in dozens of projects each year, the team is uniquely positioned to differentiate between sharable best practices and a client's confidential and proprietary information. And, because of their involvement in hundreds of projects over the years, the goal is to include the best of the best practices in delivered solutions.
Consider two variations of a fermentation example. Fermentation is a well-understood process with well-defined process-control characteristics. For a production plant, a company might specify and purchase the fermentation skid (vessel, piping module, and instrumentation) from one supplier and specify and purchase the control system configuration from another. The customer might then arrange to integrate everything and validate the solution onsite.
Under the SBBI-Emerson alliance, the client specifies and purchases a turnkey fermentation system from one source. As a result of the alliance, the best components, instrumentation, and controls are already determined, pre-tested, and documented. Software control modules are pre-developed and stored in a software module library, ready to be assembled to meet the fermentor functionality, including links to such things as upstream and downstream functions and control and information protocol.
Certainly each project has its unique requirements, but the SBBI-Emerson alliance estimates that executing the second scenario will result in a significant portion of the development effort already available when the client has completed specifying the functionality of a system such as the fermentation skid. When this approach is expanded to include module libraries for other unit operations the result should be a substantial savings in cost and time to assemble, test, and validate the control configuration for the complete process train.
From a client's perspective, a supplier alliance — such as that between Sartorius BBI Systems and Emerson Process Management — provides significant advantages and value to the customer, including:
Like projects, no two alliance-client relationships are exactly alike. From the very beginning each should be tweaked, twisted, and molded to ensure the alliance works best for each client. Once in place, the alliance relationship should be regularly reviewed and adjusted as new opportunities or evolving challenges are identified, thus ensuring that the alliance team is appropriately focused on what's currently important to the success of the client's business.
As discussed earlier, most of the reasons that inspired the formation of the SBBI-Emerson alliance were targeted at meeting the needs of the client company. That's what makes this particular alliance unique; both alliance companies recognize that the real measure of success of an alliance is the added value provided to their common clients. Making such an alliance successful requires diligence in the management of three key components — commitment, consistency, and communication.
Commitment comes in many forms. Key to a successful alliance is a strong executive-level sponsor from each organization. Though the alliance primarily creates a technical solution, sponsorship typically comes from the sales and marketing departments, ensuring that a cooperative sales strategy and strong technical solution will be established.
Besides actively promoting and talking up the alliance within their respective organizations and with potential client companies, executive sponsors should be actively involved in:
Consistency is critical to the client-alliance success and is achieved by the core team. The people on the execution team may vary for a specific project, but the core team should remain intact indefinitely. The core team includes representatives from engineering, operations, sales, and marketing and is responsible for execution of the strategic initiatives critical to the long-term success of the alliance. Core team tasks should include:
Ultimately, the core team is responsible for developing the technical solution that combines the experience of both organizations to deliver added value to their common customers.
Communication ensures everyone is on the same page, an especially important ingredient when alliance teams are geographically distributed. Not only must the combined technical solution be world-class, but each organization's sales and marketing teams must also be able to articulate the value of the relationship to the market.
To facilitate this, the alliance core team should develop a set of communication tools to manage both development and implementation of the technical solution. These tools include:
Through working together, the alliance is able to develop a standard solution that incorporates best practices and future needs. By communicating more effectively and sharing project-pursuit strategies in advance, the alliance is able to create a competitive advantage for its common customer.
Much of the innovation for which biomanufacturing processes strive exists in the instrumentation and automation systems that control those very processes. However, for a host of reasons, the benefits, capabilities, and features that originally may have been used to justify purchasing the automation system often remain dormant or unavailable. As leaders of life sciences companies evaluate past performance and establish future goals, the importance and value of engaging a supplier alliance to help develop and implement cost-effective turnkey solutions within a plant-wide automation strategy will become increasingly evident.
Leonard J.Goren, editorial advisory board member,and consultant in drug device development and manufacturing, 610.442.6262, fax: 610.395.0221, email@example.com. Todd E.Hannigan, global OEM director, Emerson Process Management, 407 West Vine Street, Hatfield, PA 19440 215.362.3705, fax: 215.362.3687,firstname.lastname@example.org.
1. Taylor S. Technology The Third 'Arms Race' in Biomanufacturing. BioPharm Intl. 2005 February. http://www.biopharminternational.com/biopharm/article/articleDetail.jsp?id=146347.
2. US Food and Drug Administration. Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach. US Food and Drug Administration web site.http://www.fda.gov/oc/guidance/gmp.html.
3. US Food and Drug Administration. Guidance for Industry, PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. Rockville, MD: Office of Training and Communication, Division of Drug Information, HFD-240, Center for Drug Evaluation and Research, Food and Drug Administration; September 2004. http://www.fda.gov/cder/guidance/6419fnl.htm.