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
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:
- Forethought, flexibility, and details of the project plan are major contributors to a project's success.
- Experience, open-mindedness, and communication within the project team are critical to a successful project execution.
- When the project plan and team responsibilities are adequately defined and managed, teams cooperate to overcome obstacles.
Projects whose standards apply universally throughout an organization, regardless of their fit to specific unit operations,
accrued excessive costs and schedule delays. Software, test plans, and other items had to be "re-invented" simply to meet
stringent standards. In other cases the plant-wide strategy or standards were outdated.
In the areas of scope definition, development practices, and team leadership, the study revealed:
- Bioprocessing company engineers generally have very few major project opportunities during their careers, and while each experience
is highly educational, their overall expertise is stymied as a result of the limited opportunities.
- New technologies, particularly automation and instrumentation, continue to evolve, and it's difficult for a customer to gain
and retain current expertise in all areas of bioprocessing operations.
- Few customers solicit feedback from suppliers prior to releasing formal request for quotes (RFQs). Once a formal RFQ is released,
most company purchasing practices severely restrict the amount of dialog between the company and potential suppliers. This
practice places the emphasis on obtaining competitive bids rather than on discussing flexibility and innovative alternatives.
- Large organizations with multiple project engineering teams rely on engineers rotating from project to project to share best
practices — with inconsistent results. Furthermore, while this rotation system often applies to customers with multiple locations
within a country, it is rare to see team members rotate across borders and oceans. Despite professional publications and societies
encouraging companies to share best practices across an industry, confidentiality concerns often result in a "watered down"
version of the best practice being outlined in publications and at industry seminars. Third-party engineering firms help bridge
this gap, but expertise in these organizations varies, depending on their size and depth of knowledge.
- Neither the customer nor the supplier likes change, and the impact of a "moving scope" is always underestimated. Depending
on the timing of the changes, scope adjustments that seem minor can require substantial engineering hours to rework numerous
detailed documents. Such changes can trigger a cascade effect that delays drawings, procurement of materials, mechanical assembly,
automation development, factory acceptance testing, shipment, installation, and start-up.
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.
ALLIANCE FEATURES AND BENEFITS
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:
- Reducing risk by offering single-point project responsibility (one primary contractor), allowing the customer to define process
requirements and eliminating the need to communicate requirements or changes to multiple parties. The customer's process can
be managed by the alliance as a single product recipe, with single-source responsibility for the fully integrated process.
The primary contractor is responsible for making the process train work as specified.
- Single-source responsibility means warranty-related issues are streamlined, eliminating confusion about whom to call or who's
responsible. Both SBBI and Emerson offer product support from service centers located worldwide.
- Turnkey project cost, eliminating gray areas within the scope definition.
- Unified plant-wide automation strategy, eliminating islands of automation by minimizing the number of suppliers working independently.
When properly created and implemented, a plant-wide automation strategy can address a phased-in approach and minimize the
costs of future upgrades.
- Establishment of appropriate and detailed written design standards, eliminating unnecessary complexity and costs resulting
from using inappropriate or outdated standards. The SBBI-Emerson alliance maintains the design standards, assuring that standards
remain current and use the latest technologies.
- Modular automation allows sharing of a common library of control modules, eliminating the risk of having like or similar control
strategies implemented by people using different styles and approaches. From an operator's viewpoint, the implemented controls
look, feel, and perform in a consistent and predictable manner. From a validation viewpoint, control modules are developed
and tested once, but used as many times as necessary. This not only simplifies module validation activities, it reduces maintenance
and engineering costs.
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:
- Progress and scorecard reviews. Central to the alliance's success is a list of mutually established key initiatives that are
required to bring added value to the relationship (a "to-do list"). Progress scorecards should be updated and reviewed by
executive sponsors and the steering committee to ensure that expectations are met and progress is being achieved.
- Resolving roadblocks. Conflicting requirements often arise. When the respective core teams can't resolve these conflicts,
executive sponsors should help reach an acceptable solution.
- Customer feedback. Because sponsors are engaged with customers every day, they are able to provide the team with a unique
"customer" perspective. This can be as simple as a recommendation for an added feature or as complex as replacing an automation
or control strategy.
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:
- Developing the technical solution, including modular automation and modular mechanical platforms. This can include such things
as a unique control and information protocol design, or a robust and reusable interface between plant floor information and
- Managing software and hardware updates and upgrades such as evaluating and detailing the impact a software patch has on operations,
or evaluating a supplier's latest feature enhancements.
- Qualifying new instrumentation, controls, and other process technologies relevant to the client's operations such as evaluating
the suitability and possible benefits of a new sanitary valve, pressure regulator, or flow meter.
- Assisting in the introduction of or development and deployment of PAT solutions such as examining the integration of new analytical
sensors and measurement devices, or evaluating the impact on costs, quality, and throughput of automating a manual process
- Ensuring worldwide project-to-project consistency such as sharing what was tried, what worked, what didn't, and why, thus
avoiding the "re-inventing the wheel" syndrome.
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:
- A secure Internet portal for posting and managing project notes, process and instrumentation drawings, functional requirement
specifications and detailed design specifications, technical data, status updates, and discussion threads.
- Project tracking that allows everyone to share ideas on project pursuit or to plan joint sales activities at a local level.
- Marketing collateral in the form of common sales presentations used by both organizations to communicate the value of the
relationship to potential clients.
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
Leonard J.Goren, editorial advisory board member,and consultant in drug device development and manufacturing, 610.442.6262, fax: 610.395.0221,
. Todd E.Hannigan, global OEM director, Emerson Process Management, 407 West Vine Street, Hatfield, PA 19440 215.362.3705, fax: 215.362.3687,
1. Taylor S. Technology The Third 'Arms Race' in Biomanufacturing. BioPharm Intl. 2005 February. http://
2. US Food and Drug Administration. Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach. US Food and Drug Administration
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://