Evolving Role of the Process Architect

Evolution in the life sciences industry is driving the need for new manufacturing paradigms based on advanced technologies. Traditional approaches to facility design and engineering, such as stainless steel facilities, have a place, but the trend is towards single use. As a result of this, process architects must transform themselves into system integrators to better serve their customers’ needs for fast-track production facilities.

New Manufacturing Paradigms

Life sciences companies continue to focus on breakthrough therapies with accelerated approval timelines. These drugs are high value and typically serve smaller patient populations than the blockbuster products of the past. New drug therapies require flexible manufacturing capabilities in multiple locations worldwide. At the same time, cost pressures continue to mount, not only due to greater competition, but as governments, payers and patients demand less expensive medicines that are clearly proven to be more effective than existing drugs.

In this age of value- and evidence-based medicine, accelerated development and commercialization is essential. The design and construction of facilities that incorporate state-of-the-art construction technologies and take into account both present and potential future needs — all achieved quickly and cost effectively — is a key factor in successful market launches and maintaining production of safe, high-quality drug products.

It is important to remember, however, that system integration isn’t performed for the sake of producing a modular solution. It is intended to provide an optimum solution for delivering a fast- 
track pharmaceutical manufacturing facility with a minimum of risk by taking advantage of modular and pre-engineered solutions that provide the opportunity for parallel construction activities.

All aspects of manufacturing, not just the individual unit operations, must be considered as a whole when designing a modern- day production facility. In addition to the actual process design and production equipment used to make the drug substance, material, personnel and equipment flows, along with the distribution of utilities, etc., are essential factors when integrating a process design with a facility design in accordance with current regulatory requirements. Today’s best solutions allow for reduced construction times and costs, provide for enhanced energy efficiency and minimize risk throughout the project delivery cycle. These goals must be achieved regardless of the pharmaceutical technology being commercialized, whether it is an oral solid dosage drug with a new delivery system, a highly potent antibody-drug conjugate or a personalized gene or cell therapy.

The Move to Modular and Skidded Systems

Equipment suppliers have responded to the evolving needs of the pharmaceutical industry with the development of flexible and compact modular solutions. No longer is it necessary to build from scratch; pre-engineered modular systems ranging from cleanrooms with complete air-handling systems to integrated single-use process skids are now available for most of the components making up a biopharmaceutical production facility.

Importantly, modular solutions are being developed for all aspects of life sciences manufacturing.

There are many good reasons why a project delivery strategy will want to take advantage of today’s modular offerings. Suppliers of modular systems are highly experienced and have the specialized expertise required to design and build their high-performance solutions. Modular suppliers are also able to control the cost and quality of the system they produce at their manufacturing site, which reduces the risks of work slowdowns due to labor issues or inclement weather at the construction site, while improving quality through construction in a controlled environment. At the project site, congestion is significantly reduced when fewer trades are needed to install the modular building systems, pipe racks and process super-skids. It is also important not to overlook the fact that most vendors today offering modular systems provide the in-house design capabilities that give them the ability to tailor their product in certain ways to meet project-specific requirements. It is up to the process architect to understand the range of flexibility a modular system vendor may offer, and demonstrate the additional value realized from integrating the solution into the overall design of the facility.

Modular solutions are being developed to meet the needs of all aspects of a life sciences manufacturing facility. Specialty companies are finding unique and innovative ways to address pharmaceutical manufacturing activities with pre-engineered solutions that are cost effective and significantly reduce the time it takes to build a facility. One notable example is the adoption of modular cleanroom systems with integrated mechanical, electrical and plumbing systems. These modular cleanroom systems offer an obvious method for reducing the time to deliver a project by allowing the parallel construction of the building and the cleanrooms at the same time. Modular cleanroom systems deliver guaranteed quality for the cleanroom environment and allow a single vendor to be responsible for delivery that meets the clients overall system requirements. Advances in single-use component technologies are also moving at a fast pace and should be understood by the process architect when preparing equipment arrangement. Systems that require fewer operators, reduce floor space and are designed for ease of installation and use should be integrated into the process layout whenever possible.


Expanding Horizons

The constant introduction of new, innovative modular manufacturing solutions is creating significant opportunities for process architects to contribute their skills in ways that will have major impacts on the duration and cost of future manufacturing facilities. In fact, the term “process architect” may no longer adequately describe the role played by these highly trained and knowledgeable experts. Traditionally, process architects have been involved in preparing equipment arrangements and the space required to fit a specific process inside a production facility. Today, process architects are expanding their role as technologists and systems integrators focused on finding the best way to deliver a project using modular and pre-engineering systems through the facility design with the clear goal of improving quality, while reducing the cost and time required to deliver a project. The demand for this enhanced role is evident with numerous life sciences companies asking for modular platform designs that leverage modular and pre-engineered components. System integrators and technologists must be aware of new ways to deliver the utility and mechanical systems to a project.

M+W has relationships with equipment and modular solution suppliers from around the world, allowing us to identify the optimal solutions for clients no matter where they are located.

Many suppliers are now integrating advanced modular technologies into their solutions in order to stay competitive with the ever-increasing demand for a kit-of-parts and modular solution that reduces the need for a customized solution.

Importantly, process architects as integrators take on the role of determining how different systems can be brought together to provide the most flexible and adaptable cost-effective solutions for a process intensive facility. Technologists and system integrators with up-to-date knowledge of the ever-growing number of options provided by modular suppliers of solutions for pharmaceutical manufacturing have the opportunity to design tomorrow’s production facility with a built-in delivery model that reduces risk and delivers real cost savings to his/her clients.

Life sciences companies are asking for platform designs that can be repeated globally, which not only reduces engineering labor costs, but also allows modular and pre-engineered systems to be delivered easily and reliably around the world. Today’s advanced single-use process systems reduce the need for customization and allow the standardization of facility design based on the space and utility needs of readily available components. Standardizing on single-use equipment has been a game changer because it now allows a design to be built the exact same way, anywhere in the world.


System Integrators and Technologists for the Future

The modern pharmaceutical manufacturing facility must be flexible and adaptable, not only to having the ability to scale- up to meet increased market demands but also the flexibility to house changing production equipment requirements. This can be complicated by the increasing demand for multiproduct facilities that must operate in a manner that prevents cross-contamination. Facility designs must integrate individual unit operations in such a way as to allow for the optimized flow of personnel, materials and equipment while providing easy access by operators and maintenance personnel. HVAC and other utility requirements most also be considered, in addition to compliance with current Good Manufacturing Practices.

These issues must be addressed whether a new facility is being designed or an existing facility is being expanded or upgraded. Often facility designs must be created while manufacturing processes are still under development. Establishing the optimum solution under these conditions can be highly challenging. Successful system integrators and technologists have knowledge not only about process equipment but also about utility and mechanical systems and building technologies. Examples include modular penthouse solutions and co-generation plants. System integrators should also have an understanding of the company culture and both the short- and long-term goals for the facility and the site it occupies.

With this knowledge, it is possible for process architects to act as true technology integrators across the entire spectrum of pharmaceutical manufacturing activities and project deliverables. Because pre-engineered systems have guaranteed performance with detailed operating specifications, technology integrators are able to work in a small team to provide comprehensive facility solutions. They no longer focus on the building envelope, but on interconnected systems comprising pre-engineered modular solutions that can be rapidly installed, validated and operational.

Providing the Best Solution Cost Effectively

At M+W Group, the focus is on taking the very best solutions that the market has to offer and applying them in the most cost-effective manner for our clients. That means gaining as much knowledge as possible about what solutions are available, and applying them using a client-driven and client-focused approach based on technology integration. This approach is market driven; in today’s competitive landscape, it is necessary to clearly define roles and goals in order to meet our clients’ expectations. With our focus on the big picture from the start of a project, it is possible to identify fundamental, basic needs and deliver plants at the lowest cost in the shortest time while providing the most optimal solutions. To most effectively implement this approach, we work with partners and suppliers across all aspects of pharmaceutical manufacturing. We select whichever organization — internal M+W groups or external suppliers — that can offer the most cost- and performance-effective results. Our efforts are focused, therefore, on integrating what is best, rather than spending time and money to determine how to engineer them from scratch. Our global network is also key to the success of this approach. M+W has relationships with equipment and modular solution suppliers from around the world, allowing us to identify the optimal solutions for clients no matter where they are located.

The Technology IntegrationGroup at M+W

Highlighting the importance of integrating process, technology and facility design, M+W created the Technology Integration Group (TIG). The TIG focuses on business sectors where it can provide superior value through technical innovation while utilizing design tools that leverage our existing portfolio of capabilities. The TIG’s "Road Map for Success" focuses on defining resource needs, strategies, activities and short-, medium- and long-term measurable project results.

The TIG includes three centers of excellence to enable the delivery of the best solutions the market has to offer: small molecule/oral solid dose (OSD) manufacturing, biologics manufacturing and fill/finish. Each team consists of people with expertise in manufacturing technology, technology integration and construction management, with the system integrator strongly supported by the center of excellence appropriate for a given project. By linking the integrator with people that have expansive experience in process design and project delivery, M+W ensures that the big picture approach can be effectively implemented using the latest technologies and considering the latest trends in the industry. The members of the team not only have the expertise needed, but an understanding of how the market intends to deliver the potential solutions that can be applied to a given project — allowing them to identify the lowest cost solution with the highest output.


Specifically, the TIG’s role is to define how the innovative use of modular and pre-assembled components will deliver a fully functional facility design that is easily scaled to match a specific process. Perfecting a combined platform design and integrated project delivery approach allows M+W to achieve our goal of becoming the go-to company for advanced technology facilities.

The TIG expands M+W’s offerings by demonstrating how pre-engineered solutions (platform design) can take advantage of new technology and prefabricated components to better serve our clients. Additionally, the TIG demonstrates M+W’s unique ability to deliver new technologies for measurable advantages over conventional designs and delivery models. Advantages of this approach include reduced times for estimating and scheduling, lower project costs, reduced project risk and increased likelihood for project success.

M+W’s portfolio of projects that demonstrate our expertise in leveraging technology include pre-engineered biotechnology factories and associated support buildings; single-use manufacturing suites for retrofit applications; continuous processing solutions for OSD manufacturing; robotic filling solutions; factory optimization; prototype buildings using modular delivery methods; pre-engineered building solutions for 3-6 month shell delivery; and strategic planning, feasibility studies and high-level concept designs.


Peter Cramer

Peter Cramer, AIA, NCARB, LEED AP, is VP Life Science Facility Design at M+W Group with more than 25 years of industry-leading experience in preparing conceptual and basis of design documents for pharmaceutical and biologics clients. He is a leader in designing cGMP-manufacturing facilities for clients around the globe. A facility design subject matter expert and contributing member to ISPE, Peter is a thought leader who specializes in the planning and design of facilities using disposable-single-use and modular technologies.