While most architecture in the world is devoted to creating environments for human occupancy, who is tasked with designing facilities that manufacture drug products to occupy humans?
If you have been immersed in the business and/or science of developing a new drug for the last 20 years and are fortunate enough to be thinking about a manufacturing facility for your new Phase III blockbuster biotherapeutic, trying to navigate the sea of starting point options may be your next big life challenge. Depending on the size of your organization, your experience, and perhaps your geographical location, you may or may not have access to the resources needed to kick this effort off. As you embark on finding a firm to guide you through the process and design your facility, you might hear confusing terms like Lab Planners, AE (big A, little e or big E little a), healthcare/institutional architects, EPC, EPCM, EPCMV, design-assist, design-build… and the list goes on. All these terms may be relevant to your quest at some point, but if you really need to build an FDA compliant bioprocessing facility, there is a term that you may want to focus on first, process architect. Not the type that designs IT infrastructure or commercial office complexes or stadiums, but one with the highly specialized skills and experience required to design a facility to make drug products that are safe for one of the most intricate and sensitive communities in the world, the human body.
Billions of dollars are spent each year to research and develop new and improved therapies meant to defend, mend and extend human life. Once your therapy advances to a stage that inspires commercial development and investment, it’s critical that the facility where that therapy will be manufactured be designed to mirror the level of sophistication of its final human host. Therein lies the role of the Process Architect and “their process” to extract, understand and organize the volumes of requirements into a compliant matrix of logical compartments that emulate regulations, unit operations, safety and efficiency. A qualified Process Architect applies the appropriate regulatory requirements, engineering data points and process information available to make sense of your process, architecturally and operationally.
In recent years, the art of bioprocess facility design and the experience that was needed to understand its many fundamentals was thrown against a wall and smashed into hundreds of small parts. To make the change even more profound, the parts move and more often than not, get replaced by many other parts that must be received, stored, cleaned, serialized and organized to avoid confusion and cross-contamination. Flow through the corridors of a highly utilized facility has become a congested superhighway of materials that were once hidden in “the process” and are now ushered by human hands to their interim destinations. The process architects for the next generation of manufacturing facilities will need to breathe in these new operating dynamics in order to engineer solutions that integrate hybridized platform bioprocesses and reduce the boundaries of clean travel. They will need to understand more than architecture and the published regulations; they will become experts on the technologies themselves.
At INTERPHEX 2015, the subject matter experts and process architects at IPS will again be organizing technology tours to assist you with where to start your project. They will provide introductions to the many new technologies in bioprocess that are shaping future manufacturing environments for drugs that will occupy humans.
This article originally appeared as a supplement to the 2015 IPS Technologies Tours at INTERPHEX.