CDMO embraces ballroom design using closed processing for its manufacturing facility
Wheeler Bio is the newest member of Oklahoma City’s innovative biotech hub. Housed in the ultra-modern Ziggurat building located in downtown OKC, Wheeler is establishing state-of-the-art biomanufacturing in their 35,000-square-foot brownfield space. CRB is leading the engineering and architecture of the GMP drug substance facility that will support innovators seeking agile, small-batch manufacturing services for their clinical trial materials. With closed processing and ballroom design engineered by the CRB team, Wheeler is capitalizing on the latest innovations in cleanroom concepts allowing for agility that will better serve the needs of the early clinical phase developers and which complements Wheeler’s innovative machine learning antibody discovery platform.
Project Details
Client
Wheeler Bio
Location
Oklahoma City, OK
Square Footage
35,000
Kicking off with process closure analysis
Using closed systems is especially attractive to contract development and manufacturing organizations (CDMOs) because it allows for manufacturing ballrooms in a controlled non-classified (CNC) environment. This is a highly sustainable design that can lower both CAPEX and OPEX costs. It also results in an operation that is lower risk to process, product, and ultimately the patient because the environment is no longer “of critical aspect.”
Closed processing allows for multiple manufacturing operations to be performed simultaneously within the same environment because the processes are isolated and protected from environmental contaminants and neighboring operations. Discrete, open operations, where required, can still be isolated by closed environments (isolators) or by suite, as is practical or preferred by the manufacturing company. Separating open operations by suite can sometimes provide additional logistical segregation, if desired, and could benefit scheduling of sequential (rolling) suite turnover and release.
The key to process closure is less about what a manufacturer is doing and more about how they are doing it. In order to develop a basis of design, our team conducted a process closure risk assessment (RA) of the current Wheeler Bio program. The RA identified potential deficiencies in closed system integrity, critical control points (CCPs) and gates for potential contamination. We used a hybrid Hazard Analysis Critical Control Point and Fault Tree Analysis (HACCP-FTA) to evaluate a list of complex scenarios and detailed documentation of the methods used in Wheeler’s operations.
The RA that CRB developed automatically catalogs recommendations for Wheeler’s current practices. It also provides suggestions on appropriate environmental changes to better protect the process, product, and patient. Our work confirmed the closed systems that could be located in a CNC environment. The analysis also determined the necessary measures to effectively close the otherwise open operations.
The RA is a living program, serving as the basis of design and expressing the strategies and measures needed to protect the unit operations from the environment. As products and programs change, the RA can continue to provide the guidance required to make sound design decisions. New assessments should only be required if classes of equipment change or are added to the Wheeler program.
Closed processing ballroom with unique features
The use of closed processing in a ballroom setting delivers cost-effective solutions to Wheeler and its customers. This approach lowers operational labor needs, decreases the number of walls, and reduces air handler size and quantity. It also effectively mitigates the risk of contamination from the environment. This results in lower environmental monitoring requirements and better opportunity for fewer deviations.
Once complete, the project will house lab space, offices, and manufacturing suites serving the therapeutic proteins market. Originally designed as supporting infrastructure for an energy company, the shell boasts unique architectural features and provides vast views of a nearby park and downtown Oklahoma City and is well located to support low-cost CGMP manufacture for both US and international biologics drug developers.
