One of the earliest and most important decisions in a biopharmaceutical facility construction project is choosing a project execution strategy. This choice affects cost, schedule, and quality of the immediate project as well as further operations throughout the facility life-cycle.

As technology and best practices evolve in the early 21^st century, many biopharmaceutical facility projects are integrating some form of modularization execution strategy to maximize predictable costs, schedules, and quality benefits. The modularization concept can manifest as prefabricated buildings, modular process skid systems and HVAC systems, and preengineered modular construction techniques.

Here we focus on a preengineered modular construction project execution strategy adopted by Cook Pharmica for its new biotechnology active pharmaceutical ingredient (API) contract manufacturing facility in Bloomington, IN. This project won the 2007 Facility of the Year award for facility integration from the International Society for Pharmaceutical Engineering (www.ispe.org). That award confirmed the success of integrating a modularization concept for meeting the goals of this biopharmaceutical facility project.

Cell culture room in the Cook Pharmica facility. (Click to enlarge)

Background

Back in 1963, a legacy of innovation and quality began in Bill Cook's spare bedroom in Bloomington, IN. This is where Cook Group, Inc.'s first “factory” was located — where Bill Cook manufactured, stocked, and marketed custom-crafted medical devices. Today, Cook Group is a leader in developing health-care devices used by physicians and hospitals all over the world. With offices worldwide, the company is at the forefront of medical research and product development in minimally invasive medical-device technology for diagnostic and therapeutic procedures.

Cook Pharmica has built a technologically advanced facility with the capacity to expand as its clients scale up from process development through clinical trials and into commercial manufacturing. The company will use mammalian cell culture to produce biopharmaceuticals for clients. Building on the grounds of a former Thompson Consumer Electronics (RCA) television assembly plant, the project was taken from conceptual design to a fully functional, tested, and validated facility in 26 months. It consists of two independent buildings, each encompassing about 450,000 ft². Other locations were evaluated, but this site's bilevel layout was ideal for the placement of the bioreactors, which are suspended through the floors between levels.

Project Delivery Approach

Once a business plan and functional strategy for this facility were developed, an in-house team began to examine which project delivery method would best suit the company's needs. This team established criteria for a delivery approach that prioritized CGMP compliance on a fast-track schedule and emphasized single-source responsibility as the best way to manage the complexity of the project.

“Time-to-market” was an especially important consideration in selection of a project execution strategy. The business case for this new facility included biopharmaceutical industry and patient needs to move products from laboratory to commercialization as rapidly as possible. Return-on-investment (ROI) was another driver for recouping the expense of capital for facilities and equipment, operations, engineering, construction, start-up, commissioning, and validation.

Modular systems with preengineered performance criteria served as the foundation for this project. Inherent benefits of modular methodology include concurrent engineering and procurement tasks. Combined with the compressed field activities of modular construction and integrated commissioning–validation approach, this effectively reduced the overall schedule while ensuring regulatory compliance at every phase of the project lifecycle (Figure 1). The company maximized modular construction benefits by integrating a preengineered, modular CGMP architectural cleanroom core, mechanical systems, building automation, and modular process equipment.

Figure 1: (Click to enlarge)

After a rigorous due-diligence process, Cook established a cross-functional project team of modular system design-and-build experts. This team included members from AES Clean Technology, Inc. (www.aesclean.com) for preengineered modular cleanroom systems, CRB Consulting Engineers, Inc. (www.crbusa.com) for modular process expertise, and a local construction firm, R.L. Turner, Inc. (www.rlturner.com). The team would combine preengineered, modular construction with a coordinated facility design and construction approach for flexibility.