Goal to deliver innovative analytical, development and manufacturing services with an emphasis on quality reached with renovated facility

When Cook Pharmica completed Project Phoenix, its $70 million contract biopharmaceutical services facility in Bloomington, Indiana in late 2006, its impressive construction schedule – 10 months versus the industry norm of 18-36 months – represented just one in an array of outstanding accomplishments.

Use Of New Technology A Priority

From the outset, the project’s designers opted to use as much new technology as practicable. Flexible processing systems along with less stationary equipment (only the 2,500 L bioreactors of the harvest tanks are permanent) facilitated greater deployment of disposable technologies at the facility. The planners also established goals for a paperless system and integrated information technology (IT) platforms early in the process.

Customization between systems facilitated full integration with inventory management, document management, maintenance management, change management, equipment tracking, training and development tracking and customer complaints management among others – all in a paperless and visible manner.

Another achievement, aimed at increasing transparency in the manufacturing process, was the installation of real-time webcams in processing rooms and the control center, to enable customers to monitor the handling of their products live, 24 hours a day from wherever they are located via password protected access.

“We have asked customers if they will be willing, at their discretion, to let the Food and Drug Administration (FDA) monitor the process when we are doing validation runs for them. Whenever a customer approves, we will simply make the access password available to the regulators as well,” says Jerry Arthur, President, Cook Pharmica.

Existing Facility Provides A Strong Foundation

Equally impressive was the minimal environmental stress Project Phoenix imposed on the environment. One major reason for this was that Cook, after a global search for a location, decided to refurbish the long-abandoned, formerly RCA/Thomson television assembly plant, which consisted of two buildings with 450,000 square feet each, to house the facility. Cook’s decision to reinvigorate an unused existing structure had the added advantage of eliminating the thorny concerns associated with new construction.

Phase one of Project Phoenix led to the creation of 124,000 square feet of productive space for offices, one manufacturing train – which offers scale-up capabilities to 2,500 L – and a shell for a second manufacturing train, development and quality control laboratories, and warehouse and process utilities to support the two manufacturing trains, using one of the buildings.

Locating a cutting edge biotech facility in the area provided an obvious upside for community and the region. Thomson Consumer Electronics had relocated its assembly operations to Mexico in 1998, and the site it had occupied for 50 years in Bloomington was earning the reputation of a discarded blight – until Cook acquired it in 2004.

But the compelling business potential was clearly valued by the Cook team. The existing bi-level design of the buildings was well suited for the installation of Cook’s bioreactors, which were suspended through the floor. The availability of the second building would dramatically simplify future expansion initiatives to meet the anticipated growing needs of customers.

Another key accomplishment is the facility’s information technology (IT) command center or the “fishbowl” that serves as the control point for all the software systems and automation in the facility. Biometric scanners are used to ensure that only authorized staff has access to this area in an effort to ensure the security of all data.

None of this, of course, was lost on the distinguished panel of judges at the 2007 (the third annual) Facility of the Year Awards competition sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine. This year, the judges selected Cook Pharmica as the winner of the Facility of the Year Award in the Facility Integration category.

In The Beginning…

Tracing the genesis of the project, Arthur says, “Prior to this, Cook had no experience or reputation in mammalian cell culture, so this was a new venture completely for the company.”

Arthur started with contract manufacturer, Cook Pharmaceutical Solutions (CPS), in 1996, and became president in 1997, after holding engineering and project management positions at Eli Lilly from 1962 to 1993. CPS, which supplied sterile parenterals to biotech and pharmaceutical companies, was acquired by Baxter in 2001, and Arthur helped manage the transition to Baxter Pharmaceutical Solutions until his retirement in April 2002. In August 2003, he returned to Cook to plan the new company, Cook Pharmica, which was formed in April 2004.

“Most of the corporate group felt that we sold CPS too soon and probably should not have sold it,” says Arthur. He noted that when the first phase of non-compete with Baxter ended in late 2003, and after much analysis and study, it was decided to focus on mammalian cell technology because of a clear disequilibrium between the demand and the available capacity. “There seemed to be a hole in the capacity on the contract side. That seemed like an opportunity, and we went for it,” he says.

Founded in 1963, the Cook Group is the world’s largest privately-held designer, maker and global seller of minimally invasive medical device technology for diagnostic and therapeutic procedures.

Over the past few decades, the company has distinguished itself as the creator and distributor of a line of innovative technologies for drug-eluting and bare metal stents, aortic and vascular endografts, catheters, wire guides, introducer needles and sheaths and embolization coils. The company also provides medical biomaterials and contract manufacturing of biopharmaceuticals, vena cava filters and other minimally invasive medical devices for radiology, cardiology, urology and OB/GYN, critical care medicine, surgery, gastroenterology, bone access and endovascular therapies.

Gearing Up For Production

Meanwhile, at the Cook Pharmica Bloomington plant, work has been completed on the development and quality control laboratories. “The development lab is already generating income from a few development projects,” says Arthur.

“We are near the end of the commissioning work of the production train, the bioreactors and the master cell banking area, and are in the process of starting up production. We are planning engineering runs and we expect to do product runs in the first quarter of next year,” says Arthur.

“We really set the plant up to attract the virtual company – one that does not have any capacity and wants to take a product to the development lab and get it into clinical trials. Furthermore, we have put together 2,500 L capacity so we could go to small scale production if the customer needs that.

“That was our original focus and goal. We were sort of shocked by the amount of interest we have received from large pharmaceutical and biotech companies, and we have struggled to get our name if front of the virtual companies.

“We have some of those, and signed a good contract to develop and take a new drug through clinical trials, and we have proposals with several of the well known players in the industry,” says Arthur.

Getting It Done – With The Right People

Turning to the question of team building and project management, Arthur says, “The approach that I used was to first surround myself with trusted colleagues whom I had worked with before, who were compatible and shared the same values and integrity that we needed.

“Then when it came to picking the players, we picked R.L. Turner as the construction manager because we had worked with them in the past. The architecture and civil engineering operations were all done internally, and several of the subcontractors were local and we have relationships with them, having used them on several Cook jobs in the past.”

“We had done several projects in the past with Cook. This was a renovation project of an existing structure and they needed a company that could help with conceptual design and budgeting and take the project to a point where it could obtain FDA approval in less than 12 months. Because of our past performance in similar areas, we were selected,” says Greg Turner, President and CEO of R.L. Turner Corporation.

R.L. Turner was involved in several aspects of the preliminary design, though it did not do the actual design. “We were involved in the preliminary pricing, assistance with determining cost, subcontractors, and we were the general contractor for the office renovations, and the construction manager for the production facility,” says Turner.

Turning to the question as to what might have tipped the scale for the judges in the Facility of the Year Award, Turner says, “As we understand it, this facility is supposed to come on line some 12 months earlier than other facilties of its type. It is also supposed to pass the FDA approval process about 10 months earlier than other similar facilities did in the past.

“This was accomplished by designers and contractors working with each other on a daily basis. The 750 construction document drawings that were issued in the course of the job were instantaneous – as structures were being designed they were delivered to the job site electronically and then implemented into the working drawings.

“We were able to complete a $70 million project in just around 10 months, which is quite unusual for the industry,” says Turner.

Arthur says that after interviewing several engineering firms, they decided to go with CRB Consulting Engineers because of their reputation and experience in biotech plants.

The office building and exterior design firm G.S. Ridgeway was able to incorporate elements of the existing structure into the project design. One notable example relates to the numerous large dock doors that were located on the north side of the building for forty years. During the renovation, the docks were relocated to the southeast side of the building. This not only eliminated an unsightly view but also facilitated a more architecturally pleasing front entrance for the facility. To further enhance the surroundings of the facility, strategic landscape enhancements successfully converted once asphalted areas into green space.

Key Project Participants Engineering design firm: CRB Consulting Engineers, Inc. Office/building exterior design firm: G.S. Ridgway and Associates Construction manager: R.L. Turner Corporation Laboratory design/Plant Utilities: Mussett Nichols and Associates Laboratory engineering: Harry J. Kloeppel and Associates Clean rooms: AES Clean Technology, Inc. Commissioning and validation consultants: Commissioning Agents, Inc. Mechanical construction: Harrell-Fish, Inc. Electrical construction: Cassady Electrical Contractors, Inc. Project Management: Project Planning and Delivery Key Equipment Suppliers HVAC: 16 AHUs: Trane Water pretreatment/WFI and clean steam systems: Spriax/UltraPure Generators: Cummins, Inc. Process control system: The Rovisys Company, Inc. (Emerson Delta V) CIP skids: ESC Boilers: Cleaver-Brooks, Inc. Chillers: York Cooling Tower: Baltimore Air Coil Bioreactors: ABEC and Wave Biotech Centrifuge: Westfalia Separator Inc. Chromatography skids and columns: IPEC and Millipore TFF Skid: Pall Corporation Tanks: Mueller and DCI Flooring: Cornerstone Flooring and Linings Building Management System/Security/Fire protection: Siemens Building Technologies, Inc.

Deviating from its approach in the previous projects, and because it was renovating an existing building, for Project Phoenix, Cook Pharmica partnered with AES Clean Technologies and selected a modular wall construction. This approach incorporated built-in wall covings for air returns and utilities and walk-able ceilings that would allow maintenance work to proceed without shutting down manufacturing areas. In addition, such modular wall construction gives flexibility for reconfiguration of room designs and ease of future expansions.

“We specialize in renovations and we are used to dealing with obstacles and other difficult field conditions, so we were a great fit for this project,” says Robert Satterfield, Corporate VP and Clean Room Design Manager with AES Clean Technologies.

“What made our job easier in this application, which was unusual, was that there was plenty of building space in which to operate. This gave the designers an unusual opportunity for more design freedom, to be more creative and flexible with the configuration and arrangement of the processing areas.

“We were not handcuffed to limit the boundaries of the space. This building, although it was a renovation, it was like working with a blank sheet of paper – it was just a shell and it allowed considerable freedom to innovate,” says Turner.

“AES fits into this project well because of the flexibility of the project design, the speed that AES works at, and Cook because of its structure and use of small committees work very quickly, so we were a great fit.

“Cook was able to take advantage of this as well as our modular system to get the speed and flexibility for instruction,” says Satterfield. “That’s a cutting edge technology in the clean room industry that Cook was able to use to its advantage.”

“We call our product the AES Pharma System and it is the premier modular system in the industry, and Cook has a very high level of quality expectation and we were honored to be a part of that process,” says Sattrerfield.

Impact Of Award

Zeroing in on what the award means for Cook Pharmica, Arthur said, “We are an unknown quantity. Many of our team members have considerable experience but the industry does not know about us because we are coming up from the start.

“So the award is tremendous from several vantage points. ISPE and INTERPHEX in this industry are the trade groups that count. So getting publicity and awareness in ISPE is a fantastic compliment to us – sort of exactly what we need at this point from an exposure standpoint.”