This article describes the importance of incorporating critical design elements into the quotation before placing the order, clearly defining roles and responsibilities, and managing the project effectively. The installation was completed on time and on budget without any project change orders.
UNDERSTANDING DESIGN OBJECTIVES
Cytovance Biologics required two mammalian cell-culture bioreactors for its newly constructed, early clinical phase cGMP contract manufacturing facility at the Presbyterian Health Foundation Research Park in Oklahoma City, OK. One hundred liter and 500 L mammalian cell-culture stainless steel units were specified for separate manufacturing trains in dedicated suites. They needed to be operational by the summer of 2006 to support customer cGMP production batches.
Because Cytovance Biologics is a multiproduct contract manufacturer, there was no single product or process to tailor the bioreactor systems to. It was necessary to accommodate a wide range of mammalian cell-culture products and processes to maintain the company's ability to bid on a wide variety of contract proposals. Many design issues were addressed early on, such as the sizing of the mass flow controllers, the addition of baffles to the bioreactor vessels, and whether the bioreactors would be capable of running perfusion processes.
We solicited competitive quotes from three vendors and selected Sartorius BBI systems of Bethlehem, PA (SBBI, http://www.sartorius.de/). We also hired Certified Facilities Corporation, of Seattle, WA ( http://www.certifiedfacilities.com/), as a design contractor to ensure that our formal quotation included process and facility requirements and provided protection against change orders because of design alterations. We sought and received assurances from the highest executive levels at Sartorius that the systems would be delivered within 26 weeks of placing the order.
Finally, we conducted a one-day, face-to-face meeting with Sartorius to tour their facility and identify final bioreactor specifications.
MANAGING THE TEAM
Once we formally placed the order, we established roles, responsibilities, and key contacts for each team. At Cytovance, I was the main point of contact. Steven D. Perry, vice president of manufacturing operations, was responsible for final decisions, and Debra Greiner-Powell director of quality systems, was responsible for quality assurance on the customer side. Steven J. Ruhl, vice president of Certified Facilities, was also a key consultant to the bioreactor project team.
At SBBI, Stanley Hawrylo, senior project engineer, was the main point of contact and project manager. Kenneth Clapp, senior vice president, manufacturing and operations, was responsible for final decisions, and David Koiro, quality control supervisor, managed quality control on the vendor side.
We instituted weekly update meetings by phone, where we took detailed minutes and established a formalized system for tracking action items. The meetings were invaluable—they provided a forum for consistent communication for the duration of the project. The minutes also created a historical record of the project's development, which was reviewed whenever disputes arose. Project teams from Cytovance Biologics and SBBI participated in the weekly meetings throughout the course of the project.