Speed and Efficiency in Designing and Building a Monoclonal Antibodies Pilot Plant - A close-up look at Pfizer's biotherapeutics plant under development in Shanbally, Ireland. - BioPharm International

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Speed and Efficiency in Designing and Building a Monoclonal Antibodies Pilot Plant
A close-up look at Pfizer's biotherapeutics plant under development in Shanbally, Ireland.


BioPharm International
Volume 22, Issue 3

ENVIRONMENTAL CONCERNS

Another worldwide Pfizer initiative, called the Green Buildings program, helped guide the planning of the Shanbally facility.

The program seeks to reduce the environmental impact of business operations through the innovative design, construction, and operation of Pfizer facilities, and seeks opportunities to apply these best practices to additional company locations worldwide. Key areas scrutinized in Shanbally's design include energy performance, water conservation, renewable resources, recycling plans, waste management, indoor air quality, and innovation.

TEAM MEMBERS MATTER

One key tenet of the project team was the need to recognize and manage the different project phases, and never to get out of sequence with the design effort. For example, proceeding with the detailed design of a system before the plant piping and instrumentation diagram (P&ID) development has advanced enough would not be allowed because past experience shows the time and cost of rework far outweighs any delay in getting to the appropriate standard before proceeding. Benchmarking also played a role in the design. The team analyzed other biologics facilities, both within the company's manufacturing network and outside it, for key parameters such as cost, schedule, equipment size, and other parameters.

A few other considerations in Shanbally's design process are worth mentioning, especially the fact that good design requires a project team culture oriented around solid design principles. A key principle in this case was to plan for more than simply the ongoing operation of the site. With this facility, design considerations also take construction and commissioning requirements into account. The fact that the designer will commission and qualify the systems ensures that the appropriate high- and low-point vents and system isolation breaks are built into the design, not engineered-in late, after construction is complete. Layouts that maximize construction trade access to equipment are another benefit of designers' being familiar with how construction can be made easier.

In the early phases of the project, the team enacted a formal process for soliciting input and reviews, and then froze the design to allow for consideration of project details. This cycle of review, approval, and design freeze to allow for detail development was followed during both the design and construction phases. A team mindset developed to resist changes as the project moved forward. After a system was deemed safe and in compliance with quality and performance standards, on-the-fly changes would be highly discouraged.

STREAMLINING THE PROCESS

A challenge that was evident from the start was the aggressive schedule, which called for a project timeline of 27 months from start of detailed design to making the first engineering batch. One example of how the team mitigated this issue was by involving the automation team early on, and by working to achieve crossfunctional agreement between the process users, the project team, and the integrator on the design elements. To ensure that the approach was well understood, the team invested time by selecting and preparing a vertical slice of one automation element, the bioreactor pH control system. Process users, project team members, and the integrator made a number of fundamental decisions about major features, including graphic displays, module faceplates, pipe lines and colors, operator prompts, and security access on control modules.

Starting with a clean slate for this facility on a green field site brought advantages and challenges. For the team, this meant that decisions would be based on current good practices and not on site traditions. This is highlighted by how the automation team was handled; most automation team members in Pfizer are located in the offices of the integrator to ensure the quality, functionality, and other standards are built-in throughout the automation systems.

Pfizer Global Manufacturing currently has no MAb commercial or pilot-scale facility in its operating plant network. The project team created its own virtual customer group that included people from different parts of Pfizer who would serve to provide input as an end-user would. This virtual customer included staff members from R&D, from other manufacturing sites, and from central technical groups.


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