Bio/Pharmaceutical Facility Design and Operation: A Primer

A Q&A with Michael Lacey of the National Institute for Bioprocessing Research and Training
Apr 01, 2013
By PharmTech Editors


Michael Lacey
This article is excerpted from an article in a series of primers with training experts from the National Institute for Bioprocessing Research and Training (NIBRT) published in BioPharm International (1). NIBRT provides training, educational, and research solutions for the international bioprocessing industry in facilities located in South Dublin, Ireland. The Institute is based on a collaboration between University College Dublin, Trinity College Dublin, Dublin City University, and the Institute of Technology Sligo. Michael Lacey is plant manager at NIBRT and is responsible for facility, equipment maintenance, and support services to the plant’s core business of bioprocessing, training, and research. Although this interview focused on biopharmaceutical facilities, the advice is applicable to any pharmaceutical facility.

Facility planning

PharmTech: What do bio/pharmaceutical companies just starting out need to keep in mind in terms of planning a new facility’s location and construction?

Lacey: There are many factors to consider in terms of choosing location, but some are crucial. First, the reality is that finance and commercial aspects are major considerations. The second category I would look at is the infrastructural side and the existence of support services. Finally, for me perhaps, the most important factor to consider is the people who run the factory. People are the most important asset a company has.

To expand on those three categories, let’s look briefly at the financial and commercial side of things. Corporations are interested in corporate taxes, local taxes, and charges that they will pay in a particular location. They will be looking at their transfer pricing policy. They may have a treasury strategy. They may set up their financial headquarters in a particular location alongside their manufacturing base.

Companies will surely look at the availability of granted training support, and they will be very interested in their cost base; that is, the cost of labor, salaries, wages, transport, and shipping. Very importantly in the European context, companies will be interested in access to markets in certain countries, particularly European Union countries.

Looking at the infrastructural and support services side of things, manufactured product must be brought to the market. Therefore, effective distribution, including storage and freight transport by road, rail, air, and sea, are very important. With regard to a specific location, a company may prefer to set up where there is already a cluster of similar clients with similar requirements. If such a cluster exists, there is likely to be support services available, such as laboratory services, maintenance services, project management, and regulatory expertise as well as educational and research support from nearby institutes and colleges.

The third category, people, is based on who will operate and manage the plant. It is crucial to have a strong pool of talented people who are well-educated, experienced, and flexible. Those people should also have continuing access to training and education.