Biopharmaceutical Manufacturing Trends Toward Leaner, Smaller and More Cost-Effective Facilities

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Researched by Industrial Info Resources (Sugar Land, Texas)--As the biopharmaceutical industry matures, so do planning strategies for production facilities. The industry is seeking ways to build these manufacturing plants at a quicker pace with less complexity, but with high returns on capital investments. This mindset has led to the emergence of non-traditional construction methodologies, as well as equipment reconfigurations and new technologies.

Considering the general construction of cutting-edge facilities, modular system design has evolved from a novelty to a norm and is becoming more widespread in the biopharmaceutical manufacturing industry. The beginnings of modular design were first seen in laboratory construction. However, modular facilities for biopharmaceutical manufacturing are gaining traction and have several appealing attributes. These include standardized processes and training that allow for consistency between sites; modest up-front capital investments; the ability to test equipment before sending it to the facility; the ability to be easily moved to any location (especially to emerging markets); and the ability to be scaled up/scaled out as needed. A typical unit is about 80% complete upon purchase with complete HVAC and other essentials. The remaining 20% can be modified to meet the particular need of the facility. However, modular construction and transport costs are higher, and some firms still prefer the traditional stick-build approach.

Modular construction is most cost-effective in geographies where sanitary piping and proper cleanroom construction are difficult to obtain and administer. However, manufacturers with market exclusivity and high production requirements that are located in large markets may still require traditional methodologies. As facilities become more standardized and less complex, modular costs will decline and the industry is likely to see more construction of smaller, closed processing-type facilities in all markets.

Considering capital equipment, the emergence of single-use technologies has become more accepted and prevalent in biopharmaceutical manufacturing. The most innovative facilities typically include bioreactors in the 500 to 2,000L range. This smaller scale has allowed a new direction in the approach to design and has allowed companies to take advantage of ground-breaking single-use systems (SUS), such as bioreactors, storage tanks and mixing and blending vessels. The smaller-scale facility is more easily managed, and there is less need for steam-in-place (SIP) and clean-in-place (CIP) systems. This results in less complex valve configurations, transfer piping and control systems, which reduce and simplifies the design costs. Also, with smaller equipment and simpler HVAC systems, manufacturers can design their process suites with a simpler, more open layout. These innovations have fewer airlocks and a smaller footprint facility, which in turn reduce operating and capital costs.

With the continued growth in the need for biopharmaceuticals coupled with the intensification in global demand (especially in emerging markets), manufacturers are seeking ways to deliver the highest-quality products in the most expeditious and cost-effective manner. The emergence of cutting-edge techniques and processes will only grow exponentially over time, and engineers, architects, construction managers and vendors will adapt to these changes with a higher level of technology and expertise. This should lead to leaner and meaner facilities, which produce more products to more people at reasonable costs.

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