Build new...or upgrade?

That’s the dilemma facing many bio-pharm companies looking to broaden their manufacturing capabilities to meet ever-changing strategic goals.

Growing market demands may favor expansion, which traditionally has meant new plant construction. But current economic uncertainty coupled with high energy costs, is raising a red flag among corporate financial managers who caution against assuming additional capital risk exposure.

As a result, many drug producers are opting to upgrade existing plant facilities to accommodate new product and manufacturing technologies, increase containment levels, and facilitate handling of flammable solvents required for certain types of chromatography operations. Along with this, operators are striving to improve product throughput and speed-to-market through process debottlenecking initiatives designed to enhance clean utility capacity such as water or clean-in-place (CIP) systems.

Another key driver of this trend is the recent increase in bioreactor production, especially as relating to monoclonal antibody products. Innovations in bioreactor operations, especially controlled nutrient and advanced cell line development are helping to provide much higher product yields.

Downstream operating capacity and support functions, such as buffer prep, must likewise be increased to improve manufacturing throughput. To achieve that, manufacturers are employing large-scale usage of in-line dilution of concentrated buffer solutions to supply increased buffer capacity while minimizing the need for large equipment.

Underscoring the challenge that confronts the biopharm industry to optimize its plant efficiency and product market life, several international drug producers are designing and building facilities to manufacture biosimilars (biogenerics).

Many facilities constructed in recent years already incorporate the basic capabilities needed to adopt future technologies, support multi-product operations and meet international regulatory compliance. Although some now employ single-use technology, with the right process engineering expertise they can be easily reconfigured for new product and manufacturing processes.

Modification of existing facilities to produce second generation products is a prudent alternative to improve product speed-to-market and maximize economic return on assets. As a recognized leader in developing projects for the biotechnology industry, IPS has extensive expertise in this type of project application and provides economic and flexible solutions that improve manufacturing utilization.