By Sidney Backstrom, Executive Director, Business Management, G-CON Manufacturing, Inc.
In the pharmaceutical and biopharmaceutical industry several factors have converged to change the landscape in regard to facilities: the wide scale adoption of single use equipment, greater emphasis on reducing capital expenditures, the need for “in country for country” production, and the advent of personalized medicines and industry focus on orphan drug production to name a few. Such factors militate against the traditional brick and mortar facility approach which is designed for the forecasted global production demand of a blockbuster quantity of product. The expense to build and operate, time to build and validate, single-use nature, and risk of product loss based on building a facility based on forecasted demand, have caused the Goliaths and Davids of the industry to seek a better solution. The search for that solution will inevitably lead the tasked construction project manager to a single word that is often incanted in the facilities world – flexibility. he or she will look for it or be told that he or she needs it in the chosen option.