by Nick Hutchinson
Once upon a time, this seemed like a very easy question to answer. Engineering companies designed facilities with stainless steel equipment to the user requirement specifications of their biomanufacturing customers. These biotech companies then operated the facilities, producing quantities of product to supply the market. They understood these products, having developed them in-house, and had designed, characterized and scaled-up the required bioprocess. They put in place the quality systems necessary to ensure the safety of their patients. In short, these biopharma companies were vertically integrated with competencies in developing, producing and marketing their products in a tightly regulated market. To better serve their customers they invested in manufacturing sciences leading to process innovations that lowered costs, increased throughput and improved product quality.
Leading biopharmaceutical firms still see biomanufacturing as a core competence. Amgen, to give one example, proudly states in its 2016 Annual Report that the company’s “long record of delivering reliable supplies of high-quality medicines with improving efficiency is a source of differentiated competitive advantage”.