Pharmaceutical Manufacturing and Scale Up Process

The biopharmaceutical sector in US enjoys 17% of all domestic R&D funded by the country and in return gave $2.5 trillion cumulative addition in economic output in 2016. Companies involved in the pharmaceutical manufacturing have grappled in recent years owing to the largest waves of drug patent expirations in history. As a consequence enabling low-price generic drugs to inundate the market.  Many pharmaceutical manufacturers have contended with intensifying competition from generic manufacturers and cutting into revenue growth. Until the next five years till 2022, investments in research and development that generate a high return will occur as many pharmaceutical manufacturers strengthen their drug pipeline with orphan drugs.

Recently, engineers have shown inclination to single-use, modern and continuous manufacturing technologies to improve efficiency, safety and minimize scale-up steps and technology transfer problems in the pharmaceutical industry. Lot of these innovations are driven by updates instigated by the FDA. The changes are inevitable; especially in the already aging biopharmaceutical sector of the industry, where original processes are overly complex and are characterized by inefficiency, and occasionally, inherent unpredictability.