Considerations To Ensure Successful Scale-up Of Single-use Processes

By Donald Beers

The increasing distance between new molecular entities output and pharmaceutical spending is often referred to as the Innovation Gap. Donald Beers examines the single-use explanation for this and reveals the considerations to ensure successful implementation of single-use automation from laboratory-scale to large-scale production

Recent trends in the biopharmaceutical market have shown a reduction in the number of large companies which are spending their entire R & D budget on developing new drugs1. Instead, start-up biotech companies are the major source of innovation within the biopharm industry and of new molecular entities (NMEs). The main goal of these start-ups with new products or interesting therapeutics is to survive. Survival in this case means getting far enough into the Food and Drug Administration (FDA) approval process to be bought or licensed by a large company.