The development and launch of new biopharmaceutical products is a very challenging and risky process. Sponsors must get their products into clinical testing as quickly as possible to beat their competition and take the greatest share of the market. Yet that need for speed must not lead to companies launching products with inefficient manufacturing processes that ultimately will leave them vulnerable to attack from low-cost competition. Single-use systems have been a significant enabling technology for companies developing new biologics because of their inherent flexibility and low upfront costs, which help mitigate financial risk during process development.
As the technology has matured, more companies are becoming interested in widespread adoption of single-use systems even in commercial production settings. That would allow them to take advantage of the same flexibility of single-use technology while creating agile manufacturing networks that can respond to variations in demand, readily produce multiple products with fast changeovers, and facilitate new product introductions in the future.