Patient Centricity, Risk Communication and Regulatory Considerations for Continuous Manufacturing

摘要

Continuous manufacturing is currently a hot topic in the pharmaceutical landscape despite the concept having been around for decades. One reason is that the majority of pharmaceutical manufacturing is, at present, accomplished by traditional batch processes. The use of batch processes has several limitations, including the lack of flexibility in batch size to meet potential fluctuations in patient supply and demand. Additionally, if a batch does not meet release specifications and if reprocessing is not an option, the batch may have to be discarded. This can be very costly to the manufacturer and potentially create a drug shortage.