Continuous Manufacturing

Technical
Sampling is the selection of a representative portion of the population to make inferences about the entire population. In pharmaceutical manufacturing, samples are drawn from different stages of the process for both controlling process parameters and assessing drug product quality. In the case of...
Features
Continuous manufacturing (CM) is an advancement in pharmaceutical manufacturing technology that provides high assurance of product quality as well as enough flexibility and agility in production to respond to market demands. The decision to invest in CM can be challenging for a company given the...
Features
Innovative technologies such as continuous manufacturing (CM) bring speed, efficiency, and agility to pharmaceutical manufacturing together with enhanced process robustness and assurance of product quality. During CM, material is simultaneously charged and discharged into process unit operations....
Guidance Docs
Authors: Carly Evans (Akebia Therapeutics), Katherine Giacoletti, (SynoloStats LLC), Declan Hurley (Lilly), Robert Ievers [Co-Lead] (Merck), Matthew...
Technical
Although it includes some background material, this article is based predominantly on a series of interviews with SMEs at Eli Lilly, Janssen, Hovione, C-SOPS, and Patheon from October to December 2017. The comments and observations that follow are theirs.
Features
Although pharmaceutical manufacturing is traditionally a change-averse industry, the benefits of continuous processing demonstrated in other industries are beginning to drive interest in its application to bioprocessing. This article reports on...
iSpeak Blog
Everyone agrees on the value of reducing manufacturing costs, and the critical need to keep patients supplied with high quality drugs. Yet the biopharmaceutical industry--traditionally change-averse--has been slow in transitioning to modern technologies...