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...
Continuous manufacturing (CM) technologies have recently been implemented in the pharmaceutical industry for process development, clinical trials, and commercial supply. This article is a high-level summary of a recently published ISPE Discussion Paper that details unique aspects of CM related to...
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...
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....
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.
Continuous biotech manufacturing has the potential to achieve greater product quality at lower cost and shorter time to market. Recent advances in fully integrated control systems and a dynamic market make it more relevant than ever.
Douglas B. Hausner
A group of global consortia has given new meaning to the term “collaboration” in the pharma industry. Populated by academia and industry, and...
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...
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...
