While cell therapy remains a very promising approach to developing much-needed new immunotherapies, significant challenges will have to be overcome in order to realize the FDA’s twenty-first century vision of making complex ATMPs widely and cost effectively available to patients.
This article shows how health-based exposure limits (HBEL)-based and process capability-based scales can be combined into a matrix that provides a clear visual guide for adjusting the level of effort, formality, and documentation for cleaning validation based on the level of risk.
DOE is a very powerful tool that can be used to characterize a process. This article discusses several types of experiments, as well as the basic statistical tools and techniques, that can be used when performing a DOE.
This article presents the most recent publication of GMP drug inspection data from CDER, published November 15, 2019 and addressing drug inspections conducted in FY2019. We'll also take a look at seven years’ worth of trends in drug GMP inspections.
A host of factors come in to play when evaluating biocompatibility, including how the medical device is sterilized, how the device is used, what body parts it makes contact with, and selecting testing approaches.
Part 1 of this series provided an overview of CPV and how it is key to setting the foundation for continuous improvement in pharmaceutical manufacturing. In this second part, we will look more deeply into how enhanced knowledge management can enable robust change management in the life sciences industry.
This article, based on the EMA’s European public assessment reports (EPARs) and the FDA’s BLA (biologics license application) reviews, identifies many inconsistencies that require revision of regulatory guidance to ensure faster approval of biosimilars.
With minimal specific guidance on commercial manufacturing from the FDA and a lack of robust platform commercial processes, some of the finer details of cell and therapy manufacturing can make operating companies feel like they are walking on a precarious limb.