This report will help study sponsors understand the service areas expected to grow in demand and the geographic trends associated with central lab service provider use to ensure study sponsors are up to date with how industry peers are outsourcing their central lab work. For providers, it will help determine the attributes and metrics critical to study sponsors in their selection of service providers to internally assess your lab’s capabilities in these areas. More.
This article presents the most recent publication of GMP drug inspection data from CDER, published November 15, 2019, and addresses drug inspections conducted in FY2019. We'll also take a look at seven years’ worth of trends in drug GMP inspections.
By Kevin Honeycutt and Erin Graham, Alliance for Cancer Gene Therapy (ACGT)
Daniel J. Powell Jr., Ph.D., and his research team at the University of Pennsylvania have launched a new clinical trial to treat ovarian cancer with a pioneering therapy involving genetically modified T cells. The trial, which has treated its first patient, almost didn’t happen.
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By Terri Love and Youness Cherradi,MilliporeSigma
Moving from stainless steel to single-use assemblies for final filtration helps meet production demands and cut costs. Pre-use integrity and prototype testing and handling are important considerations.
Designed for large biomolecule purification, this strong anion exchange resin features a rigid bead with large pores and optimized surface extenders. Dr. Jiali Liao presents case studies and design features.
Join us for three packed days of case studies and interactive sessions to identify new technologies, determine how to approach automated systems, how to transition to continuous processes, and how to implement best practices in system testing and life cycle management!