In this article, the author reviews some of the techniques that can yield valuable information on protein stability, focusing specifically on protein aggregation. Emphasis is placed on the enhanced information made available when technologies are used orthogonally, and the alignment of different approaches with specific stages of the biopharmaceutical development workflow.
The authors describe the impact of the knocking of the pgi gene of the wild type MG1655 strain on the growth kinetics of plasmid-free and plasmid-bearing cells.
The recognition that microbial artifacts are capable of modulating the mammalian immune system is an emerging view of biologic drug contamination control testing.
Heightened global uncertainty could slow bio/pharma development activity.
Industry experts discuss what the outsourcing market holds for 2016.
AMRI adds analytical capabilities to its outsourcing services offerings with the acquisition of Whitehouse Labs.
CMO industry consolidation may be frustrated by a dearth of attractive assets.
FDA granted Immunomedics breakthrough therapy designation for the company’s investigational antibody drug conjugate for treatment of triple negative breast cancer.
FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.
CDER’s Office of Pharmaceutical Quality plans on promoting modernization as a way to ensure drug quality.