Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk mitigation.
Cell therapy companies are attracting interest from investors, and drug companies are seeking partnerships and acquistions to accelerate development.
Two main safety issues have been identified in the early-phase clinical trials conducted to date for chimeric antigen receptor (CAR)-T cell therapies.
Growth may be slowing, but outsourcing activity remains healthy.
The authors provide their perspectives on shipping validation.
Contract biopharmaceutical manufacturing has been growing steadily and is expected to reach $4.1 billion by 2019.
Demand is driving expansion and consolidation of formulation and clinical trial materials services.
The agency detailed its 2015 achievements in an annual report.
The agency provides guidelines on generating histopathology data in nonclinical biomarker qualification studies.
FDA is advising there may be serious and potentially permanent side effects associated with taking fluoroquinolone antibacterial drugs consistently.