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.
A federal judge entered an order of permanent injunction against Paul W. Franck, the owner and operator of several compounding pharmacies in Florida.
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.
The agency extends the indication of the drug in combination with bendamustine.