Biopharmaceutical Manufacturing

Breakthrough for Pharma Industry & Patients
Features
Breakthrough for Pharma Industry & Patients - FDA Approved Gene Transfer Therapy

On 30 August, the US Food and Drug Administration (FDA) approved Novartis's Kymriah (tisagenlecleucel, CTL019), the first gene therapy for the treatment of pediatric and young-adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia (ALL). Kymriah belongs to a class of drugs called chimeric antigen receptor (CAR) T-cell therapies, which constitute a form of immunotherapy...

Engineer's Role in the Biopharmaceutical Supply Chain
Special Reports
Engineer's Role in the Biopharmaceutical Supply Chain

As the industry evolves in its quest to increase quality, productivity, efficiency, and safety, engineers must be equipped with skills that enable them to meet new and challenging demands. This first in a two-part series focused on biopharmaceutical manufacturing explores a few of the exciting roles engineers play to drive continuous improvement. Part 2, slated for Pharmaceutical Engineering's...

Online Learning

Understanding Process Validation in Biotechnology Manufacturing

Training
US FDA’s Draft 2008 Process Validation Guidelines provide an excellent framework for understanding Process Validation . They describe the principles and approaches that the FDA feels the industry should use in executing...