Biopharmaceutical Manufacturing

Video

New Modalities: 2019 ISPE Biopharmaceutical Manufacturing Conference

Andre Walker, CPIP, Chair of the 2019 ISPE Biopharmaceutical Manufacturing Conference offers insights on new modalities in biomanufacturing and why you must be prepared to design, build, operate, and support the new and...
The Rise of Biopharmaceutical Manufacturing in Asia - ISPE Pharmaceutical Engineering
Features
The Rise of Biopharmaceutical Manufacturing in Asia

Biopharmaceuticals are booming in Asia, buoyed by enhanced regulations, an influx of venture capital, a culture of innovation, and government support. Asian pharmaceutical manufacturing has traditionally focused on generics, but things are changing.1

  • 1Liu, A. "AstraZeneca Allies with Alibaba and Tencent as Its China Sales Soar." FiercePharma, 2 February 2018.

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...