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...
1. Introduction
Contemporary communications technologies, particularly those relating to the internet, have the potential to revolutionize pharmaceutical manufacturing practices. The judicious use of network communication tools may benefit manufacturing...
Have you tried designing an ATMP manufacturing facility and found the lack of regulatory guidance challenging and even frustrating. I recently had such an experience.
Advanced Therapy Medicinal Products (ATMPs) are new state of the art therapies that...
Before the advent of integrated computer systems, LIMs, HMI interfaces, comprehensive software, CGMP, BAS, process control systems, PAT, and the use of statistics, manual record keeping was fraught with errors—most of them unintentional. This led to...
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 , 2 In South Korea, biologics powerhouse...
The portfolio sold by today’s global biopharmaceutical industry is fundamentally different than it was even a decade ago. This shift is a reflection of today’s global market, which features greater competition, more treatments for orphan diseases, an...
China’s biological pipeline may take the lead
China and India have demonstrated their capability in good manufacturing practice (GMP) manufacture of small-molecule drugs for decades. But...
Many spend their summer relaxing, perhaps traveling, but generally trying to “put their feet up.” Others change the course of health care as we know and practice it.
Gilead’s 28 August purchase of Kite Pharma, one of the companies developing chimeric...
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...
