Innovation has been and continues to be a driver for the strides being made in biopharma development and manufacturing, noted Eric S. Langer, President and Managing Partner, BioPlan Associates, Inc., who addressed “Innovation in Transformative...
What Does the Industry Want and Need?
Eric S. Langer, President and Managing Partner, BioPlan Associates, Inc., shared these most-needed cell and gene therapy manufacturing improvement, systems, platforms, and infrastructure from his company’s...
Innovations in production methods and technologies that enable a competitive and sustainable biopharmaceutical product supply were the focus of presentations at the 2019 ISPE Biopharmaceutical Manufacturing Conference in Boston, Massachusetts, 18–20 June. Future directions for the biopharma...
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...
