The growth of single-use technology (SUT) has revolutionized the bioprocess industry. The implementation of single-use technology (SUT) has typically been a trial and error exercise for the end users. A publication that provides a road map for...
21 Presentations Featuring 8+ Hours of Content No need to miss out on valuable knowledge-sharing! ISPE has gone through all of our conference presentations from 2020, hand-selected the absolute best and brightest...
Online Live Overview Applying the Biopharmaceutical Manufacturing Facilities Baseline® Guide Principles Using case studies and exercises this course in facility design provides an overview of the concepts utilized in the...
Since the early 1990s, when the “upstart” biotech industry realized that its future success would be heavily influenced by the ability to manufacture multiple products within the same facility,Hill, D., and M. Beatrice. “Biotechnology Facility Requirements, Part 1, Facility and Systems Design.”...
Solano Community College Hosts Advisory Panel to Honor First Graduating Class
On 22 April 2019, more than 40 professionals and students attended the ISPE- Solano Community Advisory Panel at Solano Community College. This event was held in honor of the...
“The FDA is witnessing a surge of cell and gene therapy products entering early development, evidenced by a large upswing in the number of investigational new drug applications. Based on this activity, we anticipate that the number of product approvals...
Continuous biotech manufacturing has the potential to achieve greater product quality at lower cost and shorter time to market. Recent advances in fully integrated control systems and a dynamic market make it more relevant than ever.
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...
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...
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...
