The COVID-19 pandemic has brought increased harmonization and interaction among regulators around the world and the opportunity to consider changes implemented during the pandemic for the long term. Six regulators from five regulatory agencies discussed these issues at the “Global Regulatory Town Hall–The Impact of a Pandemic on Harmonization and...
2020 and the COVID-19 pandemic have presented tremendous challenge to the world and the pharmaceutical industry—but from the pandemic has come stepped up development of vaccines and treatments, increased urgency to address supply chain challenges, and forging ahead to develop and expand of cell and gene therapies. There are lessons to learn from the industry adaptation during these months,...
Twenty-four hours of sessions, mentor circles, book clubs and more with ISPE Women in Pharma® (WIP) took place on 27–28 October. The event had almost 160 registrations for the virtual event, which brought together ISPE members around the world for interactive opportunities to learn and exchange ideas.
Honorable Mention recognizes projects that did not win a specific category but were clearly successful projects that overcame significant challenges in planning, execution, and delivery.
GlaxoSmithKline is the 2020 Facility of the Year Award Winner for Social Impact for their Attachment Inhibitor (AI) Project in Parma, Italy.
United Therapeutics is the 2020 Facility of the Year Award Winner for Social Impact for their Dinutuximab-Dedicated Oncology Medical and Analytical Laboratory in Silver Spring,...
Bristol-Myers Squibb is the 2020 Facility of the Year Award Winner for Project Execution for their Multi-Purpose Cell Culture...
Janssen Pharmaceuticals is the 2020 Facility of the Year Award Winner for Process Innovation for their Mirror 1: A Continuous Manufacturing Platform in Beerse, Belgium.
Eli Lilly and Company is the 2020 FOYA Category Winner for Operational Excellence for their Lilly Innovation Development Center in Indianapolis, Indiana.
Sanofi is the 2020 Facility of the Year Award Winner for Facility of the Future for their Sanofi Digitally Enabled Integrated Continuous Biomanufacturing Facility in Framingham,...
Pfizer, Inc. is the 2020 Facility of the Year Award Winner for Facility Integration for their Andover Clinical Manufacturing Facility (ACMF) in Andover, Massachusetts.
Process validation (PV) aims at reassuring a manufacturer of constant product quality. Moreover, it is a regulatory requirement to achieve licensure of a pharmaceutical product Failing to efficiently plan and execute activities here leads to increased time-to-market. Statistics play a pivotal role here, as is shown by the fact that in the 22 pages of the latest FDA guidance document on process...
The needs of patients must always be at the forefront of what we do.
