Cover: Realizing the promise of any novel viral vector therapeutic depends on the innovator’s ability to constantly meet evolving program requirements set in the product’s preclinical; clinical; chemistry, manufacturing, and controls; and market strategies. A key enabler to success is establishing a robust yet nimble viral vector manufacturing platform that delivers high-quality product on time and in full while managing costs.
Feature:In a recent advanced therapy medicinal products innovator survey, two-thirds of respondents reported that they are developing multiple drug platforms. Without a guarantee of commercial success for any single product, many companies are making smart choices by creating new therapies to tackle di erent diseases and mitigate risk.
Feature:What do recipients of ISPE’s prestigious Facilities of the Year Award (FOYA) know that has helped their projects succeed? What are the lessons learned from achievements in facilities development, including forward-looking projects that encompass and inspire changes in the industry? Pharmaceutical Engineering® spoke with nine FOYA winners from recent years about the lessons they learned and the advice they have for those challenged with building a new facility or renovating an existing one.
Special Report:Operation Warp Speed coordinated US government support of the pharmaceutical industry’s e ort to develop and deliver vaccines and therapeutics across the US to fi ght the COVID-19 pandemic. This article provides an inside look at the work done by this team to address the threat posed by COVID-19.
Special Report:In 2020, the world was grappling with the SARS-CoV-2 virus. In two years, there are multiple vaccines and treatments along with great knowledge about the virus—and about how the industry mobilized, partnered, and achieved tremendous strides in addressing the global pandemic.
Technical:manufacturing challenges beyond those typically addressed by pharmaceutical chemistry. This article analyzes the possibility of transferring a cell and gene therapy process from the cleanroom approach to an environment based on isolation technology or, in other words, of moving the process from an open space manipulation to a closed and segregated space concept.