Due to the complexity of biologic development and manufacturing and the business pressures of the biopharmaceutical industry’s landscape, the margin for error in today’s industry is small. That is why minimizing the threat of contamination is critical when using a closed system for drug development and manufacturing. Yet the traditional method of connecting each step in a closed process can present other risks to the integrity of your product. Therefore, it is important for you to be confident in selecting…
Friday, February 11, 2022 Daily Archives
Bench to Bedside: Why Successful Drug Development Requires a Team Approach
The process from drug development to market approval takes many years and requires both integration and orchestration of several activities based on deep scientific and commercial expertise. We tend to think of drug development as a sequential, phase-driven process during which a product is taken methodically from discovery through preclinical studies, clinical development, and ultimately commercial launch. In reality, development of new drugs is not linear; rather, it requires integrated coordination between collaborators from different functions and stakeholders — from…
J&J fully on board COVID vax despite manufacturing halt reports
With millions of COVID-19 doses on hand and reports that J&J has halted production, we ask whether it has changed its vaccine manufacturing strategy. This week the New York Times reported that Johnson & Johnson (J&J) has temporarily halted production of its COVID-19 vaccine from its Leiden, The Netherlands site claiming that it is producing an experimental “but potentially more profitable vaccine to protect against an unrelated virus,†instead. A spokesperson for J&J told BioProcess Insider its Leiden site “Continues…