March 2007 Issue
The cherished blockbuster is at the root of many of the industrys problems today. Solving them will depend on an energized industry and an adequately funded FDA.
A new generation of scientists and engineers will be needed to make PAT and QbD a reality, both within companies and regulatory agencies. Training will be the key.
Manhattan in the spring, a bustling show floor and thought-provoking educational sessions provide all the reason anyone should need to attend this years event
As demand for single-use bioprocessing systems increases, manufacturers are establishing safety and performance standards through the Bio-Process Systems Alliance
Agency leaders are redefining science, moving away from early 20th century empiricism and toward a mechanistic understanding of processes, in everything from manufacturing to R&D and clinical trials.
Sustainability not only feels good, it pays off, as a growing number of drug companies are learning.
The waning of the Blockbuster Era has brought massive restructuring, challenging drug makers to foster innovation, teamwork and morale. Merck serves as an example of what can be done.
A strategic approach and external focus are keys to successful innovation
Success requires defining goals and priorities clearly, adopting a project methodology and developing test plans for the entire project life cycle.
The right approach to commissioning can simplify and speed validation, but it requires a multidisciplinary strategy and alignment with overall project goals. A Commissioning Master Plan can ease the transition.