March 2006 Issue
Technology, no matter how powerful, can only work as part of an overall strategy of control and continuous improvement.
FDAs Watts and Afnan say process analytical technology is in good hands the industrys.
Aggressive career management is the key to remaining outside the box and avoiding a mid-career crisis.
FDAs recent guidance on pharmacogenomics reduces manufacturers risks in evaluating genomic data. Will it spur development of more targeted therapies?
Initiatives that focus on women and minorities may miss the big picture.
At AstraZenecas Westborough facility, the secret to blow-fill-seal success has been developing broad expertise, and seeing implementation and operations challenges as opportunities for growth.
FDA has yet to issue guidance on biosimilars, but scientific advances promise to aid regulators and enable quality by design.
Multidisciplinary forethought has been the key to making Process Analytical Technology work for fragile protein therapies.
Pharmaceutical and bioscience manufacturers have a new advanced automation toolbox.
Contract manufacturers and intermediates suppliers are raising the bar for chiral chemistry in pharmaceutical development.