Tag: <span>us fda regulatory</span>

From the Publisher: The Development and Production of Biologics, Plus Addressing the Needs of the FDA

In this BPJ issue, our feature article covers the 50-year history of Vero cells in vaccine applications. You’ll
also learn about trends in the characterization of complex biological products, heart valve preservation,
and patenting issues for single-use products. We also present the possibilities of bio-electrosprays and cell
electrospinning, along with considerations for disposable chromatography. And finally, this issue delves
into nanofiltration and the molecular diagnostics market. And I also want to discuss the fact that, in 2007, the U.S. federal government is continuing to starve the FDA of funding. It is time to fix this…

Read MoreFrom the Publisher: The Development and Production of Biologics, Plus Addressing the Needs of the FDA

Biologics Production

biologics cell electrospinning disposable chromatography heart valve preservation molecular diagnostics patents single-use products us fda regulatory

Biosimilars in the Rest of the World: Developments in Lesser-Regulated Countries

Biosimilars, and related biopharmaceutical biobetters and biogenerics, are still relatively new, but are already starting to impact worldwide biopharmaceutical markets. Most discussions of biosimilars center on developed regions where markets are mature and manufacturing capabilities allow for the cost-efficient manufacture of these complex molecules. This article covers the development of these products outside the United States (US), European Union (EU), and other developed, generally rather affluent and high-technology economy-based countries. To start, we first offer some definitions…

Read MoreBiosimilars in the Rest of the World: Developments in Lesser-Regulated Countries

Biologics Production

biologics regulations biopharmaceuticals biosimilars complex molecules eu regulatory GMP us fda regulatory