New Challenges for Biopharmaceutical Process Development.PDF
ثبت نشده
چکیده
The U.S. Food and Drug Administration (FDA), through the Center for Biologics Evaluation and Research (CBER)/Center for Drug Evaluation and Research (CDER), has long identified that the development of biopharmaceutical products is becoming increasingly challenging, and is inefficient and costly. The agency has also commented that superior product-development sciences are needed to address the challenges — a statement that will affect vendors, biological product developers and manufacturers alike.
منابع مشابه
Challenges and opportunities in biopharmaceutical manufacturing control
The total sales of biopharmaceuticals have been steadily increasing for decades with growing approval of new drug products, especially for monoclonal antibodies. This trend motivates the development of deeper understanding and advancement of biopharmaceutical manufacturing operations. This article describes opportunities, needs, and challenges in process control and operations for biopharmaceut...
متن کاملSmall and Medium Enterprises and Biopharmaceutical Innovations in Africa: Challenges and Prospects
Biopharmaceuticals can be described as medicines or medicinal products manufactured through biotechnological processes with links to biological sources especially those of live organisms or their active components. The biopharmaceutical industry is presently experiencing tremendous revenue growth rates projected at more than $167 billion worldwide in 2015. There are more than 500 biopharmaceuti...
متن کاملBiopharmaceutical Innovation System in China: System Evolution and Policy Transitions (Pre-1990s-2010s)
Background: This article sets up the initial discussion of the evolution of biopharmaceutical innovation in China through the perspective of sectoral innovation system (SIS).Methods: Two data sources including archival documentary data and field interviews were used in this study. Archival documentary data was collected from China Food and Drug Administration (CFDA) and Chinese National Knowled...
متن کاملUtilization of Site-Specific Recombination in Biopharmaceutical Production
Mammalian expression systems, due to their capacity in post-translational modification, are preferred systems for biopharmaceutical protein production. Several recombinant protein systems have been introduced to the market, most of which are under clinical development. In spite of significant improvements such as cell line engineering, introducing novel expression methods, gene silencing and pr...
متن کاملIT solutions for imaging biomarkers in biopharmaceutical research and development
M. Hehenberger A. Chatterjee U. Reddy J. Hernandez J. Sprengel Biomarkers are indicators of normal biological processes, pathogenic processes, or pharmacological responses to a therapeutic intervention. The biopharmaceutical industry is building significant molecular-imaging capabilities and in this context is incorporating biomarker concepts throughout its research. In this paper, we discuss a...
متن کامل