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...

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...

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 Knowle...

T he terms biotechnology and biopharmaceutical describe many complex and important products, technologies, R&D, and industries. Most people, particularly those within the industry, presume that a biopharmaceutical involves biotechnology, but this connection is often ignored or rejected. That causes problems in communication and public perception. This article examines biopharmaceutical terminol...

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...

Multiproduct manufacturing facilities running on a campaign basis are increasingly becoming the norm for biopharmaceuticals, owing to high risks of clinical failure, regulatory pressures and the increasing number of therapeutics in clinical evaluation. The need for such flexible plants and cost-effective manufacture pose significant challenges for planning and scheduling, which are compounded b...

A number of recent improvements in the engineering of high-titer expression vectors, in biopharmaceutical process development, and in facility construction have converged to present new opportunities for cost-effective, f lexible, biomanufacturing facility construction. The evolution of requirements for biopharmaceutical facilities is driven by globalization of the biopharmaceutical industry, p...

Process analytical technology (PAT), the regulatory initiative for building in quality to pharmaceutical manufacturing, has a great potential for improving biopharmaceutical production.The recommended analytical tools for building in quality, multivariate data analysis, mechanistic modeling, novel models for interpretation of systems biology data and new sensor technologies for cellular states,...

OBJECTIVE To describe the implications of a follow-on biologic approval process with focus on current stakeholders, implications of the status quo, and recommendations for future policy. DATA SOURCES A search using Medline, International Pharmaceutical Abstracts, Med Ad News, F-D-C Reports/Pink Sheets, and Google index directories was conducted with terms such as biologic, biopharmaceutical, ...

Background: Biopharmaceutical medicines represent a growing share of the global pharmaceutical market, and with many of these biopharmaceutical products facing loss of exclusivity rights, also biosimilars may now enter the biopharmaceutical market. Objectives: This study aims to identify and document which investment and development strategies are adopted by industrial players in the global bio...