Search results for " market" in Articles / App Notes
Article
Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
Today, many Chinese companies are expanding through biosimilars, contract manufacturing organization (CMO) partnering, and other means to reach Western markets. For example, China’s WuXi Biologics, a …
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Reducing Cross-Contamination Risks in Process Chromatography
…tment needs with respect to facility, equipment, and labor, enabling cost savings and faster time to market,” he says. All of the attributes of single-use technologies--reduced process time, faster e…
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Witnessing Major Growth in Next-Generation Antibodies
The global market for next-generation antibodies, including antibody drug conjugates (ADCs), engineered antibodies, bispecific antibodies, antibody fragments, antibody-like proteins and biosimilar ant…
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Efforts Accelerate to Streamline Postapproval Change Process
By Jill Wechsler
Frequent revisions and updates in manufacturing processes and operations are routine after a drug comes to market to improve products and systems and ensure reliable supply of hig…
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Platform Approach Speeds Process Development
The most preferred host cell line is the CHO cell, but other cell types such as the murine myeloma cells (NS0 and Sp2/0) are also still used, mainly for marketed products. For manufacturing of biophar…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
…at the limit for in vitro cell age harvested from the commercial cell-culture process to support the marketing authorization applications. Together, the presented strategy is integrated with other ex…
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Innovative Therapies Require Modern Manufacturing Systems
More biosimilars are poised to come to market in 2016 following FDA approval of the first such therapy in 2015. At the same time, though, the development of such innovative and targeted therapies heig…
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Aseptic Processing: Keeping it Safe
…terile products must have validated processes “of the same standard as for products authorized for marketing,” according to the European Commission’s EU Guidelines to Good Manufacturing Practice: Med…
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A Bright Future for the Plasma Fractionation Industry
There is also a vast difference between the developed and emerging markets. According to Perreault, there is a strong need for global policies and actions to support development, diagnosis, and treatm…
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New Era for Generic Drugs
…s seeking patent extensions and consumers demanding a clearer pathway for bringing low-cost drugs to market. Former FDA officials recalled the challenges in establishing new policies for testing and …