Search results for " biologic"
Article
Viral Clearance Challenges in Bioprocessing
42-44
Removal and inactivation of adventitious and endogenous viruses have traditionally been achieved during the downstream purification of biologics. Viral clearance is assessed in small-scale te…
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Application of Quality by Design to Viral Safety
QbD in the Viral Safety of Raw Materials
A wide variety of biological raw materials can be used in a biopharmaceutical process, ranging from production cells to buffer components to excipients. Th…
Article
Drugs, At What Cost?
In 2002, biologics represented 11% of total drug sales; in 2012, the number was 18%. IMS estimates biologic agents will continue to outpace overall pharma spending growth and will represent 19-20% of …
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Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
Eugene Corretge, speaking on behalf of European Biopharmaceutical Enterprises (EBE), representing both makers of original biologics and biosimilars, said that the revised guideline was unclear about w…
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A Closer Look at Affinity Ligands
Affinity ligands can be used for various purposes, such as detection, purification, or modulation of biological activities. Affinity chromatography is a separation method based on the specific binding…
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Single-Use Technologies Prove Effective for Viral Vector Process Development
While there may be some drawbacks to single-use systems, Tony Hitchcock, technical director at Cobra Biologics, a Charles River company, thinks the benefits far outweigh the problems. “The simple real…
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Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
For example, China’s WuXi Biologics, a contract development and manufacturing organization (CDMO) with global reach, is investing $60 million to build a manufacturing operation in Worcester, MA, in ad…
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Understanding Validation and Technical Transfer, Part 3
When correctly done, linking process to product to patient, validation ensures safe and effective drug and biologic products and benefits the patients whose health and wellbeing depend on them.
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Bioburden Control in the Biopharmaceutical Industry
According to the Public Health Service (PHS) Act and as illustrated in Figure 1, the biological product must be safe, pure, and potent.
The basic standards for establishing …
Article
Contract Manufacturing Through the Years
There wasn’t a biologics contract manufacturing sector, and early entrants such as Amgen and Genentech had to build their own facilities.
Dedicated contract drug-product manufacturers were…