Search results for " biologics"
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…
Article
Application of Quality by Design to Viral Safety
A quality-by-design approach defines a range of potential viral contaminants of source materials and can be used to effectively achieve viral clearance.
Oct 1, 2014
BioPharm International
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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 …
Article
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…
Article
A Closer Look at Affinity Ligands
BioPharm: Why are affinity ligands preferred for biologics purification over other downstream purification techniques?
Elliot (BioCina): Affinity ligands can produce a very high purification facto…
Article
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
This information serves as the foundation for producing material for clinical studies, initial regulatory filings such as investigational new drug applications (INDs) and biologics license application…
Article
Bioburden Control in the Biopharmaceutical Industry
Conclusion
The biologics sector is continually expanding because these drugs demonstrate better therapeutic value in treating an increasing number of chronic diseases (18). Biologics manufacturing…
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…