Search results for " biologics" in Articles / App Notes
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…
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Tackling Analytical Method Development for ADCs
“Testing requirements will still be identity, purity, impurities, activity, concentration, and stability as outlined in the International Conference on Harmonization’s ICH Q5C (1) and ICH Q6B (2) biol…
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Labeling of Biosimilars
EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.
Feb 01, 2015
By Sean Milmo
BioPharm International
The European Medicines Agency (EMA) has r…
Article
Setting Up Bioprocessing Systems for Digital Transformation
Bioprocessing is no exception, as the industry continuously seeks to improve large-scale commercial production of traditional biologics, in addition to seeking innovative ways to meet the bioprocessin…
Article
Technology Innovations Improve Process Chromatography Performance
As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.
By Feliza Mirasol
Selecting an appropriate separation technology fo…