Search results for " biologic" in Articles / App Notes
Article
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…
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Tackling Analytical Method Development for ADCs
Their composition--a biologic linked to a small-molecule cytotoxic, which enables targeted delivery--also creates challenges for analytical method development, both for characterization and lot releas…
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Labeling of Biosimilars
They claim that it does not highlight sufficiently the inherent differences between biosimilars and their reference products because being biological, they cannot be identical as small-molecule generi…
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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…
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Technology Innovations Improve Process Chromatography Performance
By Feliza Mirasol
Selecting an appropriate separation technology for biologic manufacturing is a crucial task in maximizing productivity in downstream bioprocessing. Biomanufacturers consider se…