Search results for "biosimilar" in Articles / App Notes
Article
Implications of Cell Culture Conditions on Protein Glycosylation
Special cell-culture considerations for biosimilars
Biosimilars are “generic” versions of protein pharmaceuticals that must be highly similar to the innovator drug in order to be classified as such…
Article
Outsourcing Trends in Biopharmaceutical Manufacturing
Trend four: Majority of biosimilars production could be outsourced
One area that might end up being mostly outsourced is biosimilars production. Contract manufacturing organizations (CMOs) are lik…
Article
Framing Biopharma Success in 2016
Peters
The US biopharmaceutical industry turned a new page in 2015 when FDA approved Zarxio (filgrastim-sndz), the first biosimilar approved for use in US markets, in March 2015. Biotechnology sto…
Article
Modular Manufacturing Platforms for Biologics
Modularization of biologics and biosimilars
Emerging markets and the increasing demand for biosimilars may prompt pharmaceutical manufacturers to adopt a “local sourcing” attitude that has histori…
Article
The Future of Biopharma
The current situation in the biopharmaceutical industry is exciting enough, with biosimilars, new technologies, personalized medicines, and opportunities in emerging markets. The industry, however, be…
Article
Best Practices for Selecting a Top-Quality Cell Line
This issue is particularly important for biosimilars, because the glycosylation patterns of biosimilars must meet biosimilarity specifications when compared to the innovator drugs, which can only be a…
Article
Report from India
Enhanced focus on over-the-counter products, vaccines, and biosimilars would start gaining importance in overall business strategies. Companies will look at in-licensing initiatives, comarketing, and …
Article
QbD and PAT in Upstream and Downstream Processing
This also holds for biosimilar products.
McKnight (Genentech): CQAs are defined for the product, not identified as part of upstream or downstream portions of the manufacturing process. There are…
Article
Determining and Optimizing Dynamic Binding Capacity
Dynamic binding capacity (DBC) indicates the quantity of a specific biomolecule that can be bound during a chromatography purification step under a specific set of process conditions. Determ…
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State of the Biopharmaceutical Industry: Lessons from 2018 Survey Data
I also continue to be surprised by the magnitude of efforts in follow-on biopharmaceuticals, particularly biosimilars. BioPlan's Biosimilar/Biobetters Pipeline Directory is now tracking over 1,000 bio…