Search results for " biologics" in Articles / App Notes
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
The problem of copying biologics
Biologic drugs have revolutionized the pharmaceutical industry by attacking disease using the mechanisms of the cell and immune system. These therapies are fragile…
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
By Tom Fletcher, Holden Harris
Regulatory expectations for cell-culture-based biologics production processes changed dramatically once it was discovered in 1996 that a fatal disease (variant Creut…
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Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
Notably, the latter changes, which will take effect in early 2016, include expectations for authentication of key biological and/or chemical resources, such as cell lines, antibodies, and other biolog…
Article
Setting Standards for Biotech Therapeutics in India
With the ongoing shift from small molecules to biologics, the Indian biopharmaceutical industry is also set to replicate the success received by the Indian pharmaceutical companies (Figure 1B) (1). Th…
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Enhancing Resins Addresses Purification Concerns
There are, however, similarities in certain classes of biologics, such as monoclonal antibodies. “Because traditional monoclonal immunoglobulin G (IgG) products share a similar structural and chemical…
Article
An Analytical Approach to Biosimilar Drug Development
That is due to the natural variability and inherent complexity in manufacturing of biologics for which the demonstration of identical quality attributes (pharmaceutical equivalence) as required by the…
Article
Process Chromatography: Continuous Optimization
Improved resin chemistries and customized separation solutions are enabling more efficient separations.
By Cynthia A. Challener
Cell-culture and fermentation are high-…
Article
Single-use Bioreactors Have Reached the Big Time
…k volume for single-use systems, the increased titers of newer cell culture processes, the growth of biologics targeting smaller patient populations and the expanding demand for biosimilars in emergi…
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Moving Biosimilars Forward in a Hesitant Market
However, it is not the same when dealing with biologics because biologics are larger and more complex molecules. Thus, to show that a product is exactly similar, that it would have the same potency, t…
Article
Cell-free Expression Systems Pose Cell Culture Alternative
However, the practicality of using cell-free expression systems in the commercial manufacture of biologics requires proper assessment.
Traditional cell culture struggles
Traditional …