Search results for " biologics" in Articles / App Notes
Article
Biosimilar Quality Requirements
Congress created an approval pathway in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) for biological products that are demonstrated to be “biosimilar” to or “interchangeable” w…
Article
A Look at the Affinity Chromatography Landscape
…ands and support systems that enable the separation and purification of not only novel protein-based biologics, but a wide range of other biomolecules, from viral vectors and nucleic acids to cells. …
Article
A Plastic Pipeline for Commercial Bioprocessing?
“In the old days of biologics blockbusters, the model was to have a stainless-steel facility and you supplied the world out of that. Now the model is different,” he says. “There is a lot more pressure…
Article
Biosimilars: Making the Switch Comes with Challenges
A major doubt is frequently their degree of comparability with the original biologics. Yet both regulators and producers believe that more could be done to eliminate uncertainties about biosimilars by…
Article
Aseptic Processing: Keeping it Safe
There are various schemes and equipment, however, that can support minimized interventions when manufacturing sterile biologics in a controlled environment, he says.
Environmental monitoring, when…
Article
Biomanufacturing Outsourcing Globalization Continues
A solid majority of biologics developers indicated in the 2015 study that they will not offshore any of their process development for biomanufacturing over that period, a result that is consistent wit…
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
…
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…