Search results for " biologic" in Articles / App Notes
Article
Biosimilar Quality Requirements
… for biosimilars and marks significant action taken by the agency to help promote competition in the biologic market. In May 2019, the agency published the draft guidance Development of Therapeutic P…
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A Look at the Affinity Chromatography Landscape
Specific binding interactions between biologic molecules and immobilized affinity ligands allow for selective separations. With the advent of next-generation biopharmaceuticals, chromatography materia…
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A Plastic Pipeline for Commercial Bioprocessing?
Adoption for commercial production has been slow; however, as more therapies developed under single-use processes move toward regulatory approval, industry experts expect the percentage of biologic-ba…
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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…
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Aseptic Processing: Keeping it Safe
Louis, MO campus, have spaces that are designed to handle media fill for various types of products and have isolators for both highly potent compounds and biologic products.
While investigational …
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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…
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Viral Clearance Challenges in Bioprocessing
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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…
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Application of Quality by Design to Viral Safety
QbD in the Viral Safety of Raw Materials
A wide variety of biological raw materials can be used in a biopharmaceutical process, ranging from production cells to buffer components to excipients. Th…
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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 …
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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…