Search results for "biologic"
Article
Process Chromatography: Continuous Optimization
Challener
Cell-culture and fermentation are high-yielding processes that effectively produce complex biologic molecules with desirable bioactivities. Even so, there are many impurities presen…
Article
Single-use Bioreactors Have Reached the Big Time
Commercial choice
As such, Norris sees single-use bioreactor processes designed with the entire workflow in mind, delivering a high quality, optimal biologic titer into the downstream unit operati…
Article
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
One approach that potentially offers the benefit of a “cleaner” biologic product in upstream processing is the use of cell-free expression systems. By producing less waste upstream, there is the poten…
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 In May 2019, the agency published the draft guidance Development of Therapeutic Pr…
Article
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…
Article
Aseptic Processing: Keeping it Safe
In addition, says Satish Singh, research fellow and group leader at Pfizer, “Microbiologically-related recalls have always been a significant portion of the enforcement actions by FDA.” In fact, more …
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…