Search results for " therapeutic" in Articles / App Notes
Article
Establishment of New Modern Plasma Fractionation Facilities in Asia
…and Development at CSL BioPlasma, Australia, and co-author of Production of Plasma Proteins for Therapeutic Use.
Plasma fractionation is sometimes considered as a conservative industry and less …
Article
Industry Adoption of Single-Use Systems Remains Low
The movement away from the blockbuster drug model to more targeted therapeutics, however, is driving the need for drug manufacturers to avoid costly investments in traditionally large, stainless steel…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Similar issues have been discussed related to applications for Kite Pharma’s therapy for aggressive non-Hodgkin lymphoma and Spark Therapeutics’ new gene therapy to treat a rare condition causing blin…
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From Darwin to Recombinant Fc Multimers
Probably showing the complexity of the interactions, the progress towards the development of therapeutics targeting the Fc-R family for autoimmune and inflammatory diseases has been slow despit…
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Fusion Proteins Pose Manufacturability Challenges
“These molecules are of interest because the domains may have functions that, when combined, are uniquely useful as therapeutics, such as binding/inhibition of cytokines and a longer half-life,” expla…
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Being Thorough When Transferring Technology
…Biologics): The major differences in the technology transfer and process validation approach between therapeutic proteins and other small-molecule therapeutics are due to the complex nature of protei…
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Reconciling Sensor Communication Gaps
For most of the history of the biomanufacture of therapeutic proteins, in-process measurement and control focused on upstream operations. Historically, cell culture and fermentation persist longest am…
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Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) u…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
… animal-component-free processes that have now become standard for producing recombinant antibodies, therapeutic proteins, and some vaccines. Although the same concerns for safety are ultimately expe…
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Microbiological Testing: Time is of the Essence
“Occasionally the therapeutic molecule can have toxic effects on the detector cells that are used to detect viruses in in-vitro assays that comply with ICH Q5A (1) and related regulatory guidelines,” …