Search results for " efficacy" in Articles / App Notes
Article
Tools and Solutions for Separation of Charged mAb Variants
To attain regulatory approval, a comparable quality to the reference product in terms of efficacy, purity, and safety should be demonstrated. Biomolecules, however, exhibit high structural complexity …
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Techniques for Improving Process Development for Exosome-Derived Therapeutics
We want to focus on the ones that relate to the functional characteristics of exosomes and how they might behave from a safety and efficacy standpoint in the clinic. For exosomes, what you look at is …
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Transformative Medicines Challenge FDA and Manufacturers
More controversial was FDA’s approval of Sarepta Therapeutics’ Exondys 51 (eteplirsen) to treat Duchenne muscular dystrophy, due to its reliance on an uncertain surrogate endpoint to demonstrate effic…
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Reliability Rooms and the Move to Proactive Supply Chain Management
Manufacturers must not only speed product delivery but ensure quality, safety, and efficacy. Success demands consistent discipline and rigor from supply chain and manufacturing operations, as well as …
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Platform Technologies Improve Protein Expression
Manufacturers are seeking mechanisms for increasing efficiencies and reducing costs without compromising the safety and efficacy of their drug products. In addition to exploring novel production metho…
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Impact of Media Components on CQAs of Monoclonal Antibodies
These modifications can profoundly affect protein quality relevant to clinical efficacy, safety, and half-life of biologics (1). Mammalian cells meet these criteria quite efficiently by virtue of thei…
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From Darwin to Recombinant Fc Multimers
At PPB 2017, Bosques presented data from preclinical studies and how the drug candidate M230 has demonstrated greater efficacy and 10–40 times greater potency than IVIg in three different animal model…
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Unifying Continuous Biomanufacturing Operations
While the Bayer patent only demonstrated the efficacy of an integrated biomanufacturing train for the production of recombinant blood coagulation Factor VIII, the authors of the patent argued “the inv…
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Witnessing Major Growth in Next-Generation Antibodies
Multi-specific antibodies, on the other hand, have the potential to unlock new mechanism of action and afford significantly improved efficacy. As a new technology with many different approaches, comme…
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Evaluating E&L Studies for Single-Use Systems
The manufacturer is, therefore, responsible to examine various materials used in manufacture of both drug substances and drug products to ensure that the materials are appropriate in terms of efficacy…