Search results for " characterization" in Articles / App Notes
Article
Impurity Testing of Biologic Drug Products
The requirement to establish an analytical method depends on whether it is for an identity test, content test, or purity/impurity test; whether it is for release, in-process testing, or characterizati…
Article
QbD and PAT in Upstream and Downstream Processing
In the case of biosimilar products, the bioanalytical characterization of the originator product provides another useful input to determine the significance of product and process variability.
Web…
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Biosimilar Quality Requirements
Understanding the physicochemical and biological characteristics of the reference product, doing a full characterization, and familiarizing oneself with publicly available information on the reference…
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Addressing the Complex Nature of Downstream Processing with QbD
…eed for a platform approach to manage the early phases of drug development and conduct more detailed characterization towards late-stage process development,” he says.
To address this challenge, …
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
In this article, the use of SPR in the characterization of bispecific antibodies--including understanding mode of action; defining specific target binding and overall antibody activity; and control of…
Article
Biopharma Advances Demand Specialized Expertise
Lively (PPD): Evolving characterization expectations for biologics have driven improvements in analytical equipment, processes, and systems. Ultra performance liquid chromatography (UPLC) systems have…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Furthermore, the characterization data obtained are essential for product development and regulatory acceptance. Characterization of multiple product batches is essential to demonstrate to the regulat…
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
…n processes by ensuring the quality of raw materials
• Detecting contaminants by characterization of cell banks/virus seed stocks and by testing process intermediates
• Eliminating co…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
New technologies for protein characterization tell us more about particle classification, as opposed to simply providing particle counts. Regulatory agencies are increasingly asking drug manufacturers…
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
“The FDA has been talking about this approach for awhile, meaning they’ll look at the approval of biosimilars as a compilation of all of the evidence and characterization that a company has developed …