Search results for " characterization"
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…
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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 …
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Mapping a Route for Cell and Gene Therapy Process Development
…ality materials generated by qualified vendors are not available
- A lack of adequate process characterization tools and technologies.
Many of these challenges apply to the development …
Article
Methods Accelerate Biosimilar Analysis
As the foundation in the development of biosimilars is the analytical strategy, this paper reviews effective analytical methodologies available to perform in-depth characterization of both innovator a…
Article
Being Thorough When Transferring Technology
This becomes invaluable to others later, and helps support claims for process characterization and robustness; selection of control and critical parameters; and setting of specifications. A summary of…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
In Part II, the preliminary risk levels of process parameters provided the basis of characterization studies based on design of experiments. Data from these studies were used to confirm the continuum …