Search results for " characterization" in Articles / App Notes
Article
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 …
Article
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…
Article
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 …
Article
Preclinical Evaluation of Product Related Impurities and Variants
Second, isolating individual variants in amounts that are sufficient for further analytical characterization that is required for assignment of the modifications or performing a cell based assay for d…
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N-Glycan Analysis of Biotherapeutic Proteins
The impact of glycosylation on protein function means that glycosylation can be a critical quality attribute (CQA), making the characterization of N-glycan structures an essential part of the biothera…
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Managing Residual Impurities During Downstream Processing
USP, in collaboration with its Expert Committee and Panel members, develops public standards that support the development, characterization, and release of therapeutics. USP monographs and associated …
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Several spectroscopic non-destructive techniques, including Fourier Transform Infrared (FT–IR), near-infrared (NIR), and Raman spectroscopy have been used for the identification and characterization o…
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Going Small to Achieve Success on the Commercial Scale
Unlike initial processes that are used during the discovery and early development phases to produce material for characterization, efficacy, safety, and other studies, scale-down models are intended t…