Search results for " comparability"
Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Analytical characterization and comparability of biotherapeutics
Biotherapeutics are complex products and, therefore, require characterization using numerous orthogonal analytical tools. Biosimil…
Article
Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
…of the original biopharmaceutical or reference product to which biopharmaceuticals will have to show comparability in quality, safety, and efficacy to be approved as biosimilars.
Revised guide…
Article
Comparing Protein A Resins for Monoclonal Antibody Purification
A prototype Protein A resin is evaluated for purification performance, reusability, and cost performance.
With greater economic pressure on monoclonal antibody (mAb) production for therapeutic …
Poster
Accurate comparability assessment of a biosimilar interferon in process development
This application note describes how to achieve accurate comparability assessments using Biacore™ T200 and
Amersham™ WB system in the development of a biosimilar. This is exemplified in this study…
Article
Biosimilar Quality Requirements
This article reviews FDA’s recent efforts to streamline the biosimilar approval process and address quality concerns with the publication of new guidelines that suggest resources to aid in the biosi…
Article
Regulatory Challenges in the QbD Paradigm
CURRENT REGULATIONS AND COMPARABILITY PROTOCOLS
An overview of current FDA regulations and guidance is helpful to discover hidden opportunities and how they can be leveraged for the QbD paradigm f…
Article
Using Multiple Techniques in Biosimilar Analysis
These occasions may lead to the inability to truly build any orthogonality into the high order structure analytical comparability.
When these issues are encountered, it is key to empirically define…
Article
Elucidating Biosimilars Characterization
Despite advances in analytical chemistry and instrumentation, the direct assessment of comparability from analytical data is limited. Using liquid chromatography-mass spectrometry (LC-MS) methods, we …
Article
Use of Multivariate Data Analysis in Bioprocessing
…les from unit operations such as cell culture and chromatography, quantitative assessment of process comparability, root cause analysis, and raw material characterization (3, 4).
In this 33rd art…
Article
An Analytical Approach to Biosimilar Drug Development
In addition, these analytical tools are required to be more accessible and automated to conduct acquisition, processing, and reporting from characterization and comparability studies that are needed f…