Search results for " characterization"
Article
Modeling and Miniaturization: Key Topics at Successful HTPD Conference
Stückler not only showed how the approach could be used for deeper process understanding in early process development, but also the benefits of mechanistic models at the process characterization, vali…
Article
From Darwin to Recombinant Fc Multimers
The session covered both new plasma products as well as products and technologies for plasma processing or characterization. Fabian Käsermann from CSL Behring Switzerland talked further about the Fc m…
Article
Lessons Learned Accelerate Vaccine Development
That deep understanding will be developed through the application of advanced analytical tools for characterization. “Quality by design, high-throughput screening, high-throughput sequencing, small-sc…
Article
Selecting the Right Viral Clearance Technology
By Cynthia Challener, PhD
The introduction of adventitious viral agents is a recognized, inherent risk of biologic drug production that is well addressed by international regulatory requirements…
Article
Breakthrough Drugs Raise Development and Production Challenges
A key decision for manufacturers is whether to devote more resources to the project early to front-load process characterization and validation activities, even before gaining the breakthrough designa…
Article
Taking a “Development-by-Design” Approach to Cell Therapies
“Development by design is needed throughout the process, but the piece we still struggle with the most is mode of action (MOA) and product characterization. Regulatory agencies understand that it is d…
Article
Use of Multivariate Data Analysis in Bioprocessing
…omatography, quantitative assessment of process comparability, root cause analysis, and raw material characterization (3, 4).
In this 33rd article in the “Elements of Biopharmaceutical Production…
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The biosimilars market, many analysts believe, is on the cusp of significant growth. This growth in large part is due to the fact that numerous monoclonal antibody (mAb) biosimilars are expect…
Article
Essentials in Establishing and Using Design Space
Design space is established through proper characterization techniques and is often an extrapolation of the response surface. Two-dimensional contour and three-dimensional surface plots are typically …
Article
Regulatory Challenges in the QbD Paradigm
The regulatory filing in the traditional approach describes the process and presents data on product characterization.
The focus is on presenting the status quo . In a QbD filing, the focus is in…