Search results for " characterization" in Articles / App Notes
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…
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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 …
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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…
Article
Essentials in Quality Risk Management
…target product profile (QTTP), through CQA generation to analytical method selection, unit operation characterization, specification and acceptance criteria limit generation, critical process paramet…
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Milestones and Moderate Progress in 2012 Drug Approvals
First gene therapy and plant-based expression vector products approved in 2012.
In terms of product approvals, the past year can be considered reasonably successful. Twelve biopharm…
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Reviewing the Importance of Biosimilarity and Interchangeability
According to Stamm, biosimilarity studies generate extensive analytical data comparing the biosimilar product’s CQAs with the CQAs of the reference biologic, including physicochemical characterization…
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Unraveling the secrets of poloxamer 188 - A webinar mystery
When an inexplicable drop in cell culture performance is linked to a batch of media, researchers race to find the culprit.
In this on demand recording we will unravel the mystery as we …
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Bracing for a Future Wave of Advanced Therapies
With the help of recent investor interest, progression of advanced therapy medicinal products (ATMPs) in the clinical space continues to move forward. Buoyed by the regulatory approval of sever…