Biopharmaceuticals are complex entities that require careful monitoring of their quality attributes throughout their life cycle. To achieve this, a combination of biophysical techniques is used, requiring high-resolution analytical methodologies. This research topic aims to showcase the latest advances in analytical characterization techniques for identifying and quantifying critical quality attributes of biopharmaceuticals.
The growing diversity of biopharmaceutical modalities and manufacturing practices has led to an increased demand for current analytical characterization regimes. As a result, newer methodologies have been developed that incorporate automation and hyphenation, operate in multiple separation dimensions, and can characterize multiple critical quality attributes in a single workflow. Our goal with this research topic is to create a knowledge resource for the next generation of biopharmaceutical scientists in the characterization space.
This collection highlights innovative and emerging analytical characterization methodologies and workflows that allow for integrated analysis of biopharmaceuticals. This includes multi-attribute workflows, automation and hyphenation, on-line/at-line methodologies, and chemometrically or AI/machine learning-enabled workflows. Along with original research articles, we welcome perspective papers on next-generation analytical characterization strategies and platforms in this collection.
Keywords:
Biotherapeutics, Analytical characterization, Multi Attribute Method, Chemometrics, Machine learning, Process Analytical Technology
Important Note:
All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.
Biopharmaceuticals are complex entities that require careful monitoring of their quality attributes throughout their life cycle. To achieve this, a combination of biophysical techniques is used, requiring high-resolution analytical methodologies. This research topic aims to showcase the latest advances in analytical characterization techniques for identifying and quantifying critical quality attributes of biopharmaceuticals.
The growing diversity of biopharmaceutical modalities and manufacturing practices has led to an increased demand for current analytical characterization regimes. As a result, newer methodologies have been developed that incorporate automation and hyphenation, operate in multiple separation dimensions, and can characterize multiple critical quality attributes in a single workflow. Our goal with this research topic is to create a knowledge resource for the next generation of biopharmaceutical scientists in the characterization space.
This collection highlights innovative and emerging analytical characterization methodologies and workflows that allow for integrated analysis of biopharmaceuticals. This includes multi-attribute workflows, automation and hyphenation, on-line/at-line methodologies, and chemometrically or AI/machine learning-enabled workflows. Along with original research articles, we welcome perspective papers on next-generation analytical characterization strategies and platforms in this collection.
Keywords:
Biotherapeutics, Analytical characterization, Multi Attribute Method, Chemometrics, Machine learning, Process Analytical Technology
Important Note:
All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.