Characterization of Biotherapeutic Products

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Background

Characterization of biotherapeutic products is a key aspect and requirement of their successful development and commercialization. The complexity of biotech products and processes, alongside our limited understanding of how quality attributes that define a biotherapeutic impact the product’s safety and/or efficacy in the clinic remain major impediments to more predictive bioprocess development that manufacturers and regulators face. The quality of biotherapeutic products is determined during bioprocessing. The US Food and Drug Administration encouraged the concept called Quality by Design, where the critical quality attributes are analyzed online using Process Analytical Technology. However, the identification of these parameters remains a challenge and the definition of the design window is an important part of the bioprocess design and optimization. Recombinant biotherapeutic proteins are large, complex molecules and require sophisticated analytical and functional characterization to define their critical quality attributes and how these are influenced by process and cell host changes. In addition, the FDA regulations are also going into continuous processing and therefore quick and accurate analytics are important to control their bioproduction.

This collection aims to cover the development of novel analytical and functional techniques alongside recent improvements in existing protein and bioprocess characterization tools that can define recombinant biotherapeutic critical quality attributes. The goal of this issue will be two-fold: first, development of novel analytical and functional techniques alongside the latest state-of-the-art approaches that can be harnessed to define recombinant biotherapeutic critical quality attributes, second, major improvements in existing protein and bioprocess characterization tools, that can provide insights into the critical quality attributes of biotherapeutic proteins or used in bioprocess redesign to improve product yields and quality. Overall, this Research Topic will describe not only current best analytical characterization practices of biotherapeutic products and but also how these can be utilized to enhance yield, quality and safety of such products. The collection will also highlight areas where challenges in analytical characterization remain (e.g. in real time/on-line, for continuous processes) and how these might be addressed.

The scope of the article collection will encompass all topics related to analytical and functional characterization of biotherapeutic products. Some of the topics of interest are listed below:
1. Novel approaches and tools for analytical and functional characterization
2. Major recent developments in existing characterization and screening techniques of biotherapeutics including proteomics
3. Identification of Critical Quality Attributes to facilitate the establishment of the design window of bioprocesses
4. Characterization tools to facilitate process control and PAT
5. Characterization tools to facilitate continuous processing
6. Major developments in instrumentation
7. Gaps in existing methodologies
8. Fingerprinting of biotherapeutics

Keywords: Biotherapeutics, Biosimilars, Characterization, Comparability, Process control

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.

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