Quantification methods for viruses and virus-like particles applied in biopharmaceutical production processes

Absolute Quantification of Viral Proteins from Pseudotyped Vesicular Stomatitis Virus (VSV-GP) using Ultra High-Performance Liquid Chromatography- Multiple Reaction Monitoring (UPLC-MRM)

“…The analytical methods employed toward this goal should be precise, quantitative, and reliable to ensure efficient and robust process control during production (2,3). Proteomics-based methods can prove useful for determining protein expression levels during the virus life cycle (3,4).…”

“…The analytical methods employed toward this goal should be precise, quantitative, and reliable to ensure efficient and robust process control during production (2, 3). Proteomics-based methods can prove useful for determining protein expression levels during the virus life cycle (3, 4). While protein expression profiling is now routine in pharmaceutical research, the use of the more targeted MRM approach provides sensitive, accurate, and precise information on viral protein levels (5, 6).…”

“…Knowledge of viral protein expression levels plays an important role in viral vector process development and therefore, a well characterized viral biotherapeutic should include an assay that can monitor the absolute concentrations of the viral proteins in purified drug product (1). The analytical methods employed toward this goal should be precise, quantitative, and reliable to ensure efficient and robust process control during production (2, 3). Proteomics-based methods can prove useful for determining protein expression levels during the virus life cycle (3, 4).…”

Editorial: Advances in bioprocessing of viral vectors and virus-like particles

“…These developments cannot compromise on product quality and purity, and should ideally drive the cost-effectiveness of the process. In order to meet these challenges, scientists focus on the following bioprocess and analytical Research Topic: i) In-process accelerated analytics ( Lothert et al, 2022 ), ii) process automation and data science ( Vormittag et al, 2020 ), and high-throughput technology to speed up process development ( Marchel et al, 2019 ; Hillebrandt et al, 2021 ), iii) process translation from the development scale to the production scale, iv) platform technologies in the area of USP ( Felberbaum, 2015 ; Farzaneh et al, 2017 ; Chambers et al, 2018 ; Tan et al, 2021 ) and DSP ( Marichal-Gallardo et al, 2017 ; Fortuna et al, 2018 ; Hillebrandt et al, 2020 ; Lothert et al, 2020 ), v) continuous manufacturing processes ( Krober et al, 2013 ; Fischer et al, 2018 ; Fortuna et al, 2021 ), vi) single-use technologies and closed systems, vii) modeling of production processes, and (viii) formulation strategies for nanoplexes ( Batty et al, 2021 ). Some of this research is addressed in the following Research Topic.…”

“…These developments cannot compromise on product quality and purity, and should ideally drive the cost-effectiveness of the process. In order to meet these challenges, scientists focus on the following bioprocess and analytical Research Topic: i) Inprocess accelerated analytics (Lothert et al, 2022), ii) process automation and data science (Vormittag et al, 2020), and high-throughput technology to speed up process development (Marchel et al, 2019;Hillebrandt et al, 2021), iii) process translation from the development scale to the production scale, iv) platform technologies in the area of USP (…”