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Enhancing Protein A performance in mAb processing: A method to reduce and rapidly evaluate host cell DNA levels during primary clarification
- Source :
- Biotechnology Progress
- Publication Year :
- 2019
- Publisher :
- Wiley, 2019.
-
Abstract
- The use and impact of 3M™ Emphaze™ AEX Hybrid Purifier, a single‐use, fully synthetic chromatographic product, was explored to reduce host cell DNA (HC‐DNA) concentration during the primary clarification of a monoclonal antibody (mAb). An approximately 5‐log reduction in HC‐DNA was achieved at an Emphaze AEX Hybrid Purifier throughput of 200 L/m2. The appreciable reduction in HC‐DNA achieved during primary clarification enhanced Protein A chromatography performance, resulting in a sharper and narrower elution profile. In addition, a 24× improvement in host cell protein (HCP) removal and fewer impurities nonspecifically bound to the Protein A column were observed compared to those resulting from the use of depth filtration for clarification. The use of a rapid, qualitative acidification assay to facilitate HC‐DNA monitoring was also investigated. This assay involves the acidification‐induced precipitation of HC‐DNA, enabling the easy and rapid detection of DNA breakthrough across purification media such as Emphaze AEX Hybrid Purifier by means of turbidimetric and particle size measurements.
- Subjects :
- medicine.drug_class
CHO Cells
Protein A chromatography
Monoclonal antibody
RESEARCH ARTICLES
law.invention
chemistry.chemical_compound
Cricetulus
depth filtration
law
medicine
Animals
DNA reduction
Particle Size
Staphylococcal Protein A
Filtration
Chromatography
Emphaze AEX Hybrid Purifier
Primary (chemistry)
biology
Chemistry
Elution
Precipitation (chemistry)
Antibodies, Monoclonal
DNA
turbidity
Bioseparations and Downstream Processing
biology.protein
Particle size
Protein A
Research Article
Biotechnology
Subjects
Details
- ISSN :
- 15206033 and 87567938
- Volume :
- 35
- Database :
- OpenAIRE
- Journal :
- Biotechnology Progress
- Accession number :
- edsair.doi.dedup.....eaeed6943d54f39bceef7f96f3d8a97a