[HTML][HTML] An updated analysis of viral clearance unit operations for biotechnology manufacturing

OO Ajayi, SA Johnson, T Faison, N Azer… - Current Research in …, 2022 - Elsevier
Viral contamination is a potential risk of using biotechnology products derived from
mammalian cell lines. Therefore, to provide assurance of the safety of these products …

Viral removal by column chromatography in downstream processing of monoclonal antibodies

Y Li - Protein Expression and Purification, 2022 - Elsevier
For monoclonal antibodies (mAbs) produced in mammalian cells, viral safety is a critical
concern. The downstream process, in addition to removing other impurities, needs to ensure …

Characterization of operating parameters for XMuLV inactivation by low p H treatment

S Chinniah, P Hinckley… - Biotechnology …, 2016 - Wiley Online Library
To ensure the viral safety of protein therapeutics made in mammalian cells, purification
processes include dedicated viral clearance steps to remove or inactivate adventitious and …

Virus clearance validation across continuous capture chromatography

J Angelo, S Chollangi, T Müller‐Späth… - Biotechnology and …, 2019 - Wiley Online Library
Multicolumn capture chromatography is gaining increased attention lately due to the
significant economic and process advantages it offers compared with traditional batch mode …

Clearance of the rodent retrovirus, XMuLV, by protein A chromatography

J Bach, L Connell‐Crowley - Biotechnology and …, 2015 - Wiley Online Library
Protein A chromatography is the most common unit operation used in the manufacture of
therapeutic monoclonal antibodies (mAbs) due to its high affinity and specificity for the IgG …

Continued insights into virus clearance validation across continuous capture chromatography

JM Angelo, K Potter, T Müller‐Späth… - Biotechnology and …, 2021 - Wiley Online Library
Multi‐column capture chromatography (MCC) has gained increased attention lately due to
the significant economic and process‐related advantages it offers compared to traditional …

Viral clearance using traditional, well-understood unit operations: session 1.2. Anion exchange chromatography; and session 1.3. Protein a chromatography

D Roush - PDA Journal of Pharmaceutical Science and …, 2015 - journal.pda.org
Viral Clearance Using Traditional, Well-Understood Unit Operations: Session 1.2. Anion
Exchange Chromatography; and Session 1.3. Protein A Chromatography | PDA Journal of …

[HTML][HTML] Understanding virus retention mechanisms on protein a chromatography based on using different wash buffers–Evaluating the possibility for a generic wash …

S Krause, F Capito, V Oeinck, H Flato, H Hoffmann… - Biotechnology …, 2024 - Elsevier
During manufacturing of mammalian-cell derived monoclonal antibodies (mAbs) virus
clearance capacity of the downstream process has to be demonstrated. The protein A …

Characterizing and enhancing virus removal by protein A chromatography

C Pan, A Becerra‐Arteaga, B Tran… - Biotechnology and …, 2019 - Wiley Online Library
Protein A chromatography is an effective capture step to separate Fc‐containing
biopharmaceuticals from cell culture impurities but is generally not effective for virus …

Proceedings of the 2019 Viral Clearance Symposium, Session 2: New Modalities in Chromatography and Adsorptive Filters

R Specht, A Schwantes - PDA Journal of Pharmaceutical Science …, 2022 - journal.pda.org
In Session 2 of the 2019 Viral Clearance Symposium, new outcomes of viral clearance
performance of polishing chromatography and depth filters utilized in the purification …