[HTML][HTML] Viral contamination in biologic manufacture and implications for emerging therapies

…, M Murphy, M Plavsic, NJ Roth, D Roush… - Nature …, 2020 - nature.com
Recombinant protein therapeutics, vaccines, and plasma products have a long record of
safety. However, the use of cell culture to produce recombinant proteins is still susceptible to …

Advances in primary recovery: centrifugation and membrane technology

DJ Roush, Y Lu - Biotechnology progress, 2008 - Wiley Online Library
Significant and continual improvements in upstream processing for biologics have resulted
in challenges for downstream processing, both primary recovery and purification ( 1 ). Given …

Domain contributions to antibody retention in multimodal chromatography systems

J Robinson, D Roush, S Cramer - Journal of Chromatography A, 2018 - Elsevier
Although a platform process has been established for purification of antibodies, a deep,
fundamental understanding of how these molecules interact with chromatography resins has yet …

Virus filtration of high‐concentration monoclonal antibody solutions

BF Marques, DJ Roush, KE Göklen - Biotechnology progress, 2009 - Wiley Online Library
The ability to process high‐concentration monoclonal antibody solutions (> 10 g/L) through
small‐pore membranes typically used for virus removal can improve current antibody …

Definition and dynamic control of a continuous chromatography process independent of cell culture titer and impurities

…, H Li, C Cutler, K Lacki, N Tugcu, D Roush - … of Chromatography A, 2017 - Elsevier
Advances in cell culture technology have enabled the production of antibody titers upwards
of 30 g/L. These highly productive cell culture systems can potentially lead to productivity …

Effectiveness of host cell protein removal using depth filtration with a filter containing diatomaceous earth

N Nejatishahidein, EE Borujeni, DJ Roush… - Biotechnology …, 2020 - Wiley Online Library
The increased cell density and product titer in biomanufacturing have led to greater use of
depth filtration as part of the initial clarification of cell culture fluid, either as a stand‐alone unit …

A practical strategy for using miniature chromatography columns in a standardized high‐throughput workflow for purification development of monoclonal antibodies

…, P Rowicki, H Bao, T Linden, DJ Roush… - Biotechnology …, 2014 - Wiley Online Library
The emergence of monoclonal antibody (mAb) therapies has created a need for faster and
more efficient bioprocess development strategies in order to meet timeline and material …

Flow and residence time distribution in small-scale dual-layer depth filter capsules

…, N Nejatishahidein, EE Borujeni, DJ Roush… - Journal of Membrane …, 2021 - Elsevier
Depth filtration is widely used for clarification of liquid feeds, including the purification of
biopharmaceuticals. The performance characteristics of these depth filters can be strongly …

Opportunities and challenges for model utilization in the biopharmaceutical industry: current versus future state

…, J Griesbach, S Hunt, F Insaidoo, D Roush… - Current Opinion in …, 2022 - Elsevier
Processes and manufacturing in the biopharmaceutical industry are mainly based on
experimental data and statistical approaches, however, regulatory expectations of increasing …

On the problem of regioselectivity in the 1, 3-dipolar cycloaddition reaction of munchnones and sydnones with acetylenic dipolarophiles

…, EM Burgess, HL Gingrich, DM Roush - The Journal of Organic …, 1982 - ACS Publications
The 1, 3-dipolar cycloaddition reaction of several unsymmetrically substituted munchnones
and sydnones with methyl propicíate has been examined. The initially formed cycloadducts …